Robotic exoskeletons to help walking recovery after stroke
Prescription of Robotic Exoskeletons for Ambulation Recovery Post Stroke
This study tries different robotic exoskeletons to see which helps people 3 to 8 months after a stroke with hemiparesis walk better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT06736171 on ClinicalTrials.gov |
What this trial studies
This interventional study will assign people with unilateral hemiparesis 3–8 months after stroke to gait training with one of three commercially available robotic exoskeletons (AtalanteX, Ekso NR, Restore) or to standard of care. Participants must meet device-fit and medical clearance criteria and be cognitively able to follow instructions. The trial will collect biomechanical, functional, community participation, and quality-of-life measures before and after the intervention to compare outcomes across groups. Findings are intended to help clinicians prescribe the most appropriate exoskeleton based on individual deficits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 to 80 who are 3 to 8 months post-stroke with unilateral hemiparesis, can physically fit the device (about 60–76 inches tall and under 220 pounds), are medically cleared, and can follow study instructions and consent.
Not a fit: Patients outside the age or post-stroke window, those with bilateral limb pathology, significant cognitive impairment, inability to fit the device, or medical contraindications are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians match patients to the exoskeleton most likely to improve walking, mobility, and quality of life.
How similar studies have performed: Previous studies of robotic exoskeletons have shown improvements in gait and mobility after stroke, but direct head-to-head comparisons between specific devices are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stroke survivors 3 - 8 months from a recent stroke. * Age: 50 - 80 years * Unilateral hemiparesis * Medical clearance by the Medical Director * Be able to physically fit into the exoskeleton device: Height between 60\" and 76\" and weight below 220 lbs * Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation (e.g. can follow directions). * Adequate cognitive function to give informed consent, understand the training, instructions, use investigational devices and give adequate feedback. * Have a joint range of motion within normal functional limits for ambulation. * Have sufficient strength to use the hemiwalker, cane or walker (etc. assistive device) while wearing the RE. * No history of injury or pathology to the unaffected limb. * Have an appropriate walking speed as determined by the study staff. Exclusion Criteria: * Any medical issue that precludes full weight-bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity). * Skin issues that would prevent wearing the device. * Pre-existing condition that caused exercise intolerance (documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure). * Hospitalization for heart attack, heart surgery, or acute heart failure within 3 months of enrollment in the study. * Uncontrolled seizure disorder, spasticity, or joint contracture that would interfere with walking. * Neuromuscular, neurological, or orthopedic pathologies that interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs.
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Sharon Franco
- Email: sfranco@kesslerfoundation.org
- Phone: 973-324-3521
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.