N/A
Completed N=20
Functional Electrical Stimulation Use in Trans-tibial Amputations
Traumatic Amputation of Lower Extremity
Source: ClinicalTrials.gov NCT02931396 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System — -0.1; 2.2 Nm/kg — p=0.768
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System |
-0.1; 2.2 | 0.768 |
| PRIMARY Change in Residual Limb Volume Using 3-D Scanner |
-1.6; 23.9 | 1 |
| PRIMARY Change in Residual Limb Pain Using Likert Scale Pain Questionnaire |
-1.2; 1.5 | 0.03 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02931396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.