Clinical Trial: Functional Electrical Stimulation Use in Trans-tibial Amputations

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Functional Electrical Stimulation Use in Trans-tibial Amputations

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Pittsburgh

Current Primary Outcome:

  • Change in knee extension strength (peak torque) using the Biodex Measurement System [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 3 months ]
    Biodex Isokinetic measurement system
  • Change in residual limb volume using 3-D scanner [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 3 months ]
    3-D motion-tracking laser scanning system
  • Change in residual limb pain using likert scale pain questionnaire [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 3 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Pittsburgh

Dates:
Date Received: January 25, 2016
Date Started: September 2015
Date Completion: January 2018
Last Updated: May 2, 2017
Last Verified: May 2017