Clinical trial NCT00126126: Evidence Based Amputee Rehabilitation (EBAR) Program
Official title: Evidence Based Amputee Rehabilitation (EBAR) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation Stumps
Diabetes Mellitus
Keywords: Artificial Limbs
Evidence based medicine
Exercise
Outcomes research
Physical therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Amputee Mobility Predictor
timeFrame: 8 weeks for intervention and for wait-list control
Secondary outcomes:
measure: Six-minute Walk Test
timeFrame: 8 weeks for intervention and wait list control group
Other outcomes:
Locations:
city: Miami
country: United States
facility: VA Medical Center, Miami
state: Florida
Study officials:
affiliation: Miami Veterans Affairs Healthcare System
name: Robert Gailey, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gailey RS, Roach KE, Applegate EB, Cho B, Cunniffe B, Licht S, Maguire M, Nash MS. The amputee mobility predictor: an instrument to assess determinants of the lower-limb amputee's ability to ambulate. Arch Phys Med Rehabil. 2002 May;83(5):613-27. doi: 10.1053/apmr.2002.32309.
citation: Gailey RS, Scoville C, Gaunaurd IA, Raya MA, Linberg AA, Stoneman PD, Campbell SM, Roach KE. Construct validity of Comprehensive High-Level Activity Mobility Predictor (CHAMP) for male servicemembers with traumatic lower-limb loss. J Rehabil Res Dev. 2013;50(7):919-30. doi: 10.1682/JRRD.2012.05.0100.
citation: Resnik L, Borgia M. Reliability of outcome measures for people with lower-limb amputations: distinguishing true change from statistical error. Phys Ther. 2011 Apr;91(4):555-65. doi: 10.2522/ptj.20100287. Epub 2011 Feb 10.
citation: Gailey R, Gaunaurd I, Raya M, Kirk-Sanchez N, Prieto-Sanchez LM, Roach K. Effectiveness of an Evidence-Based Amputee Rehabilitation Program: A Pilot Randomized Controlled Trial. Phys Ther. 2020 May 18;100(5):773-787. doi: 10.1093/ptj/pzaa008.