Diabetes Mellitus Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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