CVAPhase 1RE-AssistNCT04309305
Robotic Exoskeleton Assisted Gait Post Stroke
A Phase 1 study testing EksoGT™, Ekso Bionics, Berkley, CA, USA in people with CVA and Gait, Hemiplegic, run by Kessler Foundation at 1 site in United States.
Trial summary
The current investigation takes advantage of both a progressive and adaptive assist-as-needed massed practice and time-sensitive neuroplasticity through exoskeleton assisted walking in order to induce greater recovery-oriented CNS plasticity and consequent gains in more independent walking. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- CVA, Gait, Hemiplegic
- What is being tested?
- EksoGT™, Ekso Bionics, Berkley, CA, USA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 1 Sep 2026
- Phase
- Phase 1
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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke survivors < 4 weeks from most recent stroke.
- Age: 21- 80 years
- Unilateral hemiparesis
- Medical clearance by the Medical Director
- Be able to physically fit into the exoskeleton device.
- Have joint range of motion within normal functional limits for ambulation.
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- Have sufficient strength to use the hemiwalker, cane or walker (etc. assistive device) while wearing the RE.
- 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.
- No history of injury or pathology to the unaffected limb.
- physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.
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 study.
- Severe cognitive or psychiatric problems as well as incontinence might be contraindications to start training with a RE.
- History of severe cardiac disease such as myocardial infarction, congestive heart failure
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- Uncontrolled seizure disorder.
- Uncontrolled spasticity or joint contracture that would interfere with walking in the RE and limits normal ROM during ambulation with assistive devices.
- Neuromuscular or neurological pathologies (e.g., Parkinson's disease, spinal cord injury, or traumatic brain injury with evidence of motor weakness and multiple sclerosis) that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs
- Orthopedic pathologies or history that will interfere with ambulation or limit the ROM of the lower limbs (e.g., knee replacement, fixed contractures, inflammation)
- Any metal implants that are NOT MRI-compatible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Functional and Neurophysiological Effects of a Progressive Robot Assisted Gait Intervention Early Post Stroke
The current investigation takes advantage of both a progressive and adaptive assist-as-needed massed practice and time-sensitive neuroplasticity through exoskeleton assisted walking in order to induce greater recovery-oriented CNS plasticity and consequent gains in more independent walking.
Read the detailed description
The purpose of this research study is to assess whether using a wearable device, called the robotic exoskeleton (RE), can be helpful in improving recovery of walking in adults who have recently had a stroke. The study will compare the walking abilities of people who went through standard of care treatment after a stroke to those who used the robotic exoskeleton as part of their rehabilitation. This study will also look at the effects walking in the RE has on brain activity. The name of the robotic exoskeleton that is being used in this study is the EksoTM.
- Conditions
- CVA, Gait, Hemiplegic
- Being tested
- EksoGT™, Ekso Bionics, Berkley, CA, USA, Standard of Care, No Intervention
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EksoGT™, Ekso Bionics, Berkley, CA, USADevice
The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking.
Standard of CareOther
Standard gait therapy provided by licensed physical therapists post stroke.
No InterventionOther
Testing Only
| Study group | Role | What they receive |
|---|---|---|
| Stroke RE | Experimental | After discharge from the acute rehabilitation facility, participants in the stroke RE group will participate 3 days a week for 10 weeks in robotic exoskeleton gait training provided by a trained, licensed physical therapist. Participants will be permitted to participate in additional prescribed standard physical therapy on their own. Receives: Device: EksoGT™, Ekso Bionics, Berkley, CA, USA |
| Stroke SOC | Active comparator | After discharge from the acute rehabilitation facility, participants in the stroke SOC group will participate 3 days a week for 10 weeks in standard of care gait training provided by a licensed physical therapist. Participants will be permitted to participate in additional prescribed standard physical therapy on their own. Receives: Other: Standard of Care |
| Healthy Control | Other | Participants in the healthy control group will not participate in any gait training. Healthy control participants will only be asked to complete 3 testing sessions. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM) (aim 1)
a conventional assessment measure of motor function
Measured: Change from Baseline FIM at 10 weeks
Within-brain functional connectivity (aim 2)
fMRI connectivity between selected regions of interest within the sensorimotor and attention networks.
Measured: Change from Baseline Within-brain functional connectivity at 10 weeks
TMS recruitment curve slope (aim 3)
A recruitment curve created using measure of primary motor cortex Motor Evoked Potential (MEP) at several stimulation thresholds.
Measured: Change from Baseline TMS recruitment curve slope at 10 weeks
electroencephalogram (EEG) (aim 3)
a measure of brain activation at different phases of gait cycle (swing versus double support).
Measured: Change from Baseline EEG at 10 weeks
electromyography (EMG) (aim 3)
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
Measured: Change from Baseline EMG at 10 weeks
10MWT (aims 1-3)
10 meters walking test to evaluate walking speedafter stroke and in response to the intervention.
Measured: Change from Baseline 10MWT at 10 weeks
6MWT (aims 1-3)
6 minutes walking test to evaluate endurancein connectivity after stroke and in response to the intervention.
Measured: Change from Baseline 6MWT at 10 weeks
TUG (aims 1-3)
time up and go (TUG) test
Measured: Change from Baseline TUG at 10 weeks
structural connectivity (aim 2)
Diffusion Tensor Imaging (DTI) and fractal dimensions (FD) measures of structural connectivity
Measured: Change from Baseline structural connectivity at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start30 Jan 2020
- Primary completion1 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVAStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 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
- Investigators
- Karen J. Nolan, PhD, Principal investigator, Kessler FoundationSoha Saleh, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309305
- Sponsor's protocol ID
- R-1073-19
- Acronym
- RE-Assist
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2020
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No