Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04000373|
Recruitment Status : Not yet recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Gait Disorders, Neurologic||Device: Ekso GT™ exoskeleton||Not Applicable|
Powered exoskeletons are approved by the FDA to assist in the rehabilitation of persons with spinal cord injury and post-stroke hemiplegia. The investigator is aware of only one pilot study of a powered exoskeleton (ReWalk®) in multiple sclerosis (MS) which demonstrated some improvements in sitting, standing and walking posture when used consistently. The investigator is not aware of any study of the Ekso GT™ exoskeleton in MS.
This is a feasibility and safety study of using the Ekso GT™ exoskeleton for gait training in patients with relapsing or progressive MS and severe mobility limitations (EDSS 5-5 - 7.5). Preliminary efficacy outcomes on gait and walking will also be collected for the purpose of designing a larger clinical trial of the Ekso GT™ exoskeleton for gait training in patients with MS.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||uncontrolled pre-post intervention study of the use of the Ekso GT™exoskeleton in gait training in the MS population|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
gait training with exoskeleton device
uncontrolled pre-post intervention study of gait training using the Ekso GT™exoskeleton
Device: Ekso GT™ exoskeleton
The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits.
- Dropout rate [ Time Frame: 0-14 weeks ]Percentage of enrolled participants who drop out of the study before the end of the treatment period.
- Adverse events [ Time Frame: 0-14 weeks ]Number of participants with adverse events occurring during or between treatment sessions.
- Timed 25 Foot Walk [ Time Frame: 0-14 weeks ]Change in walking speed on the Timed 25 Foot Walk between baseline, end of treatment, and end of follow-up period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000373
|Contact: Research Nurse Coordinatoremail@example.com|
|Contact: Research Regulatory and QA Manager||216-444-5682||OCONNOK@ccf.org|
|United States, Ohio|
|Cleveland Clinic Neurological Institute Mellen Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Francois A Bethoux, MD||The Cleveland Clinic|