Traumatic Amputation of Lower Extremity Clinical Trial
Official title:
Functional Electrical Stimulation Use in Trans-tibial Amputations
The purpose of this study is to demonstrate the efficacy of functional electrical stimulation (FES) for trans-tibial amputees. The investigators aim to demonstrate that providing three months of FES intervention will increase knee extension strength, increase volume of the residual limb and decrease chronic and phantom pain.
SUMMARY STUDY GOALS: The purpose of this study is to demonstrate the efficacy of FES for
trans-tibial amputees. The investigators aim to demonstrate that providing three months of
FES intervention will increase knee extension strength, increase volume of the residual limb
and decrease chronic and phantom pain.
EXPERIMENTAL DESIGN: Randomized control trial METHODS: Twenty participants will be recruited
and randomly divided into two groups, one group will receive the FES intervention while the
other group will continue with activities of daily living. Both groups will keep a daily log
of number of hours the prosthesis is worn, number of hours the FES is worn (if used) and any
changes in skin conditions or medications. Both groups will return for assessment visits at
4, 8, and 12 weeks and a follow up visit 3 months post-intervention for investigators to
inspect the residual limb and check the fit of the prosthetic socket, record residual limb
knee extension strength on the Biodex machine, take measurements (circumferences and lengths)
of the residual limb with a tape measure and ruler, scan the limb with the hand held
three-dimensional motion-tracking laser scanner system and the participant will be asked to
complete a pain questionnaire. The Prosthetic Evaluation Questionnaire (PEQ) will be
completed at the 12 week and the 3 month follow-up visits. Although outcomes data were
captured during each assessment visit (0, 4, 8 and 12 weeks and 3 months), changes in the
primary outcomes (strength, volume and pain) at timepoints 0 weeks (pre-intervention) and 12
weeks (post- intervention) were of primary interest.
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