Evidence Based Amputee Rehabilitation (EBAR) Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00126126
First received: August 1, 2005
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Amputation
Diabetes Mellitus
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evidence Based Amputee Rehabilitation (EBAR) Program

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • AMP, 6MWT [ Time Frame: 8 weeks for intervention, 16 weeks for wait list control group ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Evidence Based Amputee Rehabilitation Program
Behavioral: Exercise
Evidence Based Amputee Rehabilitation Program

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126126

Locations
United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00126126     History of Changes
Other Study ID Numbers: A3381-R, 3019.01
Study First Received: August 1, 2005
Last Updated: October 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Artificial Limbs
Evidence based medicine
Exercise
Outcomes research
Physical therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014