Investigating the Effects of Wearable Robotic Exoskeleton for Improving Mobility and Cognition in Persons With MS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKessler Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Robotic Exoskeleton Rehabilitation
DeviceParticipants 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.
Conventional Gait Therapy
Other interventionParticipants 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.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Robotic Exoskeleton TherapyExperimental treatment 1 intervention
Group B: Conventional Gait TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
approximately 12 weeks2
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.
Time frame
approximately 12 weeks3
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.
Time frame
approximately 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kessler Foundation
Lead sponsor
Kessler Institute for Rehabilitation
Collaborator
Source ClinicalTrials.gov