Trial Outcomes & Findings for Evidence Based Amputee Rehabilitation (EBAR) Program (NCT NCT00126126)
NCT ID: NCT00126126
Last Updated: 2015-10-20
Results Overview
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.
COMPLETED
NA
20 participants
8 weeks for intervention and for wait-list control
2015-10-20
Participant Flow
Three hundred twenty six Individuals with unilateral lower limb loss were screened. Twenty agreed to participate in the study and completed the consent process.
Twenty individuals who met inclusion criteria completed the consent process. Eighteen were randomized to either intervention (n = 9) or wait list control (n = 9).
Participant milestones
| Measure |
Intervention
Evidence Based Amputee Rehabilitation Program
Exercise: Evidence Based Amputee Rehabilitation Program
|
Wait-List Control Group
These individuals waited 8 weeks in order to begin the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Intervention
Evidence Based Amputee Rehabilitation Program
Exercise: Evidence Based Amputee Rehabilitation Program
|
Wait-List Control Group
These individuals waited 8 weeks in order to begin the intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Evidence Based Amputee Rehabilitation (EBAR) Program
Baseline characteristics by cohort
| Measure |
Intervention
n=9 Participants
Those subjects who were randomized to receive the Evidence Based Amputee Rehabilitation (EBAR) Program
|
Wait List Control Group
n=7 Participants
Those subjects who were randomized to the wait-list control group.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
63.0 years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
63.3 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
7 participants
n=107 Participants
|
16 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeks for intervention and for wait-list controlPopulation: Repeated Measures ANOVA
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.
Outcome measures
| Measure |
Intervention
n=9 Participants
Evidence Based Amputee Rehabilitation Program
Exercise: Evidence Based Amputee Rehabilitation Program
|
Wait-List Control Group
n=7 Participants
These individuals waited 8 weeks in order to begin the intervention.
|
|---|---|---|
|
Amputee Mobility Predictor
Pre-Intervention
|
36.4 Points
Standard Deviation 4.0
|
35.3 Points
Standard Deviation 2.4
|
|
Amputee Mobility Predictor
Post-Intervention
|
41.7 Points
Standard Deviation 4.0
|
35.6 Points
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 8 weeks for intervention and wait list control groupPopulation: Repeated Measures ANOVA
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.
Outcome measures
| Measure |
Intervention
n=9 Participants
Evidence Based Amputee Rehabilitation Program
Exercise: Evidence Based Amputee Rehabilitation Program
|
Wait-List Control Group
n=7 Participants
These individuals waited 8 weeks in order to begin the intervention.
|
|---|---|---|
|
Six-minute Walk Test
Pre-Intervention
|
313.6 meters
Standard Deviation 138.9
|
262.6 meters
Standard Deviation 132.4
|
|
Six-minute Walk Test
Post-Intervention
|
387.7 meters
Standard Deviation 130.6
|
268.8 meters
Standard Deviation 157.4
|
Adverse Events
Intervention
Wait-List Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Gailey, PhD, PT
Miami VAHS & University of Miami, Department of PT
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place