Investigating FES Training for Spinal Cord Injury Recovery
Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury
This study is testing two types of exercise using electrical stimulation to see which one helps people with spinal cord injuries get stronger and improve their fitness better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Swiss Paraplegic Research, Nottwil Research network |
| Locations | 1 site (Nottwil, Canton of Lucerne) |
| Trial ID | NCT03621254 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two different functional electrical stimulation (FES) training modalities for patients with spinal cord injury (SCI). Participants will be randomized into two groups: one performing high-intensity interval training and the other engaging in continuous low-moderate intensity exercise. Both groups will use the Hasomed RehaStim™ exercise ergometer for 6-8 weeks, with sessions occurring three to four times per week. The primary outcomes assessed will include improvements in leg aerobic fitness and muscle strength.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-75 with motor complete spinal cord injuries between C7 and T10, who are at least six weeks post-trauma.
Not a fit: Patients with recent lower limb trauma, uncontrolled spasticity, or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies for improving fitness and strength in individuals with spinal cord injuries.
How similar studies have performed: Other studies have shown promise in using functional electrical stimulation for rehabilitation in spinal cord injury, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Greater than 6-weeks post-trauma after SCI. * Traumatic and atraumatic spinal cord injuries between C7 and T10 * Participants diagnosed with "motor complete' spinal cord injury American Spinal Injury Association Impairment Scale A and B. * Age between 18-75 years old. * Both male and female. * Have at least 90º bilateral knee flexion. * Able to perform FES muscle contractions (not FES intolerant). * Able to follow verbal instructions. Exclusion Criteria: * A recent history of trauma to the lower limb. * Severe or infected pressure sore on weight-bearing skin areas. * Illness caused by acute urinary tract infection. * Uncontrolled spasticity or pain. * History of cardiovascular / cardiorespiratory disease contraindicating exercise. * Uncontrolled orthostatic hypotension. * Unhealed decubiti at electrode placement area. * Recurrent and uncontrolled autonomic dysreflexia. * Active heterotopic ossification. * Other peripheral or central neurologic injury.
Where this trial is running
Nottwil, Canton of Lucerne
- Swiss Paraplegic Centre — Nottwil, Canton of Lucerne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Glen M Davis, Prof. Dr. — University of Sydney
- Study coordinator: Ines Bersch, PhD
- Email: ines.bersch@paraplegie.ch
- Phone: +41 41 939 42 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.