Suspended

FESFunctional Electrical Stimulation in Tetraplegic Reconstructive Hand Surgery

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Study Aim

This study aims to assess how functional electrical stimulation during hand surgery can change muscle strength and power in individuals with tetraplegia.

What is being tested

Functional Electrical Stimulation

Device
Who is being recruted

Nervous System Diseases+3

+ Neurologic Manifestations

+ Paralysis

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2017
See protocol details

Summary

Principal SponsorSwiss Paraplegic Research, Nottwil
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2017

Actual date on which the first participant was enrolled.

This study focuses on the use of Functional Electrical Stimulation (FES) in patients with tetraplegia who are undergoing reconstructive surgery for their arms or hands. Tetraplegia often results in limited arm and hand function, and FES is a method used to enhance muscle activity. The research aims to determine if using FES before and after surgery can improve muscle strength and function compared to the standard therapy alone. This could potentially lead to better outcomes for individuals with tetraplegia, providing them with improved ability to use their arms and hands, which is crucial for daily activities and independence. Participants in the study include 30 tetraplegic patients scheduled for reconstructive surgery at the Swiss Paraplegic Centre. They are divided into two groups: one receiving standard physical and occupational therapy, and the other receiving the same therapy with additional FES. The FES treatment involves sessions three times a week, each lasting 30 minutes, for three months both before and after surgery. Researchers will measure changes in muscle strength and function at four different points in time, using tests like muscle strength measurements and ultrasound to assess muscle volume. This will help determine the effectiveness of FES in enhancing surgical outcomes for these patients.

Official TitleThe Effect of Functional Electrical Stimulation (FES) in Tetraplegia Reconstructive Surgery of the Upper Limbs - A Pilot Study
Principal SponsorSwiss Paraplegic Research, Nottwil
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesNeurologic ManifestationsParalysisQuadriplegiaSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

Inclusion Criteria: * traumatic or non-traumatic (\> 6 month) spinal cord injury * Age ≥ 18 years * Level of lesion C4 - Th1 * American Spinal Cord Injury Association Impairment Scale (AIS) A/B/C/D * Planned reconstructive hand or arm surgery at the Swiss Paraplegic Centre Nottwil * Signed informed consent Exclusion Criteria: * Patients during primary rehabilitation * Patients' inability to follow the study, e.g. mental-health problems, language problems, dementia etc. * Pregnancy (anamnestic)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Before surgery, the donor muscle is stimulated via surface electrodes in a loaded position or against resistance 3 times a week for 30 minutes. After surgery, the patients receive the same standard therapy as the control group. The electrical stimulation is performed once a day in combination with standard therapy for 30 minutes against gravity or resistance or in a loaded position.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Swiss Paraplegic Centre

Nottwil, SwitzerlandOpen Swiss Paraplegic Centre in Google Maps
SuspendedOne Study Center