Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04855825

Investigating the Effects of Wearable Robotic Exoskeleton for Improving Mobility and Cognition in Persons With MS

Led by Kessler Foundation · Updated on 2025-11-24

10

Participants Needed

1

Research Sites

534 weeks

Total Duration

On this page

Sponsors

K

Kessler Foundation

Lead Sponsor

K

Kessler Institute for Rehabilitation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this research study is to evaluate the usefulness of a wearable robotic exoskeleton device (Ekso-GT), to improve learning and memory, and gait therapy in persons with walking disability due to Multiple Sclerosis. The study will evaluate the mobility, learning and memory, and walking abilities of individuals with multiple sclerosis who went through the traditional as compared to others who used the robotic exoskeleton as part of their therapy.

CONDITIONS

Official Title

Investigating the Effects of Wearable Robotic Exoskeleton for Improving Mobility and Cognition in Persons With MS

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with multiple sclerosis.
  • Have moderate to severe difficulty walking but still able to walk using the robotic exoskeleton.
  • Have some difficulty with thinking and problem solving as determined by a screening test.
  • Aged between 18 and 75 years.
  • Free from MS symptom flare-ups for at least one month before testing.
  • Able to maintain a constant level of spasticity medication during the study.
  • Able to walk with or without assistive devices.
  • English is the primary language.
  • Physically fit to use the exoskeleton device: height between 60 and 76 inches, weight under 220 lbs.
  • Able to tolerate standing upright for 30 minutes with assistance if needed.
  • Have normal joint range of motion for walking.
  • Have sufficient strength to use a hemiwalker, bilateral canes, or walker while wearing the exoskeleton.
  • Have stable blood pressure.
  • Willing and able to give informed consent.
  • Able and willing to follow study procedures, instructions, and follow-up requirements.
Not Eligible

You will not qualify if you...

  • History of head injury, stroke, seizures, or other major neurological conditions besides MS.
  • Severe difficulty in thinking and problem solving preventing participation.
  • Currently taking steroids, benzodiazepines, antipsychotics, or neuroleptics.
  • Pregnant.
  • Completely reliant on a wheelchair.
  • Joint contracture or spasticity limiting normal walking range of motion.
  • Skin issues preventing wearing the robotic exoskeleton.
  • Pressure sores stage 2 or higher affecting weight bearing or device fit.
  • Orthopedic issues or history interfering with walking or joint motion (e.g., knee replacement).
  • Recent hospitalization for heart attack, heart surgery, or acute heart failure within 3 months.
  • Other medical conditions affecting ability to use the robotic device.
  • Have pacemaker, implanted electrical devices, brain stimulator, aneurysm clips, metallic prostheses, permanent eyeliner, implanted pumps, or shrapnel fragments.
  • Dental implants requiring discussion with investigators.
  • Doctor has advised against having a regular MRI as part of medical care.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kessler Foundation

West Orange, New Jersey, United States, 07052

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Investigating the Effects of Wearable Robotic Exoskeleton for Improving Mobility and Cognition in Persons With MS | DecenTrialz