Functional Electrical Stimulation Use in Trans-tibial Amputations

NCT02931396 | Completed Results

• 1 other identifier: PRO14050193
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Amputation of Lower Extremity

Outcome Measures

Primary Outcomes (3)

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

  Residual limb knee extension isometric strength was tested using a standardized Biodex protocol and custom attachment. The lever arm of the Biodex was positioned at 60 degrees of knee flexion, with the support cushion modified for the amputee and positioned at the mid-tibia. The participant was asked to extend their knee against the arm as hard as they could for five seconds.

  baseline and 12 weeks

• Change in Residual Limb Volume Using 3-D Scanner

  3-D motion-tracking laser scanning system was used to determine residual limb volume in cm

  baseline and 12 weeks

• Change in Residual Limb Pain Using Likert Scale Pain Questionnaire

  Scores were reported on a 0 to 10 scale with higher scores representing higher pain levels

  baseline and 12 weeks

Study Arms (2)

FES intervention

EXPERIMENTAL

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.

Device: FES

Control

NO INTERVENTION

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

Interventions

FES DEVICE

FES intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No cardiac conditions, such as hypertension, congestive heart failure, or a pacemaker.
• People with severe diabetes who have insensate skin and or neuropathy.

Sponsors & Collaborators

• Alicia Koontz: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

Results Point of Contact

• Title: Alicia Koontz
• Organization: University of Pittsburgh

akoontz@pitt.edu

4128223700

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: October 13, 2016
• Study Start: September 1, 2015
• Primary Completion: February 3, 2018
• Study Completion: February 3, 2018
• Last Updated: December 2, 2024
• Results First Posted: March 21, 2019

Record last verified: 2024-11

Locations

US (1)