Functional Electrical Stimulation Use in Trans-tibial Amputations

NCT ID: NCT02931396

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-02-03

Brief 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.

Detailed Description

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.

Conditions

Traumatic Amputation of Lower Extremity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FES intervention

Study participants who are randomized into the intervention group will be fitted with a portable commercially available surface FES device and instructed in its use by a study investigator. Participants will be directed to use the FES 30 minutes a day for the first week, one hour a day during the next week, 90 minutes a day during the third week, and then a minimum of 2 hours per day or 10 hours per week for the next three months at home.

Group Type: EXPERIMENTAL

FES

Intervention Type: DEVICE

Control

Participants will be asked to continue their activities of daily living as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FES

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alicia Koontz

OTHER

Sponsor Role: lead

Responsible Party

Alicia Koontz

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO14050193

Identifier Type: -

Identifier Source: org_study_id