Spinal Cord Injury, Broken neck, Disruption communication within the nervoussystem A spinal cord injury is damage to the spinal cord, which causes signals between the brain and the rest of the body (such as the legs) to no longer be transmitted properly. This can lead to paralysis or problems with movement and sensation
Conditions
Interventions
During the intervention — (1) conventional gait training without stimulation, (2) gait training assisted by FES — participants will walk for 30 minutes twice a week on an instrumented treadmill (walki
Training 
In total, there will be 20 conventional gait training sessions without stimulation and 20 gait training sessions with FES. Participants will walk for 30 minutes (excluding breaks and preparation time)
Participan
Sponsors
Reade
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Have a non-progressive chronic (>1 yrs) incomplete SCI between C4 and T12 with an ASIA score of C or D. Be at least 18 years of age. Be able to take some steps (with assistive devices or in the bridge). As part of the inclusion process, responsiveness to electrical stimulation will be assessed using a Compex electrical stimulator (Compex SP 4.0; Compex Medical SA, Switzerland) to ensure potential participant's respond well to ES, and to ensure that the sensitivity threshold is not reached before motor response in all target muscles.
Exclusion criteria
Exclusion criteria: Flaccid paralysis. Musculoskeletal dysfunction, uncured fractures, contractures, pressure injuries, or infections that could impede the intended training. Botox injections in the lower extremities during the last six months. Women who are (planning to get) pregnant during the study period. Implanted neurostimulator or stimulator of any kind that can have an influence on the safe use of ES. Pacemaker, or other device, present in the body that prevents the safe use of ES. Inability to communicate well or have cognitive disorders. Currently being enrolled in another training study or participated in a training study in the previous six months. Having an illness that has a high chance of preventing them to be able to perform the training at a sufficient frequency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters is the change in overground walking speed, assessed using the 10-meter walk test (10MWT) at T0, T1, T2, and T3. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are:Overground walking (recorded during the 10MWT* (at T0, T1, T2 and T3)):Changes in spatiotemporal parameters (distance, time, step length, step width, cadence).Changes in Walking Index Spinal Cord Injury (WISCI) II score.Changes in Hoffer classification score.Treadmill walking:Changes in spatiotemporal parameters (distance, time, duration) during each training session (conventional gait training and FES-assisted gait training).Muscle control will be evaluated based on the following parameters:Muscle activity of the same muscles evaluated in Berkelmans et al. (2025) during overground gait/10MWT (at T0, T1, and T2).Gait kinematics measured during overground gait/10MWT (at T0, T1 and T2). Muscle strength will be evaluated based on the following parameter: Change in muscle strength (at T0, T1 and T2). | — |
Countries
Netherlands
Contacts
Public ContactS. Berkelmans
Reade
Outcome results
None listed