Traumatic Amputation of Lower ExtremityNCT02931396
Functional Electrical Stimulation Use in Trans-tibial Amputations
A study testing FES in people with Traumatic Amputation of Lower Extremity, run by Alicia Koontz at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Amputation of Lower Extremity
- What is being tested?
- FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 3 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No cardiac conditions, such as hypertension, congestive heart failure, or a pacemaker.
- People with severe diabetes who have insensate skin and or neuropathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15206
About this study
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.
Read the 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.
- Conditions
- Traumatic Amputation of Lower Extremity
- Being tested
- FES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FESDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FES |
| Control | No intervention | Participants will be asked to continue their activities of daily living as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startSep 2015
- Primary completion3 Feb 2018
- Study completion3 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Amputation of Lower ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alicia Koontz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alicia Koontz, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931396
- Sponsor's protocol ID
- PRO14050193
- Status last verified
- Nov 2024
- First submitted
- 25 Jan 2016
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 41082674
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation Use in Trans-tibial Amputations
- ClinicalTrials.gov ID
- NCT02931396
- Acronym / sponsor ID
- PRO14050193
- Conditions
- Traumatic Amputation of Lower Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alicia KoontzUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 3 Feb 2018 (actual)
- Study completion
- 3 Feb 2018 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Posted 21 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES intervention | Experimental | Device: FESStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- No cardiac conditions, such as hypertension, congestive heart failure, or a pacemaker.
- People with severe diabetes who have insensate skin and or neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FES | Device | FES intervention |
Primary outcome
Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System
Time frame: 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
Time frame: 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
Time frame: baseline and 12 weeks
Scores were reported on a 0 to 10 scale with higher scores representing higher pain levels
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41082674Peterson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES in people with Traumatic Amputation of Lower Extremity, run by Alicia Koontz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System (time frame: baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02931396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.