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ENROLLING BY INVITATION

NCT04309305

PHASE1

Robotic Exoskeleton Assisted Gait Post Stroke

Sponsor: Kessler Foundation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-01-30

Completion Date

2026-09-01

Last Updated

2025-04-06

Healthy Volunteers

Yes

Conditions

CVA Gait, Hemiplegic

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

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