Robotic Exoskeleton Assisted Gait Post Stroke

NCT04309305 | Enrolling By Invitation Phase 1 DMC FDA Device

• 1 other identifier: R-1073-19
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

CVA; Gait, Hemiplegic

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (3)

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.

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.

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.

Other: No Intervention

Interventions

EksoGT™, Ekso Bionics, Berkley, CA, USA DEVICE

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.

Stroke RE

Standard of Care OTHER

Standard gait therapy provided by licensed physical therapists post stroke.

Stroke SOC

No Intervention OTHER

Testing Only

Healthy Control

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Karen J. Nolan, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

• Soha Saleh, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: March 16, 2020
• Study Start: January 30, 2020
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)