An interventional study of FES in Traumatic Amputation of Lower Extremity, sponsored by Alicia Koontz. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Alicia Koontz · Not applicable, Interventional, and Treatment
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.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's enrollment of 20 is above the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.
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Exclusion Criteria:
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
Participants will be asked to continue their activities of daily living as usual.
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.
Time frame: 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
Time frame: 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
Time frame: baseline and 12 weeks
| Milestone | FES Intervention | Control |
|---|---|---|
| Started | 10 | 10 |
| Completed | 5 | 10 |
| Not completed | 5 | 0 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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.
| Nm/kg | FES Intervention | Control |
|---|---|---|
| Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System | -0.1 (-6.0 to 5.7) | 2.2 (-1.4 to 5.8) |
3-D motion-tracking laser scanning system was used to determine residual limb volume in cm
| cm | FES Intervention | Control |
|---|---|---|
| Change in Residual Limb Volume Using 3-D Scanner | -1.6 (-13.9 to 10.7) | 23.9 (-39.8 to 87.6) |
Scores were reported on a 0 to 10 scale with higher scores representing higher pain levels
| units on a scale | FES Intervention | Control |
|---|---|---|
| Change in Residual Limb Pain Using Likert Scale Pain Questionnaire | -1.2 (-2.8 to 0.4) | 1.5 (-0.6 to 3.6) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FES Intervention | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Control | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | FES Intervention | Control | Total |
|---|---|---|---|
| Mean | 55.7 ± 10.4 | 49.9 ± 16.8 | 52.8 ± 13.9 |
| Sex: Female, Male(Participants) | FES Intervention | Control | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 7 | 8 | 15 |
| Ethnicity (NIH/OMB)(Participants) | FES Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 10 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | FES Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 9 | 8 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Alicia Koontz