Post Stroke Ambulation Recovery Using Robotic Exoskeletons
Prescription of Robotic Exoskeletons for Ambulation Recovery Post Stroke
Kessler Foundation
96 participants
May 15, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this research study is to evaluate and compare different robotic exoskeletons (RE) and identify which is most appropriate for gait training for each patient based off their specific needs. This will help guide clinicians in prescribing the appropriate RE for rehabilitation.
Eligibility
Inclusion Criteria11
- 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 Criteria6
- 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.
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Interventions
EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA
Standard of Care
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06736171