Post Stroke Ambulation Recovery Using Robotic Exoskeletons

Not Applicable

Not yet recruiting

• Conditions: Hemiparesis After Stroke

• Registration Number: NCT06736171
• Lead Sponsor: Kessler Foundation

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).

Study Timeline

• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Study Start: 2025-04-15
• Primary Completion: 2029-12-31
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
10MWT (Aim 1)	Change from Baseline 10MWT at 4 weeks	10 meter walk test to evaluate walking speed after stroke and in response to the intervention.
6MWT (Aim 1)	Change from Baseline 6MWT at 4 weeks	6 minute walking test to evaluate endurance after stroke and in response to the intervention
TUG (Aim 1)	Change from Baseline TUG at 4 weeks	Timed up and go (TUG) test to measure functional balance and walking ability after stroke and in response to the intervention.
DGI (Aim 1)	Change from Baseline DGI at 4 weeks	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.
Berg Balance Scale (Aim 1)	Change from Baseline Berg at 4 weeks	Measure to assess static and dynamic balance and fall risk after stroke and in response to the intervention.
Joint Range of Motion (kinematics) (Aim 2)	Change from Baseline at 4 weeks	Kinematics gait data will be collected using a motion capture camera system to provide biomechanical outcomes.
Temporospatial Loading (Aim 2)	Change from Baseline at 4 weeks	Step length, timing during gait cycle, limb symmetry will be collected using instrumented gait walkway and insoles.
Balance (Aim 2)	Change from Baseline at 4 weeks	Static and dynamic balance in standing and seated positions after stroke and in response to the intervention (using Hunova (Movendo Inc, Genova, Italy) plaform).
Survey for Community Participation (Aim 3)	Change from Baseline at 4 weeks	The Community Participation Indicators (CPI) is a self-reported 48 item objective measure survey.
Survey for Quality of Life (Aim 3)	Change from Baseline at 4 weeks	The SS-QOL survey assesses health-related quality of life (QOL) specific to stroke survivors with 49 items across 12 domains.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States