Back to resultsRobotic Exoskeleton Assisted Gait Post Stroke (RE-Assist)
Primary Purpose
CVA, Gait, Hemiplegic
Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EksoGT™, Ekso Bionics, Berkley, CA, USA
Standard of Care
No Intervention
Sponsored by
About this trial
This is an interventional treatment trial for CVA
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
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 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
- 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
Sites / Locations
- Kessler Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Stroke RE
Stroke SOC
Healthy Control
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Functional Independence Measure (FIM) (aim 1)
a conventional assessment measure of motor function
Within-brain functional connectivity (aim 2)
fMRI connectivity between selected regions of interest within the sensorimotor and attention networks.
TMS recruitment curve slope (aim 3)
A recruitment curve created using measure of primary motor cortex Motor Evoked Potential (MEP) at several stimulation thresholds.
electroencephalogram (EEG) (aim 3)
a measure of brain activation at different phases of gait cycle (swing versus double support).
electromyography (EMG) (aim 3)
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
10MWT (aims 1-3)
10 meters walking test to evaluate walking speedafter stroke and in response to the intervention.
6MWT (aims 1-3)
6 minutes walking test to evaluate endurancein connectivity after stroke and in response to the intervention.
TUG (aims 1-3)
time up and go (TUG) test
structural connectivity (aim 2)
Diffusion Tensor Imaging (DTI) and fractal dimensions (FD) measures of structural connectivity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04309305
Brief Title
Robotic Exoskeleton Assisted Gait Post Stroke
Acronym
RE-Assist
Official Title
Functional and Neurophysiological Effects of a Progressive Robot Assisted Gait Intervention Early Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CVA, Gait, Hemiplegic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stroke RE
Arm Type
Experimental
Arm Description
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.
Arm Title
Stroke SOC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy Control
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EksoGT™, Ekso Bionics, Berkley, CA, USA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard gait therapy provided by licensed physical therapists post stroke.
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
Testing Only
Primary Outcome Measure Information:
Title
Functional Independence Measure (FIM) (aim 1)
Description
a conventional assessment measure of motor function
Time Frame
Change from Baseline FIM at 10 weeks
Title
Within-brain functional connectivity (aim 2)
Description
fMRI connectivity between selected regions of interest within the sensorimotor and attention networks.
Time Frame
Change from Baseline Within-brain functional connectivity at 10 weeks
Title
TMS recruitment curve slope (aim 3)
Description
A recruitment curve created using measure of primary motor cortex Motor Evoked Potential (MEP) at several stimulation thresholds.
Time Frame
Change from Baseline TMS recruitment curve slope at 10 weeks
Title
electroencephalogram (EEG) (aim 3)
Description
a measure of brain activation at different phases of gait cycle (swing versus double support).
Time Frame
Change from Baseline EEG at 10 weeks
Title
electromyography (EMG) (aim 3)
Description
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
Time Frame
Change from Baseline EMG at 10 weeks
Title
10MWT (aims 1-3)
Description
10 meters walking test to evaluate walking speedafter stroke and in response to the intervention.
Time Frame
Change from Baseline 10MWT at 10 weeks
Title
6MWT (aims 1-3)
Description
6 minutes walking test to evaluate endurancein connectivity after stroke and in response to the intervention.
Time Frame
Change from Baseline 6MWT at 10 weeks
Title
TUG (aims 1-3)
Description
time up and go (TUG) test
Time Frame
Change from Baseline TUG at 10 weeks
Title
structural connectivity (aim 2)
Description
Diffusion Tensor Imaging (DTI) and fractal dimensions (FD) measures of structural connectivity
Time Frame
Change from Baseline structural connectivity at 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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.
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 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J. Nolan, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soha Saleh, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Robotic Exoskeleton Assisted Gait Post Stroke
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