Robotic gait training for spinal cord injury recovery
Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury
This study is testing how different schedules of robotic walking training, along with brain stimulation, can help people with spinal cord injuries recover better during and after rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 16 Years to 85 Years |
| Sex | All |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05218447 on ClinicalTrials.gov |
What this trial studies
The DOOR SCI project investigates the effects of different dosing frequencies of robotic gait training (RGT) combined with transcranial magnetic stimulation (TMS) on recovery outcomes for patients with spinal cord injuries (SCI). This interventional study will assess the impact of RGT initiated during inpatient rehabilitation and continued into outpatient care, focusing on neuroplasticity and functional improvements. Participants will undergo RGT at varying frequencies over a nine-month period, with outcomes measured at multiple time points to determine the optimal approach for enhancing recovery. The study aims to fill the gap in clinical guidelines regarding gait retraining for individuals with motor incomplete SCI.
Who should consider this trial
Good fit: Ideal candidates include individuals with all types of motor incomplete spinal cord injuries who are in the acute or subacute phase of recovery and are medically stable.
Not a fit: Patients with concurrent moderate to severe traumatic brain injury, degenerative diagnoses, or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation protocols that enhance recovery and functional outcomes for patients with spinal cord injuries.
How similar studies have performed: While robotic gait training has shown promise in chronic SCI cases, this approach in the acute setting is relatively novel and has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All types of motor incomplete SCI (traumatic and non-traumatic) * Acute/Subacute phase of recovery * Medically stable as deemed by physician * Undergoing medical care and rehabilitation at Baylor Scott \& White Institute for Rehabilitation * Both genders and all races and ethnicities * Meet the Ekso robotic exoskeleton frame limitations * Continence of or a program for bladder and bowel management Exclusion Criteria: * Concurrent moderate to severe traumatic brain injury (TBI) * Degenerative diagnoses * Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment * Pregnancy
Where this trial is running
Dallas, Texas
- Baylor Scott & White Institute for Rehabilitation — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Chad Swank, PhD, PT, NCS — Baylor Research Institute
- Study coordinator: Faith Meza, MPH
- Email: Faith.Meza@BSWHealth.org
- Phone: 469-531-1577
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.