spinal cord injury/dwarslaesie broken neck disruption communication within the nervous system
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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 BWS. Be able to do the 10MWT with assistive devices and/or support from 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
Exclusion criteria: Cardiopulmonary disease. Flaccid paralysis.** Musculoskeletal dysfunction, uncured fractures, contractures, pressure injuries, or infections that could impede the intended training.*** Clinically significant depression.*** Drug abuse.** Usage of anti-spasticity medication.*** Botox injections in the lower extremities during the last six months.*** Women who are or who are planning to get pregnant during the study period.*** Neurostimulator, pacemaker, or other device that prevents the safe use of electrical stimulation present in the body.*** Coagulopathy, heart risk factors, or other important medical risk factors that will require surgery.** Inability to communicate well or have cognitive disorders.** Very high sensitivity to electrical stimulation,*i.e.,*sensitivity threshold is reached before motor responses are observed in all target muscles.** Currently being enrolled in another training study.** 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 |
|---|---|
| Primairy outcome parameters are the feasibility and safety. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are possible improvements in the spatiotemporal parameters and the muscle activity pattern (pre- and post-intervention) and the improvements during the training sessions. We will also investigate if the possible positive effects of the FES-assisted gait intervention persist 10 weeks after the post-intervention measurements (follow-up). | — |
Countries
Netherlands