Post Stroke Ambulation Recovery Using Robotic Exoskeletons (RERC)

Prescription of Robotic Exoskeletons for Ambulation Recovery Post Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Hemiparesis After Stroke
• Intervention / Treatment: Device: Robotic Exoskeleton; Other: SOC

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).

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharon Franco; Phone Number: 973-324-3521; Email: sfranco@kesslerfoundation.org
• Study Contact Backup: Name: Kathleen Goworek; Phone Number: 973-324-3560; Email: kgoworek@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Contact: Sharon Franco; Phone Number: 973-324-3521; Email: sfranco@kesslerfoundation.org
      • Principal Investigator: Karen J Nolan, PhD
      • Principal Investigator: Kiran K Karunakaran, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Robotic Exoskeleton; EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA
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.	Other: SOC; Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Paresis; Equipment and Supplies; Exoskeleton Device
• Other Study ID Numbers: R-1275-24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes