Kessler Foundation
West Orange, New Jersey, 07052, United States
Location status: Recruiting
NCT Number: NCT04855825
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
West Orange, New Jersey, 07052, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: approximately 12 weeks
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
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
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.
Kessler Foundation
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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