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Clinical Trial: Robotic exoskeleton

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Details
Type of MS: PPMS|RRMS
Treatment mode of action: To improve mobility, memory and walking
Number of Subjects: 24
Medication: wearable robotic exoskeleton (RE) device, called Ekso-GT
Location: New Jersey
Institutions: Kessler Foundation and Kessler Institute for Rehabilitation (West Orange- NJ)
1199 Pleasant Valley Way
West Orange, NJ, 07052 Contact Information
Ghaith J. Androwis, Ph.D.
201-968-6110
gandrowis@kesslerfoundation.org

Funding:

Avidan Foundation

Description

The purpose of this research study is to evaluate the usefulness of a wearable robotic exoskeleton (RE) device, called Ekso-GT, to improve learning, memory and walking ability in persons with walking disability due to Multiple Sclerosis. The study will evaluate the mobility, learning and memory, and walking abilities of participants who are randomly assigned (like using a flip of a coin) to standard walking training as compared to those who are assigned to standard walking training plus walking training using the Ekso-GT.

Subjects' participation in this study will depend on which group he/she will be randomly assigned to and will go on for approximately 6 weeks or 11 weeks from the time of consent.       

Participants will be invited to an initial screening visit, a baseline assessment, and a post rehabilitation visit (after 4 weeks of therapy). If the participant is assigned to the 8-week therapy group, he/she will also participate in a second post rehabilitation assessment visit (after 8 weeks of therapy). The baseline and post rehabilitation assessments will each require 2 to 3 separate visits that will last about 2 hours each. 

Participants will be randomly assigned to one of four training programs (standard walking training for 4 weeks, standard walking training plus Ekso-GT for 4 weeks, standard walking training for 8 weeks, or standard walking training plus Ekso-GT for 8 weeks). Each training session will last approximately 60 minutes.  

While participants are part of this study, he/she will be asked to participate in a number of walking tests where he/she walks different distances at different speeds and a series of movement tests that measure their ability to reach for objects and my ability to push and pull.

Participants will also perform an exercise test on a piece of training equipment (stepping system, cycling bike or a treadmill) while he/she are connected to a device that analyses the gases the participant breathes out. On the same treadmill participants will also be tested on their ability to avoid virtual obstacles and the ability to follow visual targets presented to him/her.  Small sensors may be attached to their body during these tests to get information about my muscles, temperature, heart, respiration, joints, and movement. 

Participants will undergo paper and pencil tests examining my language skills, how fast they can process information, their ability to remember new information, pay attention for long periods of time, analyze patterns, etc. Participants will undergo MRI scans. He/she may undergo up to three MRI scans depending on which group they are assigned to. These scans are completed at baseline, after 4-weeks and after 8-weeks of training. 

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