Robotic Exoskeleton Assisted Gait Post Stroke

Phase 1Enrolling By InvitationNCT04309305

Kessler Foundation75 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

CVA Gait, Hemiplegic

Interventions

EksoGT™, Ekso Bionics, Berkley, CA, USADEVICE

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 CareOTHER

Standard gait therapy provided by licensed physical therapists post stroke.

No InterventionOTHER

Testing Only

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kessler Foundation

West Orange, New Jersey, United States

Outcomes

Primary Outcomes

Functional Independence Measure (FIM) (aim 1)

a conventional assessment measure of motor function

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: Change from Baseline 6MWT at 10 weeks

TUG (aims 1-3)

Data from ClinicalTrials.gov

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