Combining exoskeleton-assisted walking with spinal stimulation for spinal cord injury recovery
Exoskeleton and Spinal Cord Stimulation for SCI
NA · Kessler Foundation · NCT03096197
This study is testing if using a special walking robot along with nerve stimulation can help people with partial spinal cord injuries walk better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kessler Foundation (other) |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT03096197 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of combining transcutaneous lumbosacral stimulation (TLS) with exoskeleton-assisted walking (EAW) in improving walking recovery for individuals with incomplete spinal cord injuries. A total of 24 participants will be randomly assigned to either an EAW+TLS group or an EAW alone group, with each group undergoing 80 sessions of robotic training over 28 weeks. The EAW+TLS group will receive stimulation during their walking sessions, while the control group will not. The study will assess the impact of this combined approach on ambulation difficulties and muscle spasticity.
Who should consider this trial
Good fit: Ideal candidates are non-walking individuals aged 21-58 with incomplete spinal cord injuries who are wheelchair reliant.
Not a fit: Patients with a history of broken bones or bone diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance walking recovery and mobility for individuals with spinal cord injuries.
How similar studies have performed: Other studies have shown promise in using exoskeletons for rehabilitation, but the combination with TLS is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study a participant must: * be a non-walker with an SCI greater than 6 years post injury; * have a lower extremity motor score greater or equal to 16 as measured by the International Standards for Neurological Classification of SCI exam; * be between the ages of 18-65 years old; * have a spinal cord injury at a neurological level of injury as determined by study staff between C5-T-10; * be wheelchair reliant 100% of the time; * have knee bone mineral density great than .5755gm/cm2 as determined by study staff; Exclusion Criteria: * have a history of broken or fractured bones. * have a history of bone trauma or bone disease.
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Gail F. Forrest, PhD — Kessler Foundation
- Study coordinator: Gail F Forrest, PhD
- Email: gforrest@kesslerfoundation.org
- Phone: 973-324-3518
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.
Conditions: Spinal Cord Injury, Ambulation Difficulty, Muscle Spasticity, Spinal Cord injury, Transcutaneous lumbosacral stimulation, Exoskeleton-Assisted Walking