FESFunctional Electrical Stimulation in Tetraplegic Reconstructive Hand Surgery
This study aims to assess how functional electrical stimulation during hand surgery can change muscle strength and power in individuals with tetraplegia.
Functional Electrical Stimulation
Nervous System Diseases+3
+ Neurologic Manifestations
+ Paralysis
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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