Post Stroke Ambulation Recovery Using Robotic Exoskeletons

NCT ID: NCT06736171

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2030-06-30

Brief 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.

Detailed 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).

Conditions

Hemiparesis After Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stroke RE

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.

Group Type: EXPERIMENTAL

Robotic Exoskeleton

Intervention Type: DEVICE

EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA

Stroke SOC

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.

Group Type: ACTIVE_COMPARATOR

SOC

Intervention Type: OTHER

Standard of Care

Interventions

Robotic Exoskeleton

EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA

Intervention Type: DEVICE

SOC

Standard of Care

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Karen J. Nolan, PhD

Associate Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kessler Foundation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sharon Franco

Role: CONTACT

sfranco@kesslerfoundation.org

973-324-3521

Kathleen Goworek

Role: CONTACT

kgoworek@kesslerfoundation.org

973-324-3560

Facility Contacts

Sharon Franco

Role: primary

sfranco@kesslerfoundation.org

973-324-3521

Other Identifiers

R-1275-24

Identifier Type: -

Identifier Source: org_study_id