CompletedNot Applicable

Functional Electrical Stimulation Use in Trans-tibial Amputations

United States20 participantsStarted 2015-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women over 18 years of age. * Participants have a unilateral trans-tibial amputation with a minimum of a 4" residual limb. This length of amputation was chosen to provide for adequate surface area for the electrodes. * Participants must be a minimum of two years postoperative to insure proper healing of the limb has occurred. * Participants have chronic limb pain. * No prior experience in using TENS or FES. Exclusion Criteria: * No cardiac conditions, such as hypertension, congestive heart failure, or a pacemaker. * People with severe diabetes who have insensate skin and or neuropathy.

What they're measuring

Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System

Timeframe: baseline and 12 weeks

Change in Residual Limb Volume Using 3-D Scanner

Timeframe: baseline and 12 weeks

Change in Residual Limb Pain Using Likert Scale Pain Questionnaire

Timeframe: baseline and 12 weeks

Trial details

NCT IDNCT02931396

SponsorAlicia Koontz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02-03

Results submitted2019-01-30

View on ClinicalTrials.gov More Traumatic Amputation of Lower Extremity trials