Recruiting

Robotic Exoskeletons

Sponsor:

Kessler Foundation

Code:

NCT06736171

Conditions

Hemiparesis After Stroke

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Robotic Exoskeleton

SOC

Study Details

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.

Conditions

Hemiparesis After Stroke

Study ID

NCT06736171

Start date

May 15, 2025

Status verified date

Aug, 2025

Completion date

Jun, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

Robotic Exoskeleton

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

SOC

Standard of Care

Primary outcome measure

  • 10MWT (Aim 1) [ Time Frame: Change from Baseline 10MWT at 4 weeks ]
  • 6MWT (Aim 1) [ Time Frame: Change from Baseline 6MWT at 4 weeks ]
  • TUG (Aim 1) [ Time Frame: Change from Baseline TUG at 4 weeks ]
  • DGI (Aim 1) [ Time Frame: Change from Baseline DGI at 4 weeks ]
  • Berg Balance Scale (Aim 1) [ Time Frame: Change from Baseline Berg at 4 weeks ]
  • Joint Range of Motion (kinematics) (Aim 2) [ Time Frame: Change from Baseline at 4 weeks ]
  • Temporospatial Loading (Aim 2) [ Time Frame: Change from Baseline at 4 weeks ]
  • Balance (Aim 2) [ Time Frame: Change from Baseline at 4 weeks ]
  • Survey for Community Participation (Aim 3) [ Time Frame: Change from Baseline at 4 weeks ]
  • Survey for Quality of Life (Aim 3) [ Time Frame: Change from Baseline at 4 weeks ]

Central Contacts and Locations

Central contacts

Sharon Franco

973-324-3521sfranco@kesslerfoundation.org

Kathleen Goworek

973-324-3560kgoworek@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Sharon Franco

973-324-3521sfranco@kesslerfoundation.org

Principal Investigator:

Karen J Nolan, PhD

More Information

Sponsor

Kessler Foundation

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2025-09-02.