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Functional Electrical Stimulation (FES) and Reconstructive Tetraplegia Hand and Arm Surgery

NCT03048331 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-11-26

No results posted yet for this study

Summary

FES is a common and established method in the rehabilitation of persons with spinal cord injury (SCI). Some known effects of FES were investigated in several studies e.g. avoiding disuse and denervation atrophy, improving muscle force, power output and endurance changing muscle fibre type, increasing cross sectional area of muscle, increasing muscle mass, activation of nerve sprouting, reducing spasticity and motor learning.

Most of the studies investigated the impact of FES in the lower limbs. For the upper extremities fewer studies exist. However, it is supposed that the effects of FES are similar.

In the rehabilitation of persons with tetraplegia, FES, especially the stimulation of the upper extremities triggered by electromyography (EMG) is an established method to generally improve hand and arm function. However, none of those studies has investigated the effect of FES in combination with reconstructive tetraplegia hand surgery. Improved muscle strength is supposed to improve the functional outcome in participation. Additionally, FES could increase the motor learning process. Supported by the clinical observation we hypothesize that FES has a positive influence on the outcome of surgical reconstruction of tendon and/or nerve transfers.

Conditions

  • Spinal Cord Injury Cervical

Interventions

DEVICE

Functional Electrical Stimulation

Functional electrical stimulation is applied with stimulators according to the lesion. In case of a upper motor neuron lesion the stimulation operates via nerve. For the stimulation surface electrodes are placed on the skin over the muscle belly. The stimulation of the innervated muscles will be conducted using the following conditions: 300-400 usec, 20-50 Hz, amplitude depends on the quality of muscle contraction (20-80 mA). the duty cycle of the stimulation is 3 sec. ramp up, 5 ec. plateau, 2 sec. ramp down, 10 sec. pause.

Sponsors & Collaborators

  • Swiss Paraplegic Research, Nottwil

    lead NETWORK

Principal Investigators

  • Jan Fridén, Prof. Dr. med. · Swiss Paraplegic Centre Nottwil, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2025-11-19
Completion
2025-11-19

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03048331 on ClinicalTrials.gov