Original Research

Effectiveness of an Evidence-Based R. Gailey, PT, PhD, FAPTA, Department

of Physical Therapy, University of
Miami Miller School of Medicine,
Amputee Rehabilitation Program: 5915 Ponce de Leon Boulevard, 5th
Floor, Coral Gables, FL 33146 (USA);

A Pilot Randomized Controlled Trial Functional Outcomes Research and

Evaluation (FORE) Center, University of
Miami; and Research Department,
Robert Gailey, Ignacio Gaunaurd, Michele Raya, Neva Kirk-Sanchez, Miami Veterans Affairs Healthcare
Luz M. Prieto-Sanchez, Kathryn Roach System, Miami, Florida. Address all
correspondence to Dr Gailey at:
[email protected].
Background. Despite the prevalence of lower limb amputation (LLA), only a small I. Gaunaurd, PT, MSPT, PhD,

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percentage of people with LLA actually receive physical therapy post amputation and are Department of Physical Therapy,
rehabilitated to their full potential level of function. There is a need for the development of University of Miami Miller School of
a rehabilitation program that targets impairments and limitations specific to people with Medicine; Functional Outcomes
LLA. Research and Evaluation (FORE)
Center, University of Miami; and
Objective. The objective of this study was to determine whether the Evidence-Based Research Department Miami Veterans
Affairs Healthcare System.
Amputee Rehabilitation program would improve functional mobility of people with
unilateral transtibial amputation (TTA) who have already completed physical therapy and M. Raya, PT, ATC, PhD, Department of
Physical Therapy, University of Miami
prosthetic training.
Miller School of Medicine.

Design. This study was a randomized, wait-list control, single-blinded pilot clinical trial. N. Kirk-Sanchez, PT, PhD, Department
of Physical Therapy, University of
Miami Miller School of Medicine.
Setting. This study researched participants who had received postamputation rehabili-
L.M. Prieto-Sanchez, MD, North
tation to varying degrees, either in an inpatient and/or outpatient settings.
Florida Regional Thyroid Center,
Tallahassee, Florida.
Participants. The participants in this study included veterans and nonveterans with
K. Roach, PT, PhD, Department of
unilateral TTA due to dysvascular disease and trauma.
Physical Therapy, University of Miami
Miller School of Medicine.
Intervention. This study included a prescription-based rehabilitation program for [Gailey R, Gaunaurd I, Raya M,
people with amputations. Kirk-Sanchez N, Prieto-Sanchez LM,
Roach K. Effectiveness of an
Measurements. Results were measured with The Amputee Mobility Predictor with evidence-based amputee
(AMPPro) and without a prosthesis (AMPnoPro) and 6-Minute Walk Test (6MWT) at rehabilitation program: a pilot
baseline and at the end of the 8-week intervention. randomized controlled trial. Phys Ther.
2020;100:773–787.]
Results. The intervention group improved on the AMPPro scores (36.4 to 41.7), AMPnoro Published by Oxford University Press
scores (23.2 to 27.1), and 6MWT distance (313.6 to 387.7 m). The effect size for the on behalf of American Physical
intervention was very large (1.32). In contrast, the wait-list control group demonstrated Therapy Association 2020. This work is
no change in AMPPro scores (35.3 to 35.6), AMPnoPro scores (24.7 to 25.0), and 6MWT written by US Government employees
distance (262.6 m to 268.8 m). and is in the public domain in the US.

Limitations. The sample size was small. A total 326 potential candidates were screened Published Ahead of Print:
with 306 unable to meet inclusion criteria or unwilling to participate. January 17, 2020
Accepted: November 24, 2019
Submitted: November 15, 2018
Conclusion. People with unilateral TTA who received Evidence-Based Amputee Rehabil-
itation program demonstrated significant improvement in functional mobility, with most
participants (66.7%) improved at least 1 K-level (58.3%) and greater than the minimal
detectable change (66.7%).

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2020 Volume 100 Number 5 Physical Therapy 773

Evidence-Based Amputee Rehabilitation Program

P
hysical therapist services after lower limb of 12 outcome measures for people with LLA that are
amputation (LLA) can have a meaningful impact generalizable to the Medicare population.26 ,27 The AMP
on physical function and quality of life. People with has been found to correlate with other measures such as
LLA receiving physical therapy are more likely to have walking speed14 ,16 ,28-30 and Time-up and Go, as well as
better prosthetic weight-bearing and mobility, self-report measures of prosthetic mobility.17 It has also
musculoskeletal endurance, walking speed, and prosthetic been found to have good outcome prediction
fit, as well as an increased 1-year survival rate, compared capabilities.14 ,22 ,28 The AMP does have better
with those who do not receive physical therapy.1-4 discrimination between levels of amputation than other
Unfortunately, physical therapist services are only performance-based measures24 and is also easily
received by a few people after amputation.5,6 A review of administered by a variety of clinicians.31 ,32 The AMP also
12,599 veterans with LLA found that only 55% received has the ability to quantify change over time after
rehabilitation services postoperatively, with physical rehabilitation.16 ,29 ,33

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therapy being the most common service.7 Furthermore,
there is a concern that many people receiving The AMP can also be used to guide exercise prescription
postamputation physical therapy are not rehabilitated to for limb loss and prosthetic rehabilitation. Each AMP task
their full potential level of function. In a cohort of 42 is designed to assess a person’s ability to perform specific
people with unilateral LLA who received physical therapy, physical skills at the activity level (general tasks/demands
the majority remained at a high risk for falls at discharge.3 and mobility); in addition, each AMP task is also
Miller et al reported on a cohort of men with dysvascular comprised of a number of components
disease and transtibial amputation (TTA) that impairments (neuromusculoskeletal and movement-related functions)
and limitations persisted even after completing within the body function domain as defined by the
rehabilitation.8 The impairments and activity limitations International Classification of Functioning.15 ,34 To
that persist can manifest into asymmetrical lower limb use successfully complete the task at the activity level, the
when performing everyday activities such as rising from a components at the body function level must be performed
chair, standing, walking, and negotiating environmental correctly. For example, AMP task number 4 assesses the
obstacles such as inclines, declines, or stairs.9-11 These activity of rising from a chair. This task involves several
mobility limitations may place the person at risk for body function components, including organizational skills,
increased secondary health effects such as osteoarthritis, postural control, momentum strategies, and dynamic
low back pain, cardiovascular disease, obesity, and risk for postural stability. The neuromusculoskeletal and
future amputation.12,13 A physical therapy rehabilitation movement-related functions can be further itemized to
program for people with LLA where exercise prescription specific body function impairments for each component of
is determined by performance-based functional the task where limitations in strength, power,
assessment does not exist. Because of the importance of coordination, balance, and speed can be defined. Once the
postamputation physical therapy, there is a need for the limitations at the impairment level are identified, specific
development of a rehabilitation program that targets exercises can be prescribed to address the possible
impairments and limitations specific to people with LLA. deficits associated with each AMP task. If the exercises are
effective in improving the components at the body
The Amputee Mobility Predictor (AMP) is a reliable function level, then the activity level performance will be
performance-based outcome measure (PBOM) that has enhanced, thus improving the quality of the sit-to-stand
been validated for use in people with LLA as a measure of task and producing a higher score on the AMP task and
functional capabilities and mobility without a prosthesis AMP test. By using the AMP, the physical therapist can
(AMPnoPro) or with a prosthesis (AMPPro).14 The AMPPro quantify at the activity level the specific task limitations
score has been used as an activity limitations outcome for the person with LLA and prescribe specific exercises at
measure and has a minimal detectable change (MDC) the body function component level that will address those
value of 3.4 points.15,16 The AMPnoPro and AMPPro scores impairments that limit functional capabilities.
can differentiate between the Medicare Functional
Classification Level (MFCL) or K-Levels as defined by The concept of Evidenced-Based Amputee Rehabilitation
Centers for Medicare/Medicaid Services (CMS).14,17,18 The (EBAR) is relatively consistent with traditional physical
AMP was developed as a measure for people with LLA therapist practice models where the physical therapist
that could discriminate the functional capabilities between assesses the patient, prescribes treatment, treats the
the MFCLs, assist with identifying limitations in functional patient, and reassesses. What may differ with this program
capabilities, and assess prosthetic mobility.14 The AMP has is that, after the patient completes the AMP, the tasks that
demonstrated the ability to discriminate functional received a less than a satisfactory score are identified and
capabilities and mobility in higher functioning19-21 and exercises designed to address the impairment or limitation
lower functioning22-24 people with LLA as well as people are prescribed. The rehabilitation principles and exercises
with bilateral amputations.19,25 The Comparative for people with amputation chosen for EBAR have gained
Effectiveness Review committee for the Agency for widespread acceptance in the clinical community
Healthcare and Research Quality identified the AMP as 1 worldwide.35-47 After a predetermined period of time, the

774 Physical Therapy Volume 100 Number 5 2020

 Evidence-Based Amputee Rehabilitation Program

patient is reassessed to determine the change in function Study Procedures

and if any modification to the exercise program is Each participant received a physical examination for
necessary. An EBAR program that uses PBOM like the medical clearance by the study physician. The study
AMP to assist with clinical decision-making and the prosthetist evaluated the prosthesis for fit, comfort, and
prescription of effective rehabilitation interventions in alignment. All necessary adjustments to the prosthesis
people with LLAs has not been previously described in were made prior to the start of the intervention. Two
the literature. research physical therapists assumed different roles and
were blinded from each other throughout the study. One
The primary purpose of this study was to determine if an physical therapist who administered the AMPPro,
EBAR program will improve the functional mobility of AMPnoPro, and 6MWT at baseline and at the end of the
people with unilateral TTA who have previously 8-week intervention was blinded to group assignment
completed a traditional prosthetic rehabilitation program. (intervention vs wait-list control) and all intervention data.

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We hypothesized that the mobility of people with TTA
receiving the EBAR intervention would improve over an At the conclusion of baseline testing, participants were
8-week period of time, while the wait list control randomly assigned to either the 8-week intervention or
participants would remain unchanged. The secondary wait-list control for 8 weeks. The other physical therapist
purposes of this study were to determine the trajectory of implemented the EBAR program for all participants. The
mobility change over the course of the 8-week EBAR program was administered for 60 minutes, 3 times
intervention and to document pre-post intervention per week for 8 weeks. The AMP and 6-MWT were also
changes in individual AMPPro tasks. administered at the conclusion of weeks 2, 4, and 6 to
assess change in function and modify the exercise
prescription as outlined in the EBAR program. After
Methods repeating baseline testing, participants assigned to the
Study Design wait-list control group were eligible to begin the EBAR
This randomized, wait-list control, single blinded pilot program.
clinical trial was conducted at the Miami Veterans Affairs
Healthcare System (Miami VAHS), Miami, Florida, in
cooperation with the University of Miami Miller School of EBAR Program
Medicine, Department of Physical Therapy. Participants The EBAR program consisted of 5 primary components:
were recruited from clinician referral and clinics by the (1) cardiopulmonary endurance and flexibility, (2) trunk
research and clinical teams from Miami VAHS, Jackson and lower limb strengthening, (3) balance and
Memorial Hospital, and local South Florida prosthetic and coordination, (4) weight-bearing and stance control, and
physical therapy clinics. Every candidate contact was (5) prosthetic gait training.
logged and screened by the lead research physical
therapist to explain the study commitment and determine A combination of cardiopulmonary aerobic and warm-up
eligibility based on predetermined inclusion criteria and exercises was performed for a maximum of 15 minutes at
subsequently enrolled with the Miami VAHS institutional the onset of each treatment session. To avoid any residual
review board-approved consent form. limb issues, regular skin checks were conducted before
and after warm-up as participants progressed from
Appendix 1 illustrates the study design. Participants were non-weight–bearing to partial and then full weight-bearing
male and female between 55 and 80 years of age with with the prosthesis using the following sequence over the
unilateral TTA due to traumatic or dysvascular etiology, at 8 weeks: upper limb ergometry for weeks 1–2,
least 1 year postamputation, fitted with their current progressing from sitting to standing; Nu-Step (TRS 4000
prosthesis for at least 6 months, and had completed Nu-Step Recumbent Cross Trainer) for weeks 3–4, which
traditional postamputation rehabilitation and prosthetic incorporates both upper and lower limb movement and
training. All participants had received postamputation trunk rotation; elliptical machine for weeks 5–6; and
rehabilitation to varying degrees either in an inpatient treadmill walking for weeks 7–8, progressing from
and/or outpatient setting. Participants were excluded if self-selected to moderate walking speed or as tolerated for
they presented with severe cardiac or pulmonary disease, 15 minutes. The participant’s heart rate and perceived
poorly controlled metabolic disease, nonhealing wounds, exertion were monitored by the physical therapist.
limiting musculoskeletal diagnoses, neurological disorders, Flexibility exercises were performed for the lower limbs,
or prosthetic fit issues. Participants were excluded if they pelvis, and trunk. Participants received from the physical
scored a 43 or higher on the AMPPro, indicating that they therapist a manual stretching program for weeks 1–2 and
were functioning at the MFCL K4-level (43–47pts) and not then progressed to a 10-minute self-stretching program.
requiring the EBAR program, which focused on basic
mobility skills. Estimated AMP score ranges were used to The remaining 35 minutes of the physical therapist
classify participants to the respective MFCLs: K1 (15–26 session followed the exercise program outlined in the
points), K2 (27–36 points), and K3 (37–42 points). EBAR program (trunk and lower limb strengthening,

2020 Volume 100 Number 5 Physical Therapy 775

Evidence-Based Amputee Rehabilitation Program

balance and coordination, weight-bearing and stance enables the clinician to address multiple AMP tasks with
control, and prosthetic gait training), which were guided similar exercises and facilitated the progression of
by the performance on each AMP task. If the participant exercises as function improved without overwhelming the
scored either a 0 (inability to perform the task) or 1 point participants with too many different exercises.
(minimal level of achievement or with some assistance)
out of 2 points (independence or mastery of task) on an
AMP task, specific exercises that address the impairment
Outcome Measures
were prescribed.18 Exercises corresponding to tasks with AMP. AMP is a measure of functional capability of a
scores of 0 points would take priority over scores of person with amputation to ambulate with (AMPPro) or
1 point during exercise selection; however, the treating without a prosthesis (AMPnoPro).14 As previously
physical therapist could select the exercises from the task described, the AMP can be easily administered
menu that in their professional judgement would best (10–15 minutes) and requires standard equipment

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serve the participant (Appendix 2). typically found in a clinical setting.

For example, if at baseline testing a participant scored The 6MWT is considered a measure of overall mobility,
0 points (unable to vary walking cadence in a controlled endurance, and physical functioning in the adult and
manner) or 1 (asymmetrical increase in cadence in a geriatric population as well as for people with LLA.33 ,48
controlled manner) on AMP Task #18 (Variable Cadence), Administration of the 6MWT was consistent with
they present with impairments related to single limb recommendations by the American Thoracic Society.49 The
balance, prosthetic gait control (transverse pelvic rectangular course dimensions were 60 feet (18.28 m) by
rotation), and dynamic postural stability. The treating 30 feet (9.14 m) for a total distance of 180 feet. At the
physical therapist would choose from the exercises that completion of the 6MWT, the distance walked was
corresponded with AMP Task #18 that are designed to recorded in meters. The MDC for the 6MWT for those with
address and improve those impairments: stool stepping, LLA is 45 m.16
trunk rotation, resisted walking, and speed training to
increase step frequency.18 Stool stepping promotes stability
Statistical Analysis
within the stump socket interface and weight-bearing
Descriptive statistics were calculated to describe the
through the prosthesis, controlled displacement of center
intervention and wait-list control groups. Student’s t tests
of mass over the base of support, and speed of
and chi-square statistics were calculated to compare the
contraction for hip and knee musculature. Trunk rotation
baseline characteristics between the 2 groups. A 2-group
in opposition to pelvic rotation promotes balance and
repeated-measures analysis of variance was used to
momentum during gait. Resisted walking promotes power
compare the change in AMPPro and AMPnoPro scores
and balance over the prosthetic foot to facilitate equal
and 6MWT distance of the intervention and wait-list
stride length. Speed training focused on equal step length
control groups. Effect sizes were calculated for change in
between limbs with improved single limb balance helps
AMPPro, AMPnoPro, and 6MWT separately for the
promote the ability for increased cadence and, as a result,
intervention group and wait-list control groups.
fast walking speed or the ability for variable cadence.
The secondary analyses used data from the 9 intervention
All exercises designed to address impairments identified
group participants and 3 wait-list control group
at baseline testing were prescribed during weeks 1 and 2.
participants who had successfully completed the entire
The exercises were progressed by increasing the
8-week intervention. In addition to the blinded
repetitions or changing the surface (noncompliant to
information collected at baseline and 8 weeks, the
compliant to dynamic), direction of movement (uni-planar
AMPPRO, AMPnoPro, and 6MWT data collected at weeks
to bi-planar to multi-planar), speed (slow to fast), position
2, 4, and 6 to guide exercise prescription were analyzed.
(supine to sitting to standing), and/or resistance (no
Single-group repeated-measures ANOVAs were calculated
resistance to manual resistance to weighted resistance or
to examine intervention-related changes across the 5 time
resistance bands). Participants were retested on the
periods in AMPPRO, AMPnoPro, and 6MWT performance.
AMPPro and AMPnoPro after the conclusion of week 2. If
Where the ANOVAs were significant, paired t tests were
their scores improved but did not achieve a maximal score
used to examine change between 2 relevant time periods.
on an AMP task, those exercises were continued and
A frequency table was generated to examine pre-post
progressed for the next 2 weeks. If they demonstrated a
intervention change at the item level.
maximum score on the AMP task, then those exercises
were discontinued and alternate exercises were prescribed
based on their performance with other AMP tasks. Several Role of the Funding Source
AMP tasks assess related components within a body This study was supported by the Department of Veterans
function domain; as a result, 1 exercise could be Affairs and Rehabilitation Research and Development
prescribed to address impairments related to 2 or more Services, which played no role in the design, conduct, or
AMP tasks. The previously described exercise program reporting of the study.

776 Physical Therapy Volume 100 Number 5 2020

 Evidence-Based Amputee Rehabilitation Program

Results pairwise comparison of the AMPPro, AMPnoPro, and

Eighteen people with TTA were enrolled in the study, with 6MWT distance across the 5 intervention time periods. No
2 participants in the wait-list control group withdrawing change occurred within the first 2 weeks. After 4 weeks,
for medical conditions unrelated to the study. Nine of the significant change occurred with the AMPPro score. Both
18 participants completed the EBAR intervention and 7 significant statistical and clinical change in AMPPro and
completed the wait-list period. Two participants AMPnoPro scores, and 6MWT distance occurred between
randomized to the wait-list control group voluntarily baseline and weeks 6 and 8 (Tab. 4), where mean change
withdrew from the study. The mean age was 63.25 years, exceeded MDC for the measures.16 Missing data from
mean time since amputation was 8.1 years, 81.2% were Tables 3 and 4 were the result of participants’
male, and 75% lost their limb because of peripheral noncompliance and not completing all testing intervals.
vascular disease or diabetes mellitus. Participants in the
intervention and wait-list control groups did not differ in The item level analysis (Fig. 2) revealed participants

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their demographic characteristics or PBOM baseline demonstrated deficits in 21 of the 25 total tasks. A large
measures (Tab. 1). The mean number of PT treatments per proportion of the participants initially demonstrated
week was 2.5 sessions. deficits in the more challenging AMP tasks. Post
intervention, participants improved in performance in up
Table 2 presents the repeated-measures ANOVA group × to 9 tasks with the mean improvement of 5 tasks. For the
time interaction between the intervention group and the entire cohort (n = 12), there was an improvement of 58
waitlist-control group at baseline and 8 weeks. The points and only a 5-point decline.
intervention group’s mean AMPPro score increased from
36.4 to 41.7 while the wait-list control group’s score
remained unchanged from 35.3 to 35.6 (P = .004) Discussion
(Tab. 2). The mean change in AMPPro of 5.3 points for the Even though the participants enrolled in this study were
intervention group exceeds the AMPPro MDC (3.4 many years postamputation and post rehabilitation, those
points).16 Similarly, the AMPnoPro mean score of the who received the 8-week EBAR program demonstrated
intervention group improved from 23.2 to 27.1, while the clinically significant improvement in mobility as measured
wait-list control group score also remained unchanged by the AMPPro, AMPnoPro, and 6MWT. The wait-list
(24.7 to 25.0; P = .04). The 6MWT distance of the control group participants remained unchanged during
intervention group improved from a mean of 313.6 m to the wait period and those who completed the EBAR
387.7 m (P = .04), while the wait-list control group again intervention also demonstrated significant improvement.
demonstrated virtually no change (262.6 m to 268.8 m). The intervention group pre-post intervention
The mean change in 6MWT distance of 74.1 m exceeds effect size for the AMPPro (1.32) was twice that
the 6MWT MDC (45 m).16 The effect size of the EBAR for the AMPnoPro. This suggests that the physical therapy
program for the intervention group was very large (1.32) exercises focused on prosthetic training are effective
for change in AMPPro scores. The AMPnoPro score and for improving prosthetic mobility and function. The
6MWT distance had a moderate to large effect size (0.68 AMPPro tasks with greatest improvement were step length
and 0.53, respectively). prosthetic limb (3 points/25%), step length sound limb
(5 points/42%), foot clearance sound limb (3 points/25%),
Seven participants (58.33%) improved at least 1 MFCL variable cadence (7 points/58%), stepping over an
K-level, with 2 of those participants improving 2 MFCL obstacle (6 points/50%), ascending stairs (6 points/50%),
K-levels (K2-level to K4-level). Seventy-five percent of the and descending stairs (4 pts/33%). Because the majority of
participants who completed the EBAR program participants in this study had moderate to high functional
demonstrated improvement in AMPPro greater than the capabilities, the targeted exercises were designed
MDC (3.4 pts).16 to improve strength, muscular endurance, balance, and
coordination with both lower limbs that would improve
Only 3 of the 7 participants who were randomized to the prosthetic control and function. These findings suggest
wait-list period completed the 8-week EBAR program. that people with LLA have the potential to benefit from
Two were lost to follow-up and 2 could not complete the an EBAR program with a more targeted exercise approach
intervention due to medical complications not related to after they have recovered from surgery and completed
the EBAR program participation (Fig. 1). The 9 postamputation rehabilitation. The absence of change
participants in the intervention group and the 3 in the wait-list control participants indicates that simply
participants in the wait-list group who crossed over and walking with the prosthesis is not sufficient for continued
completed the intervention were part of a secondary improvement of functional mobility and that skilled
analysis examining the effects of the EBAR intervention physical therapy is required to facilitate prosthetic mobility
over time. Table 3 describes the significant improvement skills.
in AMPPro and AMPnoPro scores (P .0001, respectively)
and 6MWT distance (P = .0006) across the 5 intervention The secondary analysis of the cohort who completed the
time periods (Tab. 3; Fig. 1). Table 4 describes the EBAR intervention suggests that significant improvement

2020 Volume 100 Number 5 Physical Therapy 777

Evidence-Based Amputee Rehabilitation Program

Table 1.
Participant Baseline Characteristics and Self-Report and Performance-Based Outcome Measures for Those
Randomized to the Intervention and Wait-List Control Groupa

Characteristics Intervention Group (n = 9) Wait-list Control Group (n = 7) P

Sex, no. (%)
Men 6 (67) 7 (100)
Women 3 (33) 0 (0)

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Race, no. (%)
Caucasian 1 (11) 4 (57) .10
African American 8 (89) 3 (43)
Cause of amputation, no. (%)
DM 4 (44) 1 (14)
PVD 0 (0) 3 (43)
DM and PVD 1 (11) 3 (43)
Trauma 3 (33) 0
Tumor 1 (11) 0
Age, y
Mean (SD) 63.4 (11.5) 63.00 (7.1) .93
Range (44–78) (54–75)
Time since Amputation, y
Mean (SD) 11.6 (11.4) 4.22 (4.3) .13
Range (1.7–19.0) (1–8.2)
Height, cm
Mean (SD) 177.0 (8.4) 173.2 (8.4) .39
Range (166.4–188.0) (158.8–188.0)
Weight, kg
Mean (SD) 100.6 (25.5) 95.8 (29.8) .73
Range (63.5–140.6) (70.3–142.9)
ABC, points
Mean (SD) 65.0 (18.72) 68.4 (25.2) .76
Range (21–90) (47–88)
AMPPro, points
Mean (SD) 36.4 (4.0) 35.3 (2.4) .51
Range (29–42) (33–40)
AMPnoPro, points
Mean (SD) 23.2 (5.7) 24.7 (5.3) .60
Range (15–32) (17–31)
6MWT, m
Mean (SD) 313.6 (138.9) 262.6 (132.4) .47
Range (97.4–505.8) (89.8–432.1)
a
ABC = Activities Balance Confidence Scale; AMPnoPro = Amputee Mobility Predictor without a prosthesis; AMPPro = Amputee Mobility
Predictor with a prosthesis; DM = diabetes mellitus; 6MWT = 6-Minute Walk Test; PVD = peripheral vascular disease.

778 Physical Therapy Volume 100 Number 5 2020

 Evidence-Based Amputee Rehabilitation Program

in prosthetic mobility as measured by the AMPPro

Group x Time
occurred by week 4 with the greatest change occurring by
Interaction
week 6 and significant improvement found in both AMP

.004b

.04b
(P)

.04b
tests. By week 8, all 3 measures demonstrated significant
improvement. As expected, the 6MWT distance increased
steadily over the course of treatment as strength, muscular
endurance, and aerobic capacity improved, as did the
distance walked, reaching a statistically significant
Effect Size

0.006 improvement of 16% at week 8 (332 m progressing to

396 m). The change in walking speed and distance is
0.12

0.05
consistent with other randomized controlled trial studies
that used a specific exercise program in people with
c

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LLA.50 Interestingly, previous work suggests that the
Wait-list Control Group (n = 7)

estimated mean 6MWT distance for the K2-level is 190 m,

Change Mean

300 m for K3-level, and 400 m for K4-level.14 This small

(SD) Range

AMPPro = Amputee Mobility Predictor with a prosthesis; AMPnoPro = Amputee Mobility Predictor without a prosthesis; 6MWT = Six-Minute Walk Test.
(−88.5–68)
6.2 (52.2)
0.3 (3.7)

0.3 (2.8)

cohort did have some participants with greater than

(−6–5)

(−5–4)

expected mean distances for the 6MWT; however, the

median distance for the entire group was 274 m at
baseline progressing to 419 m at week 8.
(55.7–435.8)
(SD) Range
Post Mean

There were 5 participants who were K2-level and 7

35.6 (5.4)

25.0 (6.2)
(28–43)

(18–35)

(157.4)
268.8

K3-level participants at baseline, with 7 of the 12 (58%)

progressing 1 or 2 K-level(s) with a mean AMPPro
Comparison Between Intervention and Wait-list Control Groups on Pre-post Intervention Changea

increase of 6.3 points by week 8 and an average increase

in 6MWT distance of 48.9 m. One K2-level and 3 K3-level
(89.8–432.1)
(SD) Range

participants remained within their MFCL; however, all

Pre Mean

35.3 (2.4)

24.7 (5.3)
(33–40)

(17–31)

(132.4)
262.6

participants improved with their AMPPro scores and

6MWT distance an average of 3 points and 104.3 m,
respectively. The EBAR program identifies physical
impairments related to lower body strength, muscular
endurance, coordination, balance, postural control, and
Effect

1.32

0.68

0.53
Size

speed of movement that are assessed at the activity level

with sitting and standing balance activities, transfers,
c

walking, and ascending and descending stairs. Target

exercises at the impairment level can help to improve
Change Mean

(−30.2–164.2)
(SD) Range

many different functional activities beyond just walking.

74.1 (63.0)
5.3 (1.92)

3.9 (3.4)
(3–9)

(0–9)

The participants in this study were able to perform sitting

Intervention Group (n = 9)

activities and transfers and could ambulate with adequate

foot clearance, step length, and step continuity. If a cohort
of people with LLA who had lower level functional
Post Mean (SD)

(143.3–571.1)
387.7 (130.6)

capabilities (K1-level and K2-level) had enrolled in this

41.7 (4.0)

27.1 (5.7)
(35–45)

(15–35)
Range

Repeated-measures ANOVA group × time interaction.

study, it would be interesting to see where the

improvement in function occurred and how much
Individual group pre-post intervention effect size.

improvement would take place over time. The AMPPro

tasks that presented the greatest difficulty were single
limb balance, variable cadence, stepping over an obstacle,
Pre Mean (SD)

and stairs. These tasks have been found by previous

313.6 (138.9)

(97.4–505.8)
36.4 (4.0)

23.2 (5.7)

investigators to be predictors of function in people with

(29–42)

(15–32)
Range

LLAs.23,51 Although some participants did improve with

these tasks, for example 58% improved cadence variance,
single limb balance on either limb was not improved. It
was not possible to determine if participants had reached
their maximal potential or if alternative treatment
AMPnoPro,
PBOM

strategies would have yielded greater improvements.

6MWT, m
AMPPro,
Table 2.

Postamputation rehabilitation is inconsistent across the

Range

Range

Range
points

points

various treatment settings with many clinicians using

standard treatment protocols focused on discharge criteria
b
a

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Figure 1.
Mean change in AMPPro scores across the intervention intervals.

Table 3.
Change Across the Intervention Intervals in the Combined Intervention and Wait-List Groupsa

0 Interval 1 Interval 2 Interval 3 Interval 4

P
Baseline 2 wk 4 wk 6 wk 8 wk
AMPPro, points 35.2 (4.2) 37.83 (3.9) 39.9 (3.0) 40.5 (3.7) 42.1 (3.6) <.0001
[Mean (SD)]
Range 29–43 28–42 33–42 32–45 35–45
n n = 12 n = 12 n = 12 n = 12 n = 12 n = 12
AMPnoPro, points 25.0 (6.3) 24.83 (5.5) 27.1 (5.0) 30.3 (4.1) 28.2 (5.4) <.0001
[Mean (SD)]
Range 15–35 14–34 16–33 22–36 15–35
n n = 12 n = 12 n = 12 n = 10 n = 12 n = 10
6MWT 332.4 (130.3) 336.85 (113.9) 356.0 (131.0) 348.4 (131.3) 395.9 (113.8) .0006
Test distance 97.4–505.8 110.35–495.5 118.6–531.3 101.5–556.3 143.3–571.1
(m) n = 12 n = 11 n = 11 n = 10 n = 12 n = 10
a
AMPnoPro = Amputee Mobility Predictor without a prosthesis; AMPPro = Amputee Mobility Predictor with a prosthesis; 6MWT = 6-Minute Walk Test.

rather than using information based in evidence, such as For these reasons, the investigators believed that the
using PBOM to determine physical impairments and majority of secondary issues would be resolved, allowing
limitations. Prosthetic gait training, typically administered participants to focus on improved prosthetic mobility, if
a few weeks after surgery, is often insufficient for they were given additional physical therapy 1 year
proficiency with a prosthesis. Many factors contribute to postamputation. Approximately one-half of participants
the person not reaching their prosthetic potential during enrolled in this study were people with K2-level function
the first bout of physical therapy, including, residual limb defined as household ambulators/limited community
healing, pain, physical deconditioning, psychosocial ambulators; however, the EBAR program progressed the
adjustment to the loss of the limb, and simply the need for majority of participants to K3-level community
time to heal.52–54 In addition, the rehabilitation goals and ambulators. Rehabilitating people to an activity level that
expectations can be low, resulting in the prescription of permits community participation is the long-term goal of
basic prosthetic componentry and limited access to the most rehabilitation programs because it can positively
appropriate physical therapy. Evidence also suggests most influence a person’s quality of life. This study
people with amputations do not progress beyond the level demonstrates that a targeted rehabilitation program
of function achieved at discharge from acute posttraditional rehabilitation period can significantly
rehabilitation.55 improve prosthetic mobility.

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 Evidence-Based Amputee Rehabilitation Program

Table 4.
Pairwise Comparison of Change in AMPPro, AMPnoPro, and 6MWT by Intervention Intervalsa

AMPnoPro Change AMPPro Change 6MinWalk Change

Time Intervals Mean (SD) Min-Max P Mean (SD) Min-Max P Mean (SD) Min-Max P
Participants Participants Participants
−0.2 0.6 13.8
(3.1) .86 (3.8) .61 (39.1) .27
Week 0–2
−5–6 −4–10 −60.0–65.3
n = 12 n = 12 n = 11
2.1 2.7 32.95

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(4.1) .10 (3.3) .02b (60.8) .10
Week 0–4
−5–9 −2–8 −54.6–147.2
n = 12 n = 12 n = 11
4.1 3.2 43.7
b b
(3.8) .008 (2.7) .001 (81.9) .13
Week 0–6
−1–12 −2–7 −90.7–147.9
n = 10 n = 12 n = 10
3.2 4.8 63.5
(3.7) .01b (2.6) <.0001b (61.2) .004b
Week 0–8
−2–9 0–9 −30.2–164.2
n = 12 n = 12 n = 12
2.0 0.5 7.3
(2.0) .01b (2.5) .44 (43.23) .61
Week 4–6
−2–5 −5–4 −76.0–75.7
n = 10 n = 12 n = 10
−0.3 1.6 33.48
(1.8) .62 (1.9) .02 (36.7) .02
Week 6–8
−3–3 −2–5 −2.6–103.5
n = 10 n = 12 n = 10
a
6MWT = 6-Minute Walk Test; AMPnoPro = Amputee Mobility Predictor without a prosthesis; AMPPro = Amputee Mobility Predictor with a Prosthesis;
n = number of participants.
b
Statistically significant difference.

Limitations and Future Studies these types of studies and the need for intervention
The sample size for this study was small. The investigators research with larger populations.50 As described in the
approached 326 potential candidates for this intervention introduction, the issue of low research rehabilitation
study, offering a comprehensive preenrollment medical participation by people with LLA is consistent with the
evaluation, an 8-week PT intervention program, financial literature and requires further understanding and
compensation for transportation to and from the study investigation with respect to the motivation and reasons
site, and any required therapies at the conclusion of the for participation or nonparticipation in physical therapy
study. A total of 306 people were unable or declined to rehabilitation. Although the primary analyses achieved
participate in the study. Because those who were asked to statistical significance, some aspects of the secondary
enroll chose to decline, no informed consent was signed, analyses did not. This may be attributed to low statistical
data concerning reasons for nonparticipation were not power. Sample size was affected by the inability of 2 of
obtained, and participants who enrolled introduced the wait-list control group participants to complete the
self-selection bias to the study. Wong’s (2016) systematic EBAR program due to decline in medical status and 2
review of 8 randomized controlled trial studies using participants who withdrew for unknown reasons.
exercise interventions in people with LLA found all other
studies had similar enrollment with a range of 4 to 58 This pilot intervention study produced questions by
participants, illustrating the relatively low participation in investigators for future work. For instance: when is the

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Figure 2.
Pre-post intervention by AMPPro task.

best time after amputation surgery to administer specific sessions per week. Most people who completed the EBAR
exercises, what is the appropriate duration for physical program improved their AMP score, 6MWT distance, and
therapy, how do we know when a patient has reached functional K-level.
their maximum potential, and should alternate exercises
be added to the EBAR program? Moreover, the impact of
the EBAR program during the acute phase of Author Contributions and Acknowledgments
rehabilitation—when sitting balance, transfers, and
standing with or without a prosthesis is the focus of Concept/idea/research design: R. Gailey, M. Raya, N. Kirk-Sanchez,
physical therapy—is not known. Because there was so K. Roach
much improvement with this cohort, people with LLA Writing: R. Gailey, I. Gaunaurd, M. Raya, N. Kirk-Sanchez, K. Roach
should return to physical therapy regularly to receive Data collection: R. Gailey, I. Gaunaurd, M. Raya,
L.M. Prieto-Sanchez
EBAR over a lifetime for each new replacement prosthesis
Data analysis: R. Gailey, I. Gaunaurd, N. Kirk-Sanchez, K. Roach
to maintain function or to reduce the risk of secondary Project management: R. Gailey, I. Gaunaurd
health effects associated with age and long-term Fund procurement: R. Gailey, K. Roach
prosthetic use. Providing participants: R. Gailey, I. Gaunaurd
Providing facilities/equipment: R. Gailey
The EBAR program and targeted exercise prescription can Providing institutional liaisons: R. Gailey
significantly improve the efficacy of PT rehabilitation for Consultation (including review of manuscript before submitting):
M. Raya, K. Roach
people with TTA with the potential application for other
patient populations. Future EBAR research should include
a multi-site study at Veteran Affairs facilities and private The authors thank John Bowker, MD, Curtis Clark, PT, Steve
sector hospitals that care for people with LLA. This study Decida, CPO, Rafael Hernandez, PT, MSPT, Thomas Dowell, CPO,
demonstrated that people with unilateral TTA can improve Richard Ward, MD, and Ronald Tolchin, MD, for their dedication
and countless hours of work contributed to make this project a
their prosthetic mobility after participating in an EBAR
success. The authors also thank the staff at the Miami Veterans
program when targeted exercises are prescribed based on Affairs Healthcare System Research, Physical Medicine and
the objective findings of the AMP. Physical therapy Rehabilitation and Prosthetics Departments, the University of
rehabilitation designed to address impairment level Miami Miller School of Medicine Department of Physical Therapy,
limitations can improve activity level tasks and mobility and Jackson Memorial Hospital for their generous support of this
over 8 weeks of physical therapy administered 2 to 3 research project.

782 Physical Therapy Volume 100 Number 5 2020

 Evidence-Based Amputee Rehabilitation Program

Ethics Approval people with unilateral transtibial amputation. J Rehabil Res

Dev. 2013;50:941–950.
This study was approved by the Human Studies Subcommittee 12 Robbins CB, Vreeman DJ, Sothmann MS, Wilson SL, Oldridge
and Institutional Review Board at the Miami Veterans Affairs NB. A review of the long-term health outcomes associated
Healthcare System. with war-related amputation. Mil Med. 2009;174:588–592.
13 Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of
secondary physical conditions associated with lower-limb
Funding amputation and long-term prosthesis use. J Rehabil Res Dev.
2008;45:15–29.
This study was supported by the Department of Veterans Affairs 14 Gailey R, Roach K, Applegate B, et al. The amputee mobility
and Rehabilitation Research and Development Services (grant predictor: an instrument to assess determinants of the lower
number A3381R), which played no role in the design, conduct, or limb amputee’s ability to ambulate. Arch Phys Med Rehabil.
2002;83:13–27.
reporting of the study.
15 Kohler F, Cieza A, Stucki G, et al. Developing core sets for

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persons following amputation based on the international
Clinical Trial Registration classification of functioning, disability and health as a way to
specify functioning. Prosthet Orthot Int. 2009;33:117–129.
The clinical trials registration number for this study is 16 Resnik L, Borgia M. Reliability of outcome measures for
NCT00126126. people with lower-limb amputations: distinguishing true
change from statistical error. Phys Ther. 2011;91:555–565.
17 Hafner BJ, Gaunaurd IA, Morgan SJ, Amtmann D, Salem R,
Disclosures Gailey RS. Construct validity of the prosthetic limb users
survey of mobility (PLUS-M) in adults with lower limb
The authors completed the ICMJE Form for Disclosure of Potential amputation. Arch Phys Med Rehabil. 2017;98:277–285.
Conflicts of Interest and reported no conflicts of interest. 18 Samuelsen BT, Andrews KL, Houdek MT, Terry M, Shives TC,
Sim FH. The impact of the immediate postoperative prosthesis
DOI: 10.1093/ptj/pzaa008 on patient mobility and quality of life after transtibial
amputation. Am J Phys Med Rehabil. 2016;96:116–119.
19 Li WS, Chan SY, Chau WW, Law SW, KM C. Mobility,
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Appendix 1.
Evidence-Based Amputee Rehabilitation Program Study Design

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Appendix 2.
Constructs/Systems Being Assessed for Each Amputee Mobility Predictor Task and Exercises Choice

Amputee Mobility Predictor Evidence-Based Amputee Rehabilitation Exercise Guidea

AMP Task Primary Construct/System Exercises

Task 1: Sitting balance, Trunk rhythmic rotation
Sitting balance trunk stability, Resisted trunk flexion & extension
sitting endurance Dynamic surface sitting exercise
Sitting endurance progression
Task 2: Sitting balance, Trunk rotations with cane
Sitting reach trunk/hip extensor strength Trunk rotations with heavy ball

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Dynamic surface trunk flexion & extension
Heavy ball catch and throw
Task 3: Dynamic balance, Organizational planning transfers
Chair to chair transfer upper/lower limb strength Seated prosthetic weight-bearing
Seated dips
Partial chair squats
Task 4: Dynamic balance, Organizational planning standing
Arise from a chair trunk/lower limb strength Seated forward weight shifts
Sit-to-stand progression
Partial to full wall squats
Task 5: Dynamic balance, Dynamic stump exercises
Attempts to arise from chair Trunk/lower limb strength Organizational planning standing
Dynamic surface trunk rotations with cane
Dynamic surface trunk flexion & extension
Task 6: Dynamic standing balance, Rhythmic stabilization in standing pelvis-trunk
Immediate standing balance postural stability Perturbation in standing: thighs-pelvis–trunk
Dynamic surface standing
Dynamic surface trunk rotations with cane
Task 7: Standing balance, Postural positioning and feedback with mirror
Standing balance postural stability, Frontal plane weight shift
muscular endurance Sagittal plane weight shifts
Diagonal weight shifts
Task 8: Single limb balance, Bridging
Single limb balance strength, endurance, Stool stepping
postural stability Single limb trunk rotations with cane
Ball rolls on prosthetic limb
Task 9: Standing balance, Perturbation in standing: rapid flexion/extension
Standing reach COM over BoS displacement, Sagittal plane weight shifts with arm swing
trunk extensor strength Standing heavy ball swings
Standing heavy ball throws
Task 10: Ankle, hip, Standing resisted trunk flexion
Nudged step strategies Rhythmic stabilization in standing
Standing rapid trunk perturbation
Standing heavy ball chest pass
Task 11: Possible Refer to vestibular specialist
Eyes closed vestibular/balance
impairment
Task 12: Dynamic balance, Bridging
Picking up object off floor postural extensor strength Squats
Lunges
Weighted ball lunges
Task 13: Dynamic balance, Organizational planning standing
Sitting down eccentric trunk, Seated forward weight shifts
lower limb strength Sit-to-stand progression
Partial to full wall squats

(Continued)

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Appendix 2.
Continued

AMP Task Primary Construct/System Exercises

Task 14: COM displacement over BoS, Level walking
Initiation of gait prosthetic gait control Multi-directional stepping
Stop and go walking
Ramp decline walking
Task 15: Single limb balance, Stool stepping
Step length & height range of motion, Restoration of pelvic transverse rotation
prosthetic weight-bearing, Resisted gait training
prosthetic gait control Ball rolls
Task 16: Single limb balance, Resisted gait training
Step continuity double support time, Lateral walking
prosthetic gait control Braiding
Stop and go walking
Task 17: Dynamic single limb balance, Restoration of pelvic transverse rotation
Turning lower limb strength Prosthetic turning progression
Braiding
Forward/lateral cup-walkingc
Task 18: Dynamic single limb balance, Stool stepping
Variable cadence prosthetic gait control, Restoration trunk rotation
dynamic postural stability Resisted walking, prosthetic foot late stance
Speed training: increased step frequency
Task 19: Dynamic single limb balance, Stool stepping
Stepping over an obstacle prosthetic gait control, Forward cup-walking
dynamic postural stability Obstacle course performance
Resisted elastic kicks
Task 20: Dynamic single limb balance, Prosthetic stair ascent progression
Ascending and descending lower limb strength, Prosthetic stair decent progression
stairs prosthetic control Wall squats
Lunges
a
Courtesy Advanced Rehabilitation Therapy, Inc. Miami, Florida Copyright © 2016. AMP = Amputee Mobility Predictor, BoS = base
of support; COM = center of mass.

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