Amputation Stumps, Diabetes Mellitus
Conditions
Keywords
Artificial Limbs, Evidence based medicine, Exercise, Outcomes research, Physical therapy
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.
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.
Interventions
OTHEREBAR Program
Evidence Based Amputee Rehabilitation Program
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
Twenty individuals who met inclusion criteria completed the consent process. Eighteen were randomized to either intervention (n = 9) or wait list control (n = 9).
Participants by arm
| Arm | Count |
|---|---|
| Intervention Those subjects who were randomized to receive the Evidence Based Amputee Rehabilitation (EBAR) Program | 9 |
| Wait List Control Group Those subjects who were randomized to the wait-list control group. | 7 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Wait List Control Group | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Continuous | 63.0 years STANDARD_DEVIATION 7.1 | 63.4 years STANDARD_DEVIATION 11.4 | 63.3 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 7 participants | 9 participants | 16 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 7 |
| serious Total, serious adverse events | 0 / 9 | 0 / 7 |
Outcome results
Primary
Amputee Mobility Predictor
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
Population: Repeated Measures ANOVA
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Amputee Mobility Predictor | Pre-Intervention | 36.4 Points | Standard Deviation 4 |
| Intervention | Amputee Mobility Predictor | Post-Intervention | 41.7 Points | Standard Deviation 4 |
| Wait-List Control Group | Amputee Mobility Predictor | Pre-Intervention | 35.3 Points | Standard Deviation 2.4 |
| Wait-List Control Group | Amputee Mobility Predictor | Post-Intervention | 35.6 Points | Standard Deviation 5.4 |
Secondary
Six-minute Walk Test
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
Population: Repeated Measures ANOVA
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Six-minute Walk Test | Pre-Intervention | 313.6 meters | Standard Deviation 138.9 |
| Intervention | Six-minute Walk Test | Post-Intervention | 387.7 meters | Standard Deviation 130.6 |
| Wait-List Control Group | Six-minute Walk Test | Pre-Intervention | 262.6 meters | Standard Deviation 132.4 |
| Wait-List Control Group | Six-minute Walk Test | Post-Intervention | 268.8 meters | Standard Deviation 157.4 |