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

Primary Purpose

Multiple Sclerosis, Gait Disorders, Neurologic, Motility Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic Exoskeleton Rehabilitation
Conventional Gait Therapy
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic Exoskeleton Therapy

Conventional Gait Therapy

Arm Description

Gait rehabilitation provided using a wearable robotic exoskeleton

Gait rehabilitation provided using traditional gait therapy under the supervision of a licensed PT

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 18, 2018
Last Updated
May 23, 2022
Sponsor
Kessler Foundation
Collaborators
Kessler Institute for Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT04855825
Brief Title
Investigating the Effects of Wearable Robotic Exoskeleton for Improving Mobility and Cognition in Persons With MS
Official Title
Investigating the Effects of Wearable Robotic Exoskeleton for Improving Mobility and Cognition in Persons With MS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
Collaborators
Kessler Institute for Rehabilitation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Gait Disorders, Neurologic, Motility Disorder, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic Exoskeleton Therapy
Arm Type
Experimental
Arm Description
Gait rehabilitation provided using a wearable robotic exoskeleton
Arm Title
Conventional Gait Therapy
Arm Type
Active Comparator
Arm Description
Gait rehabilitation provided using traditional gait therapy under the supervision of a licensed PT
Intervention Type
Device
Intervention Name(s)
Robotic Exoskeleton Rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Gait Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distance walked in a specific time duration
Description
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.
Time Frame
approximately 12 weeks
Title
Neuropsychological measures of thinking
Description
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.
Time Frame
approximately 12 weeks
Title
Brain scans
Description
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.
Time Frame
approximately 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghaith J Androwis, Ph.D.
Phone
973-324-3565
Email
gandrowis@kesslerfoundation.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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