NCT04000373

Pilot Study of Powered Exoskeleton Use for Gait Rehabilitation in Individuals With Multiple Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigator plans to test the use of the Ekso Bionics® Gait Training (Ekso GT™) exoskeleton for gait training in MS patients. The device will solely be used in the clinic under direct supervision from a physical therapist. This is a small PI-initiated uncontrolled pilot study to gather safety and feasibility data on the exoskeleton in individuals with MS and walking impairment.

Detailed description

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.

Conditions

• Multiple Sclerosis
• Gait Disorders, Neurologic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-23
• Primary completion: 2020-01-09
• Completion: 2020-01-09
• First posted: 2019-06-27
• Last updated: 2022-06-27
• Results posted: 2020-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study