Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Participants will be asked to continue their activities of daily living as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FES | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41082674 | Derived | Peterson SL, Wang H, Miknevich MA, Piva SR, Cooper RA, Koontz AM. Feasibility and Preliminary Efficacy of Neuromuscular Electrical Stimulation in A Pilot Randomized Control Trial in Individuals With Transtibial Amputations. Am J Phys Med Rehabil. 2026 Apr 1;105(4):312-320. doi: 10.1097/PHM.0000000000002874. Epub 2025 Sep 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. FES |
| FG001 | Control | Participants will be asked to continue their activities of daily living as usual. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. FES |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | Nm/kg | baseline and 12 weeks |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. FES |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alicia Koontz | University of Pittsburgh | 4128223700 | akoontz@pitt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2018 | Jan 30, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| BG001 | Control | Participants will be asked to continue their activities of daily living as usual. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Control | Participants will be asked to continue their activities of daily living as usual. |
|
|
|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | cm | baseline and 12 weeks |
|
|
|
|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and 12 weeks |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control | Participants will be asked to continue their activities of daily living as usual. | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided