Robotic Exoskeleton Assisted Gait Post Stroke

NCT ID: NCT04309305

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2026-09-01

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.

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.

Conditions

CVA; Gait, Hemiplegic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stroke RE

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.

Group Type: EXPERIMENTAL

EksoGT™, Ekso Bionics, Berkley, CA, USA

Intervention Type: 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 SOC

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard gait therapy provided by licensed physical therapists post stroke.

Healthy Control

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.

Group Type: OTHER

No Intervention

Intervention Type: OTHER

Testing Only

Interventions

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.

Intervention Type: DEVICE

Standard of Care

Standard gait therapy provided by licensed physical therapists post stroke.

Intervention Type: OTHER

No Intervention

Testing Only

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Karen J. Nolan, PhD

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen J. Nolan, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Soha Saleh, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Other Identifiers

R-1073-19

Identifier Type: -

Identifier Source: org_study_id