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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

8 weeks for intervention and for wait-list control

Results posted on

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

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

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

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 control

Population: 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

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 group

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Wait-List Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 305-284-4535

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place