Status:
COMPLETED
Evidence Based Amputee Rehabilitation (EBAR) Program
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Amputation Stumps
Diabetes Mellitus
Eligibility:
All Genders
40-80 years
Phase:
NA
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 stan...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00126126
Start Date
January 1 2005
End Date
May 1 2008
Last Update
October 20 2015
Active Locations (1)
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1
VA Medical Center, Miami
Miami, Florida, United States, 33125