Traumatic Amputation of Lower Extremity
Conditions
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.
Interventions
DEVICEFES
Sponsors
Alicia Koontz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System | baseline and 12 weeks | 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. |
| Change in Residual Limb Volume Using 3-D Scanner | baseline and 12 weeks | 3-D motion-tracking laser scanning system was used to determine residual limb volume in cm |
| Change in Residual Limb Pain Using Likert Scale Pain Questionnaire | baseline and 12 weeks | Scores were reported on a 0 to 10 scale with higher scores representing higher pain levels |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Control Participants will be asked to continue their activities of daily living as usual. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Control | Total | FES Intervention |
|---|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 16.8 | 52.8 years STANDARD_DEVIATION 13.9 | 55.7 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 20 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FES Intervention | Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System | -0.1 Nm/kg |
| Control | Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System | 2.2 Nm/kg |
p-value: 0.768Wilcoxon (Mann-Whitney)
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
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FES Intervention | Change in Residual Limb Pain Using Likert Scale Pain Questionnaire | -1.2 units on a scale |
| Control | Change in Residual Limb Pain Using Likert Scale Pain Questionnaire | 1.5 units on a scale |
p-value: 0.03Wilcoxon (Mann-Whitney)
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
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FES Intervention | Change in Residual Limb Volume Using 3-D Scanner | -1.6 cm |
| Control | Change in Residual Limb Volume Using 3-D Scanner | 23.9 cm |
p-value: 1Wilcoxon (Mann-Whitney)