Evidence Based Amputee Rehabilitation (EBAR) Program

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00126126
First received: August 1, 2005
Last updated: June 19, 2008
Last verified: June 2008

August 1, 2005
June 19, 2008
January 2005
May 2008   (final data collection date for primary outcome measure)
AMP, 6MWT [ Time Frame: 8 weeks for intervention, 16 weeks for wait list control group ] [ Designated as safety issue: No ]
  • AAS and Six-minute Walk Test,AMPPro and AMPnoPro.
  • Every 6th session,intervention group will perform a six-minute walk test, AMPPro and complete the AAS questionnaire.
  • At the end of 8 weeks subjects in both the intervention and wait list control group will undergo follow-up testing by an examiner who is blinded to group assignment.
  • Follow-up testing will include the six minute walk test, AAS, AMPro and AMPPnpPro
Complete list of historical versions of study NCT00126126 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evidence Based Amputee Rehabilitation (EBAR) Program
Evidence Based Amputee Rehabilitation (EBAR) Program

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Amputation
  • Diabetes Mellitus
Behavioral: Exercise
1
Intervention: Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00126126
A3381R, 3019.01
Yes
Gaily, Robert - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Robert Gaily, PhD PT VA Medical Center, Miami
Department of Veterans Affairs
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP