NCT07532499

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

April 30, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

April 6, 2026

Last Update Submit

April 13, 2026

Conditions

Peripheral Nerve InjuriesMedian Nerve InjuryUlnar Nerve Injury

Keywords

peripheral nerve injuriesEMG-triggered electrical stimulationphysiotherapyfunctional recovery

Outcome Measures

Primary Outcomes (1)

  • Manual muscle test

    At 12 and 24 weeks after surgery.

Secondary Outcomes (2)

  • Gross and fine grip strength measurements by hand dynamometry and pinch gauge (kg)

    At 12 and 24 weeks after surgery.

  • Assessment of hand function via Michigan Hand Outcomes Questionnaire

    At 12 and 24 weeks after surgery

Study Arms (2)

EMG-triggered electrical stimulation group

EXPERIMENTAL
Other: EMG-triggered electrical stimulation

Conventional physiotherapy group

ACTIVE COMPARATOR
Other: Conventional physiotherapy group

Interventions

EMG-triggered electrical stimulationOTHER

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.

EMG-triggered electrical stimulation group
Conventional physiotherapy groupOTHER

The conventional physiotherapy program will comprise splinting, edema control, range of motion exercises, and resistance training.

Conventional physiotherapy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intact communication skills
  • No prior history of neurological, orthopedic, rheumatologic, or metabolic diseases affecting the involved extremity

You may not qualify if:

  • Presence of concomitant central nervous system involvement
  • Pregnancy
  • Patients with cardiac pacemakers
  • Patients with cardiac arrhythmias
  • Patients with epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Umut Eraslan

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Umut Eraslan

CONTACT

+905444126520ueraslan@pau.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 16, 2026

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04