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Evidence Based Amputee Rehabilitation (EBAR) Program (EBAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00126126
Recruitment Status : Completed
First Posted : August 2, 2005
Results First Posted : October 20, 2015
Last Update Posted : October 20, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Amputation Stumps Diabetes Mellitus Other: EBAR 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evidence Based Amputee Rehabilitation (EBAR) Program
Study Start Date : January 2005
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: EBAR Program
Evidence Based Amputee Rehabilitation Program (rehabilitation program based on performance of the Amputee Mobility Predictor
Other: EBAR Program
Evidence Based Amputee Rehabilitation Program
No Intervention: Wait List Control
Wait List Control Group

Outcome Measures

Primary Outcome Measures :
  1. Amputee Mobility Predictor [ Time Frame: 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 Outcome Measures :
  1. Six-minute Walk Test [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126126

United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Robert Gailey, PhD, PT Miami Veterans Affairs Healthcare System
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00126126     History of Changes
Other Study ID Numbers: A3381-R
3019.01 ( Registry Identifier: Miami VA IRB )
First Posted: August 2, 2005    Key Record Dates
Results First Posted: October 20, 2015
Last Update Posted: October 20, 2015
Last Verified: September 2015

Keywords provided by VA Office of Research and Development:
Artificial Limbs
Evidence based medicine
Outcomes research
Physical therapy

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