Evidence Based Amputee Rehabilitation (EBAR) Program
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if an evidence based exercise intervention improves the functional mobility of diabetic amputees (single lower leg amputation) who have already completed standard rehabilitation and prosthetic training.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Subjects who pass all eligibility requirements will then undergo baseline testing by an examiner who will remain blinded to subject group assignment. Baseline testing will include the AAS, six-minute walk test, and both the AMPPro and AMPnoPro.
After baseline testing has been completed, subjects will be randomly assigned to either the intervention or wait list control. Randomization will occur in blocks of 20 such that for each panel of 20 subjects, 50% will be randomized to the intervention and 50% will be randomized to wait list control. Randomization will be performed using a random-number table to assign treatment group to status to each subject's unique identification number. Randomization status will be concealed by recording status on a card that is folded in half so that the group assignment is inside the fold. The cards will be placed in envelopes bearing identification numbers. When a subject has completed all baseline measures, the envelope with that subject's ID number will be opened and the subject will be assigned to a group.
Subjects assigned to the intervention group will undergo clinical strength testing. An individualized program will be developed for each subject based on his or her AMP test results and clinical strength testing. Subjects will then attend rehabilitation sessions 3 times per week for 8 weeks. Each session will last approximately 45 minutes including any required rest periods. Subjects will perform endurance, balance and strengthening exercises at each session. Every 6th session, subjects in the intervention group will perform a six-minute walk test, AMPPro and complete the AAS questionnaire. The results of each AMPPro test will be reviewed and the therapeutic exercise program revised according.
After follow-up testing, subjects assigned to the wait list condition will be eligible to attend the 8-week rehabilitation program. Wait list subjects in the exercise phase will also receive the same exercise intervention described above. They will also perform a six-minute walk test, AMPPro and complete the AAS questionnaire every 6th session.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EBAR Program Evidence Based Amputee Rehabilitation Program (rehabilitation program based on performance of the Amputee Mobility Predictor |
Other: EBAR Program
Evidence Based Amputee Rehabilitation Program
|
| No Intervention: Wait List Control Wait List Control Group |
Outcome Measures
Primary Outcome Measures
- Amputee Mobility Predictor [8 weeks for intervention and for wait-list control]
The Amputee Mobility Predictor is a reliable and valid performance-based outcome measure of prosthetic mobility. The AMP is scored from 0-47, higher scores indicating greater prosthetic mobility. The AMP can help clinicians differentiate between different functional K-levels based on as defined by the Medicare Functional Classification Level (MFCL) system. Lower limb amputees functioning at the K2 level score between 27-36 on the AMP and are classified as limited community ambulators. Those at the K3 level score between 37-42 and are typical community ambulators who have the ability to traverse environmental barriers and performing activities that are beyond simple locomotion. Individuals at the K4 level score between 43-47 which is typical of prosthetic demands of an active adult or regular athlete. The minimal detectable change for the AMP is 3.4 points.
Secondary Outcome Measures
- Six-minute Walk Test [8 weeks for intervention and wait list control group]
The six-minute walk test (6MWT) is a measure of overall functional mobility, and cardiopulmonary and musculoskeletal endurance. It assesses the distance ambulated in 6 minutes. The 6MWT has excellent reliability for lower limb amputees and can differentiate between amputee Medicare Functional Classification Levels (MFCL).Lower limb amputees functioning at the K2 level ambulate a mean distance of 200 meters. Those at the K3 level ambulate a mean distance of 300 meters. Those at the K4 level ambulate a mean distance of 400 meters. Service Members with traumatic lower limb loss ambulate a distance of 600 meters. The minimal detectable change for the 6MWT is 45 meters.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
People with unilateral transtibial amputations (TTA)
-
At the lowest level of function candidates will have the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at a fixed cadence. Typical of the limited and unlimited household ambulator, the majority of candidates' ability or potential for ambulation with the ability to transverse low-level environmental barriers such as curbs, stairs, or uneven surfaces (the ceiling for candidacy) will be those TTAs who have the ability to vary cadence and can ambulate within the community.
-
People with a diagnosis of diabetic mellitus and/or peripheral vascular disease leading to amputation
-
Persons comfortably fitted with a prosthesis for a period of at least 6 months
-
Candidates who have completed the "standard" course of rehabilitation and prosthetic training
-
Candidates who score in the range of 10 to 36 on the Amputee Mobility Predictor which would indicate that subjects achieved the minimum required score to be fitted with a prosthesis but they did not attain a score that is considered to be at the highest level of functioning where additional therapy would not be of significant benefit.
-
Able to tolerate a moderate intensity exercise program
Exclusion Criteria:
-
Persons receiving renal dialysis
-
Persons with severe cardiac or pulmonary disease limiting ability to exercise including angina or poorly controlled hypertension.
-
Persons with neurological disorders such as Parkinson's disease or stroke that affect ability to ambulate
-
Persons with severe lower extremity arthritis
-
Persons with wound on non-amputated side
-
Persons experiencing problems with prosthetic fit
-
Persons with poor control of diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Medical Center, Miami | Miami | Florida | United States | 33125 |
Sponsors and Collaborators
- US Department of Veterans Affairs
Investigators
- Principal Investigator: Robert Gailey, PhD, PT, Miami Veterans Affairs Healthcare System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A3381-R
- 3019.01
Study Results
Participant Flow
| Recruitment Details | Three hundred twenty six Individuals with unilateral lower limb loss were screened. Twenty agreed to participate in the study and completed the consent process. |
|---|---|
| Pre-assignment Detail | Twenty individuals who met inclusion criteria completed the consent process. Eighteen were randomized to either intervention (n = 9) or wait list control (n = 9). |
| Arm/Group Title | Intervention | Wait-List Control Group |
|---|---|---|
| Arm/Group Description | Evidence Based Amputee Rehabilitation Program Exercise: Evidence Based Amputee Rehabilitation Program | These individuals waited 8 weeks in order to begin the intervention. |
| Period Title: Overall Study | ||
| STARTED | 9 | 9 |
| COMPLETED | 9 | 7 |
| NOT COMPLETED | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Intervention | Wait List Control Group | Total |
|---|---|---|---|
| Arm/Group Description | Those subjects who were randomized to receive the Evidence Based Amputee Rehabilitation (EBAR) Program | Those subjects who were randomized to the wait-list control group. | Total of all reporting groups |
| Overall Participants | 9 | 7 | 16 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
6
66.7%
|
6
85.7%
|
12
75%
|
| >=65 years |
3
33.3%
|
1
14.3%
|
4
25%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
63.4
(11.4)
|
63.0
(7.1)
|
63.3
(9.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
33.3%
|
0
0%
|
3
18.8%
|
| Male |
6
66.7%
|
7
100%
|
13
81.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
9
100%
|
7
100%
|
16
100%
|
Outcome Measures
| Title | Amputee Mobility Predictor |
|---|---|
| Description | The Amputee Mobility Predictor is a reliable and valid performance-based outcome measure of prosthetic mobility. The AMP is scored from 0-47, higher scores indicating greater prosthetic mobility. The AMP can help clinicians differentiate between different functional K-levels based on as defined by the Medicare Functional Classification Level (MFCL) system. Lower limb amputees functioning at the K2 level score between 27-36 on the AMP and are classified as limited community ambulators. Those at the K3 level score between 37-42 and are typical community ambulators who have the ability to traverse environmental barriers and performing activities that are beyond simple locomotion. Individuals at the K4 level score between 43-47 which is typical of prosthetic demands of an active adult or regular athlete. The minimal detectable change for the AMP is 3.4 points. |
| Time Frame | 8 weeks for intervention and for wait-list control |
Outcome Measure Data
| Analysis Population Description |
|---|
| Repeated Measures ANOVA |
| Arm/Group Title | Intervention | Wait-List Control Group |
|---|---|---|
| Arm/Group Description | Evidence Based Amputee Rehabilitation Program Exercise: Evidence Based Amputee Rehabilitation Program | These individuals waited 8 weeks in order to begin the intervention. |
| Measure Participants | 9 | 7 |
| Pre-Intervention |
36.4
(4.0)
|
35.3
(2.4)
|
| Post-Intervention |
41.7
(4.0)
|
35.6
(5.4)
|
| Title | Six-minute Walk Test |
|---|---|
| Description | The six-minute walk test (6MWT) is a measure of overall functional mobility, and cardiopulmonary and musculoskeletal endurance. It assesses the distance ambulated in 6 minutes. The 6MWT has excellent reliability for lower limb amputees and can differentiate between amputee Medicare Functional Classification Levels (MFCL).Lower limb amputees functioning at the K2 level ambulate a mean distance of 200 meters. Those at the K3 level ambulate a mean distance of 300 meters. Those at the K4 level ambulate a mean distance of 400 meters. Service Members with traumatic lower limb loss ambulate a distance of 600 meters. The minimal detectable change for the 6MWT is 45 meters. |
| Time Frame | 8 weeks for intervention and wait list control group |
Outcome Measure Data
| Analysis Population Description |
|---|
| Repeated Measures ANOVA |
| Arm/Group Title | Intervention | Wait-List Control Group |
|---|---|---|
| Arm/Group Description | Evidence Based Amputee Rehabilitation Program Exercise: Evidence Based Amputee Rehabilitation Program | These individuals waited 8 weeks in order to begin the intervention. |
| Measure Participants | 9 | 7 |
| Pre-Intervention |
313.6
(138.9)
|
262.6
(132.4)
|
| Post-Intervention |
387.7
(130.6)
|
268.8
(157.4)
|
Adverse Events
| Time Frame | 3 years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Intervention | Wait-List Control Group | ||
| Arm/Group Description | Evidence Based Amputee Rehabilitation Program Exercise: Evidence Based Amputee Rehabilitation Program | These individuals waited 8 weeks in order to begin the intervention. | ||
All Cause Mortality |
||||
| Intervention | Wait-List Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Intervention | Wait-List Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/7 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Intervention | Wait-List Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/7 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Robert Gailey, PhD, PT |
|---|---|
| Organization | Miami VAHS & University of Miami, Department of PT |
| Phone | 305-284-4535 |
| rgailey@miami.edu |
- A3381-R
- 3019.01