Post Stroke Ambulation Recovery Using Robotic Exoskeletons

NCT06736171 | Recruiting DMC FDA Device

• 1 other identifier: R-1275-24
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• 10MWT (Aim 1)

  10 meter walk test to evaluate walking speed after stroke and in response to the intervention.

  Change from Baseline 10MWT at 4 weeks

• 6MWT (Aim 1)

  6 minute walking test to evaluate endurance after stroke and in response to the intervention

  Change from Baseline 6MWT at 4 weeks

• TUG (Aim 1)

  Timed up and go (TUG) test to measure functional balance and walking ability after stroke and in response to the intervention.

  Change from Baseline TUG at 4 weeks

• DGI (Aim 1)

  Dynamic Gait Index (DGI) evaluates the ability to modify balance while walking in the presence of external demands after stroke and in response to the intervention.

  Change from Baseline DGI at 4 weeks

• Berg Balance Scale (Aim 1)

  Measure to assess static and dynamic balance and fall risk after stroke and in response to the intervention.

  Change from Baseline Berg at 4 weeks

• Joint Range of Motion (kinematics) (Aim 2)

  Kinematics gait data will be collected using a motion capture camera system to provide biomechanical outcomes.

  Change from Baseline at 4 weeks

• Temporospatial Loading (Aim 2)

  Step length, timing during gait cycle, limb symmetry will be collected using instrumented gait walkway and insoles.

  Change from Baseline at 4 weeks

• Balance (Aim 2)

  Static and dynamic balance in standing and seated positions after stroke and in response to the intervention (using Hunova (Movendo Inc, Genova, Italy) plaform).

  Change from Baseline at 4 weeks

• Survey for Community Participation (Aim 3)

  The Community Participation Indicators (CPI) is a self-reported 48 item objective measure survey.

  Change from Baseline at 4 weeks

• Survey for Quality of Life (Aim 3)

  The SS-QOL survey assesses health-related quality of life (QOL) specific to stroke survivors with 49 items across 12 domains.

  Change from Baseline at 4 weeks

Study Arms (2)

Stroke RE

EXPERIMENTAL

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.

Device: Robotic Exoskeleton

Stroke SOC

ACTIVE COMPARATOR

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.

Other: SOC

Interventions

Robotic Exoskeleton DEVICE

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

Stroke RE

SOC OTHER

Standard of Care

Stroke SOC

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Interventions

Exoskeleton Device

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Sharon Franco

CONTACT

973-324-3521; sfranco@kesslerfoundation.org

Kathleen Goworek

CONTACT

973-324-3560; kgoworek@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 16, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)