Robotic exoskeletons to help walking recovery after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kessler Foundation
  West Orange, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Sharon Franco
• Email: sfranco@kesslerfoundation.org
• Phone: 973-324-3521

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.