MedDataX Logo

FES-assisted Gait Intervention in People with Spinal Cord Injury - Pilot Study

NCT ID: NCT05908175

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-06-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A spinal cord injury (SCI) disrupts the communication within the nervous system, leading to limitations in sensorimotor activities such as walking. Regular use of functional electrical stimulation (FES) can result in recovery of voluntary muscle control and muscle strength. Locomotor training with FES may be a promising method to improve gait function. The primary objective of this pilot study is to assess the feasibility and safety of an FES-assisted gait training intervention. Secondary objectives are to assess the effects of an FES-assisted gait training intervention on gait function.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A spinal cord injury (SCI) disrupts the communication within the nervous system, leading to limitations in sensorimotor activities, such as walking. These limitations are associated with muscle weakness, a disturbance of the reflex activity, and the inability or difficulty to recruit muscles below the lesion. Regular use of functional electrical stimulation (FES) can result in recovery of voluntary muscle control and muscle strength. Studies that investigated the effect of locomotor training on a treadmill with functional electrical stimulation and/or body weight support (BWS) show improved function of the lower limbs. FES-assisted gait therapy may be a promising method for improving gait function in individuals with an incomplete SCI. Therefore, this study will investigate if an FES-assisted gait (with BWS) is feasible and safe. This study will also investigfate if an FES-assisted gait can improve gait function in people with an incomplete SCI.

Primary objective of this pilot study is to assess the feasibility and safety of an FES-assisted gait training intervention. The secondary objectives are to assess the effects of an FES-assisted gait training intervention on gait function.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

FES-assisted gait training intervention group

Group Type OTHER

FES-assisted gait training

Intervention Type OTHER

The participants will walk with functional electrical stimulation (and possible body weight support) on a treadmill for 10 weeks, twice a week for 30 minutes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FES-assisted gait training

The participants will walk with functional electrical stimulation (and possible body weight support) on a treadmill for 10 weeks, twice a week for 30 minutes.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Have a non-progressive incomplete SCI.
* Have limited motor abilities in the lower extremities.
* Be able to walk on a treadmill for 30 minutes (with body weight support).
* Be able to perform the 10 meter walk test overground with assistive devices and/or support form the researcher/physician.
* Have a stable medical condition.
* Have had the SCI for at least a year.
* Be at least 18 years of age.

Exclusion Criteria

* Cardiac arrhythmias or cardiac disease;
* Flaccid paralysis.
* Musculoskeletal dysfunction, uncured fractures, contractures, pressure injuries, or infections that could impede the intended training;
* A history of severe autonomic dysreflexia assessed with the 'Autonomic standards assessment';
* Neurostimulator, pacemaker, or other device that prevents the safe use of electrical stimulation present in the body;
* Very high sensitivity to electrical stimulation, i.e., sensitivity threshold is reached before motor responses are observed in all target muscles;
* Insufficient mastery of the Dutch language (speaking and reading);
* Severe cognitive or communicative disorders;
* Being or becoming pregnant during the study period;
* Severe psychiatric illness or disorders (at the discretion of the treating rehabilitation physician);
* Involved in another intervention study which may have an effect on the outcome measures of the present study;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stichting Reade

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Janssen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Stichting Reade

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stichting Reade

Amsterdam, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL82880.015.22

Identifier Type: OTHER

Identifier Source: secondary_id

W23.009

Identifier Type: -

Identifier Source: org_study_id