EMG-Triggered Electrical Stimulation After Median/Ulnar Nerve Repairs
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Umut Eraslan
- Phone Number: +905444126520
- Email: ueraslan@pau.edu.tr
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Umut Eraslan, Pamukkale University
Publications and helpful links
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
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- E-60116787-020-849492
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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