- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07532499
EMG-Triggered Electrical Stimulation After Median/Ulnar Nerve Repairs
April 13, 2026 updated by: UMUT ERASLAN, Pamukkale University
The Impact of EMG-Triggered Electrical Stimulation of Extensor Muscles on Functional Status Following Median and/or Ulnar Nerve Repairs: A Single-Blind, Randomized Controlled Study
Immobilization following median and/or ulnar nerve repairs results in strength loss in the wrist and finger extensor muscles.
Given the critical importance of wrist extension for functional grip, this condition significantly restricts hand functions.
Therefore, this study aims to investigate the effects of EMG-triggered electrical stimulation applied to the wrist and finger extensors, in addition to conventional physiotherapy, on functional outcomes in patients undergoing median and/or ulnar nerve repair, with the objective of restoring extensor muscle weakness induced by immobilization.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Umut Eraslan
- Phone Number: +905444126520
- Email: ueraslan@pau.edu.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Intact communication skills
- No prior history of neurological, orthopedic, rheumatologic, or metabolic diseases affecting the involved extremity
Exclusion Criteria:
- Presence of concomitant central nervous system involvement
- Pregnancy
- Patients with cardiac pacemakers
- Patients with cardiac arrhythmias
- Patients with epilepsy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMG-triggered electrical stimulation group
|
This group will receive EMG-triggered electrical stimulation therapy in addition to conventional physiotherapy in the 5th week.The EMG-triggered electrical stimulation protocol will be conducted over 12 sessions (3 days/week for 4 weeks).
Surface electrodes will be placed parallel to the fibers of the wrist and finger extensors-specifically the EDC, ECRL/B, and ECU-using anatomical landmarks and palpation.
Following a baseline calibration (5s contraction/10s rest) to establish a microvolt threshold, the device will require active cognitive participation from the patient to initiate stimulation.
Once the threshold is exceeded, stimulation will be delivered at 60 Hz with a 300 µS pulse width and 0.5s ramp times.
The procedure involves 10 repetitions per muscle, utilizing a 10s contraction and 30s rest cycle to enhance functional recovery.
|
|
Active Comparator: Conventional physiotherapy group
|
The conventional physiotherapy program will comprise splinting, edema control, range of motion exercises, and resistance training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Manual muscle test
Time Frame: At 12 and 24 weeks after surgery.
|
At 12 and 24 weeks after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross and fine grip strength measurements by hand dynamometry and pinch gauge (kg)
Time Frame: At 12 and 24 weeks after surgery.
|
At 12 and 24 weeks after surgery.
|
|
|
Assessment of hand function via Michigan Hand Outcomes Questionnaire
Time Frame: At 12 and 24 weeks after surgery
|
The score for each domain and the total score range from min 0 to max 100.
For all domains except pain, a higher score denotes better hand performance or satisfaction.
For the pain domain, a higher score indicates more pain.
|
At 12 and 24 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Umut Eraslan, Pamukkale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Baldwin ERL, Klakowicz PM, Collins DF. Wide-pulse-width, high-frequency neuromuscular stimulation: implications for functional electrical stimulation. Journal of Applied Physiology 2006;101(1):228-240.
- Shin HK, Cho SH, Jeon H, et al. Cortical effect and functional recovery by the electromyography-triggered neuromuscular stimulation in chronic stroke patients. Neuroscience Letters 2008;442(3):174-179.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 30, 2026
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
November 30, 2027
Study Registration Dates
First Submitted
April 6, 2026
First Submitted That Met QC Criteria
April 13, 2026
First Posted (Actual)
April 16, 2026
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 13, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-60116787-020-849492
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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