Using electrical stimulation cycling with robotic rehab for spinal cord injury recovery
The Effect of Adding Functional Electrical Stimulation Bicycle Ergometry to Robotic Rehabilitation on Walking Function and Lower Extremity Functional Recovery in Patients With Chronic Incomplete Spinal Cord Injury
This study is testing if adding electrical stimulation while using a robotic bike can help people with spinal cord injuries recover better than just using the robot alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT06541197 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of adding functional electrical stimulation (FES) bicycle ergometry to robotic rehabilitation for patients with chronic incomplete spinal cord injuries (SCI). The authors hypothesize that this combined approach will lead to improved lower extremity functional recovery and ambulation compared to robotic rehabilitation alone. Participants will include individuals aged 18 to 65 who have been diagnosed with motor incomplete SCI and can walk at least 10 meters independently or with assistance. The study aims to provide insights into enhancing rehabilitation outcomes for this patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 65 with motor incomplete spinal cord injuries who can walk at least 10 meters.
Not a fit: Patients with severe spasticity, joint contractures, or other contraindications for walking exercises may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and functional recovery for patients with spinal cord injuries.
How similar studies have performed: While this specific combination of therapies has not been extensively studied, previous research has shown promise in using robotic rehabilitation for spinal cord injury recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Motor Incomplete spinal cord injury (ASIA C and D). 2. At least 6 months post spinal cord injury. 3. Age between 18 and 65 years. 4. Ability to walk at least 10 meters independently or with assistive devices such as a cane or crutches. 5. Signed informed consent form indicating willingness to participate in the study. Exclusion Criteria: 1. Severe spasticity or joint contracture in the lower extremities that impedes movement. 2. Presence of metallic implants in the lower extremities. 3. Stage 2 or higher pressure ulcers on the sacral or coccygeal regions. 4. Co-existing peripheral neuropathy. 5. Permanent urinary catheter use. 6. Contraindications for walking exercises (e.g., cognitive impairment preventing exercise compliance, unstable epilepsy or unexplained convulsions, unstable acute cardiac arrhythmia or heart failure, presence of a cardiac pacemaker). 7. Psychiatric disorders or cognitive problems that prevent completing questionnaires and assessment scales. 8. Presence of other neurological or muscular diseases.
Where this trial is running
Ankara
- Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital — Ankara, Turkey (Recruiting)
Study contacts
- Principal investigator: Merve Örücü Atar, MD — Associate professor
- Study coordinator: Merve Örücü Atar, MD
- Email: drmerveorucu@hotmail.com
- Phone: +903122912443
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.