Robotic Exoskeleton Assisted Gait Post Stroke (RE-Assist)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gait, Hemiplegic; CVA
• Intervention / Treatment: Device: EksoGT™, Ekso Bionics, Berkley, CA, USA; Other: Standard of Care; Other: No Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke RE; 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.	Device: EksoGT™, Ekso Bionics, Berkley, CA, USA; 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.
Active Comparator: Stroke SOC; 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.	Other: Standard of Care; Standard gait therapy provided by licensed physical therapists post stroke.
Other: Healthy Control; 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.	Other: No Intervention; Testing Only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Independence Measure (FIM) (aim 1)	a conventional assessment measure of motor function	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.	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.	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).	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).	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.	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.	Change from Baseline 6MWT at 10 weeks
TUG (aims 1-3)	time up and go (TUG) test	Change from Baseline TUG at 10 weeks
structural connectivity (aim 2)	Diffusion Tensor Imaging (DTI) and fractal dimensions (FD) measures of structural connectivity	Change from Baseline structural connectivity at 10 weeks

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Principal Investigator: Karen J. Nolan, PhD, Kessler Foundation; Principal Investigator: Soha Saleh, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Gait Disorders, Neurologic
• Other Study ID Numbers: R-1073-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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