NCT04855825 · Kessler Foundation
Investigating the Effects of Wearable Robotic Exoskeleton for Improving Mobility and Cognition in Persons With MS
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- West Orange, New Jersey
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 24, 2025 · Source of record for eligibility and locations