NCT06736171 · Kessler Foundation
Post Stroke Ambulation Recovery Using Robotic Exoskeletons
(RERC)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Robotic Exoskeleton
EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA
OTHER
SOC
Standard of Care
Primary outcome measures
10MWT (Aim 1)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- West Orange, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 2, 2025 · Source of record for eligibility and locations