High intensity training using exoskeletons for spinal cord injury rehabilitation
High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
This study is testing if using robotic exoskeletons for high-intensity walking training can help people with spinal cord injuries improve their walking ability and overall function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04973852 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and potential effectiveness of high cardiovascular intensity training using overground robotic exoskeletons for patients with spinal cord injuries. Participants will engage in five walking training sessions with the Ekso exoskeleton, alongside pre- and post-training assessments of balance, walking speed, endurance, and breathing. The goal is to determine if high-intensity training can improve walking ability and functional outcomes in an inpatient rehabilitation setting.
Who should consider this trial
Good fit: Ideal candidates include individuals with motor incomplete spinal cord injuries or cerebrovascular accidents who can fit into the exoskeleton and meet specific mobility criteria.
Not a fit: Patients with severe comorbidities, uncontrolled spasticity, or other neurological injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes and walking ability for patients with spinal cord injuries.
How similar studies have performed: Other studies have shown promising results with high-intensity training and exoskeletons, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to achieve adequate fit within the exoskeleton * Diagnosis of CVA or motor incomplete SCI (AIS C or D) * Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit * Intact skin on all surfaces in contact with device and load-bearing surfaces * Weight \<220 pounds Exclusion Criteria: * Pregnancy * Spinal instability * Unhealed limb or pelvic fractures or any condition restricting weight-bearing in limbs * Diagnosis of other neurological injuries other than CVA or SCI * Uncontrolled spasticity (≥3 on Modified Ashworth Scale) * Colostomy * Decreased range of motion or contractures in legs (\>10° at hips, knees, or ankles) * Uncontrolled autonomic dysreflexia * Unresolved deep vein thrombosis * Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension * Inability to follow 3 step commands * Severe comorbidities: active infections, heart, lung, or circulatory conditions * Pressure sores, impaired skin integrity * Use of mechanical ventilation for respiratory support
Where this trial is running
Houston, Texas
- NeuroRecovery Research Center at TIRR Memorial Hermann — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Shuo-Hsiu (James) Chang — The University of Texas Health Sciences Center at Houston
- Study coordinator: Shuo-Hsiu (James) Chang
- Email: shuo-hsiu.chang@uth.tmc.edu
- Phone: 713-799-7016
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.