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Enrolling by Invitation

NCT Number: NCT04309305

Robotic Exoskeleton Assisted Gait 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.

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Key information

Conditions

CVA Gait Disorders, Neurologic Gait, Hemiplegic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard of care

Other

Standard gait therapy provided by licensed physical therapists post stroke.

No intervention

Other

Testing Only

Primary outcomes

  1. Functional Independence Measure (FIM) (aim 1)

    Time frame: Change from Baseline FIM at 10 weeks

    a conventional assessment measure of motor function

  2. Within-brain functional connectivity (aim 2)

    Time frame: Change from Baseline Within-brain functional connectivity at 10 weeks

    fMRI connectivity between selected regions of interest within the sensorimotor and attention networks.

  3. TMS recruitment curve slope (aim 3)

    Time frame: Change from Baseline TMS recruitment curve slope at 10 weeks

    A recruitment curve created using measure of primary motor cortex Motor Evoked Potential (MEP) at several stimulation thresholds.

  4. electroencephalogram (EEG) (aim 3)

    Time frame: Change from Baseline EEG at 10 weeks

    a measure of brain activation at different phases of gait cycle (swing versus double support).

  5. electromyography (EMG) (aim 3)

    Time frame: Change from Baseline EMG at 10 weeks

    a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).

  6. 10MWT (aims 1-3)

    Time frame: Change from Baseline 10MWT at 10 weeks

    10 meters walking test to evaluate walking speedafter stroke and in response to the intervention.

  7. 6MWT (aims 1-3)

    Time frame: Change from Baseline 6MWT at 10 weeks

    6 minutes walking test to evaluate endurancein connectivity after stroke and in response to the intervention.

  8. TUG (aims 1-3)

    Time frame: Change from Baseline TUG at 10 weeks

    time up and go (TUG) test

  9. structural connectivity (aim 2)

    Time frame: Change from Baseline structural connectivity at 10 weeks

    Diffusion Tensor Imaging (DTI) and fractal dimensions (FD) measures of structural connectivity

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

Functional and Neurophysiological Effects of a Progressive Robot Assisted Gait Intervention Early Post Stroke

Acronym: RE-Assist

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2020
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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