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Pilot study: FES-assisted gait training intervention to improve gait in individuals with an incomplete spinal cord injury

Pilot study: FES-assisted gait training intervention to improve gait in individuals with an incomplete spinal cord injury - SCI: FES-WALK (pilot study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57740
Enrollment
5
Registered
2023-03-02
Start date
2023-05-10
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal cord injury/dwarslaesie broken neck disruption communication within the nervous system

Interventions

An FES-assisted gait intervention. Participants will walk on a treadmill for 10 weeks, twice a week for 30 minutes with FES (and BWS). Before and after the gait training sessions, the pre- and post

Sponsors

Revalidatiecentrum Reade
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime frame
Primairy outcome parameters are the feasibility and safety.

Secondary

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)