Post Stroke Ambulation Recovery Using Robotic Exoskeletons (RERC)

Kessler Foundation

Status: Enrolling

Conditions: Hemiparesis After Stroke

Treatments: Other: SOC; Device: Robotic Exoskeleton

Study type: Interventional

Funder types: Other

Identifiers

NCT06736171

R-1275-24

Details and patient eligibility

About

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.

Full description

This study will systematically compare various commercially available REs and aid in identifying the appropriate devices for gait training prescription in individuals post-stroke based on their deficits. The objective of this study is to evaluate and compare the four groups (3 REs and standard of care treatment) using biomechanical, functional and community participation & quality of life metrics. The robotic exoskeletons being used in this study are the AtalanteX (Wandercraft), Ekso NR (Ekso Bionics), and Restore (Lifeward).

Enrollment: 96 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Stroke RE

Experimental group

Description:

Participants in the stroke RE group will participate 3-4 weeks, 2-3 times a week for a total of 9 robotic exoskeleton gait training sessions provided by a trained, licensed physical therapist.

Treatment:

Device: Robotic Exoskeleton

Stroke SOC

Active Comparator group

Description:

Participants in the stroke SOC group will participate 3-4 weeks, 2-3 times a week for a total of 9 standard of care gait training sessions provided by a trained, licensed physical therapist.

Treatment:

Other: SOC