Status:
RECRUITING
Investigating the Effects of Wearable Robotic Exoskeleton for Improving Mobility and Cognition in Persons With MS
Lead Sponsor:
Kessler Foundation
Collaborating Sponsors:
Kessler Institute for Rehabilitation
Conditions:
Multiple Sclerosis
Gait Disorders, Neurologic
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Be diagnosed with multiple sclerosis.
- Be determined by the study staff to have moderate to severe difficulty walking but still be able to walk while using the robotic exoskeleton.
- Have some difficulty thinking and problem solving as determined by my performance on a special test that I will take during the screening visit.
- Be between the ages of 18 and 75.
- Be free from flair ups of my MS Symptoms for at least one month prior to testing.
- Discuss with study staff how to maintain a constant level of my spasticity medication (for example baclofen) throughout the study.
- Be able to walk (with the use of one or more assistive device if needed).
- Have English as my primary language.
- Be able to physically fit into the exoskeleton device: height between 60 and 76", weight under 220 lbs.
- Be able to tolerate upright standing for 30 minutes with assistance if needed.
- Have normal joint range of motion for walking as determined by study staff.
- Have sufficient strength to use the hemiwalker, bilateral canes or walker while wearing the RE.
- Have stable blood pressure.
- Be willing and able to give informed consent.
- Be able and willing to comply with study procedures and follow directions and commands, verbal instructions, and follow-up requirements.
Exclusion
- Have a history of head injury, stroke, seizures, or any other significant neurological history other than MS.
- Have a high degree of difficulty in thinking and problem solving that prevents me from participating in the study as determined by my performance on a special test taken during the screening visit.
- Be currently taking steroids, benzodiazepines, antipsychotics, and/or neuroleptics as determined by study staff review of my medications.
- Be pregnant.
- Be completely reliant on a wheelchair.
- Have joint contracture or spasticity of any limb that limits normal range of motion during walking with assistive devices as determined by study staff.
- Have skin issues that would prevent wearing the RE.
- Have pressure sore stage 2 or higher located in an area that would negatively affect weight bearing, harness fit, or therapist assistance.
- Have orthopedic issues or history that will interfere with walking or limit the range of motion of the lower limbs (e.g., knee replacement, inflammation)
- Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
- Have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the robotic device.
- Have a pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
- Have dental implants- I should discuss any dental implants with the investigators.
- Have been told by my doctor that it is unsafe for me to have a regular MRI as part of my medical care.
Key Trial Info
Start Date :
October 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04855825
Start Date
October 5 2017
End Date
December 30 2027
Last Update
November 24 2025
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052