Evidence Based Amputee Rehabilitation (EBAR) Program

Completed · Not applicable

Conditions studied: Amputation Stumps, Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00126126

Run by

US Department of Veterans Affairs

People needed

20

Starts

2005-01-01

Expected to finish

2008-05-01

Last updated by the study team

2015-10-20

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Medical Center, Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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