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Enrolling by invitation NCT04309305

Robotic Exoskeleton Assisted Gait Post Stroke

Phase I Interventional CVA Gait, Hemiplegic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EksoGT™, Ekso Bionics, Berkley, CA, USA, Standard of Care, No Intervention.
Who it may be relevant to
Registry conditions: CVA, Gait, Hemiplegic. Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • Other Standard of Care
    Standard gait therapy provided by licensed physical therapists post stroke.
  • Other No Intervention
    Testing Only

Primary outcome measures

  • Functional Independence Measure (FIM) (aim 1) [Time frame: Change from Baseline FIM at 10 weeks]
  • Within-brain functional connectivity (aim 2) [Time frame: Change from Baseline Within-brain functional connectivity at 10 weeks]
  • TMS recruitment curve slope (aim 3) [Time frame: Change from Baseline TMS recruitment curve slope at 10 weeks]
  • electroencephalogram (EEG) (aim 3) [Time frame: Change from Baseline EEG at 10 weeks]
  • electromyography (EMG) (aim 3) [Time frame: Change from Baseline EMG at 10 weeks]
  • 10MWT (aims 1-3) [Time frame: Change from Baseline 10MWT at 10 weeks]
  • 6MWT (aims 1-3) [Time frame: Change from Baseline 6MWT at 10 weeks]
  • TUG (aims 1-3) [Time frame: Change from Baseline TUG at 10 weeks]
  • structural connectivity (aim 2) [Time frame: Change from Baseline structural connectivity at 10 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Kessler Foundation — West Orange

Identifiers

NCT: NCT04309305 · R-1073-19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗