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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Cognitive Impairment; Gait Disorders, Neurologic; Motility Disorder
• Intervention / Treatment: Device: Robotic Exoskeleton Rehabilitation; Other: Conventional Gait Therapy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Contact: Ghaith J Androwis, Ph.D.; Phone Number: 973-324-3565; Email: gandrowis@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Exoskeleton Therapy; Gait rehabilitation provided using a wearable robotic exoskeleton	Device: Robotic Exoskeleton Rehabilitation; Participants will be randomly assigned to one of the two groups. Each participant will receive 8 sessions of gait rehabilitation and therapy via traditional therapy techniques of using the robotic exoskeleton. This training will be provided by a licensed physical therapist.
Active Comparator: Conventional Gait Therapy; Gait rehabilitation provided using traditional gait therapy under the supervision of a licensed PT	Other: Conventional Gait Therapy; Participants will be randomly assigned to one of the two groups. Each participant will receive 8 sessions of gait rehabilitation and therapy via traditional therapy techniques of using the robotic exoskeleton. This training will be provided by a licensed physical therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance walked in a specific time duration	The distance walked (meters) in 6 minutes is measured. This is following the 6-minute walk test (6MWT) procedure to measure walking endurance. The 6MWT is is a valid and reliable test of endurance walking performance in persons with MS. Participants are instructed to walk as fast and as far as possible for 6 minutes within a single corridor and performing 180° turns.	approximately 12 weeks
Neuropsychological measures of thinking	Processing speed and cognition outcomes, including: The Symbol Digit Modalities Test (SDMT) represents the primary CPS outcome in the current proposal. This test involves the conversion of a set of simple geometric designs into an oral response. It has been demonstrated to be sensitive to the presence of brain damage in numerous studies. The SDMT requires the examinee to substitute a number for a randomized presentation of a geometric figure. The appropriate number is shown in a key containing the Arabic numbers 1 through 9, each paired with a different geometric figure. The total number of correct responses in 90 seconds is the primary outcome of the SDMT.	approximately 12 weeks
Brain scans	Participants will undergo neuroimaging scans of the brain to acquire structural imaging of the brain using Magnetic resonance imaging (MRI). The MRI instrument that will be used is an FDA-approved Siemens Skyra 3T clinical imager housed in the Rocco Ortenzio Neuroimaging Center at Kessler Foundation.	approximately 12 weeks

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: Kessler Institute for Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Multiple Sclerosis; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: D-983-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes