Hemiparesis After StrokeRERCNCT06736171
Post Stroke Ambulation Recovery Using Robotic Exoskeletons
A study testing Robotic Exoskeleton and SOC in people with Hemiparesis After Stroke, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hemiparesis After Stroke
- What is being tested?
- Robotic Exoskeleton and SOC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Sharon Franco, 973-324-3521, sfranco@kesslerfoundation.org
Karen J Nolan, PhD
About this study
Official title: 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.
Read the 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).
- Conditions
- Hemiparesis After Stroke
- Being tested
- Robotic Exoskeleton, SOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic ExoskeletonDevice
EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA
SOCOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
10MWT (Aim 1)
10 meter walk test to evaluate walking speed after stroke and in response to the intervention.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start15 May 2025
- Primary completion31 Dec 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis After StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen J. Nolan, PhD, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736171
- Sponsor's protocol ID
- R-1275-24
- Acronym
- RERC
- Status last verified
- Aug 2025
- First submitted
- 4 Dec 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription of Robotic Exoskeletons for Ambulation Recovery Post Stroke
- ClinicalTrials.gov ID
- NCT06736171
- Acronym / sponsor ID
- RERC / R-1275-24
- Conditions
- Hemiparesis After Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke RE | Experimental | Device: Robotic ExoskeletonParticipants 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. |
| Stroke SOC | Active comparator | Other: SOCParticipants 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic ExoskeletonEksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA | Device | Stroke RE |
| SOCStandard of Care | Other | Stroke SOC |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
Related trials for Hemiparesis After Stroke
Active, not recruiting
Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
Stroke, Hemiparesis
Recruiting
Telerehabilitation for Post-Stroke Hand Function
Stroke
RecruitingObservational study
Quadriceps Muscle Activity and Gait Kinematics in Patients With Post-Stroke Stiff-Knee Gait Compared With Healthy Controls
Stroke, Hemiparesis
Not yet recruiting
Deep Brain Stimulation + Therapy for Stroke
Stroke, Dysarthria
Active, not recruiting
Comparative Effects of CIMT and TOT on Hand Function Recovery in Post Stroke Patients
Poststroke/CVA Hemiparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Exoskeleton and SOC in people with Hemiparesis After Stroke, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Franco (973-324-3521, sfranco@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10MWT (Aim 1) (time frame: Change from Baseline 10MWT at 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.