Multiple Sclerosis Clinical Trial

Wearable Lower Extremity Exoskeleton to Promote Walking in Persons With Multiple Sclerosis

Summary

The purpose of this study is to investigate whether a wearable robotic exoskeleton can help people with multiple sclerosis (MS) to walk again.

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Full Description

Loss of the ability to walk is one of the significant problems in persons with multiple sclerosis (MS). This limitation prevents the person from having an active and meaningful life at home and in the community. Also, more energy is needed to walk, which can cause fatigue and further leads to a non-active life style and poor quality of life. Unfortunately, walking training is often not available for this population because of the severity and progress of the disease; therefore, a new strategy is needed to help people with MS to walk again. A new technology, the wearable robotic exoskeleton, has been developed to help persons with spinal cord injuries stand up and walk. The robotic legs are powered by batteries and controlled by motors. This study will investigate the use of a wearable robotic exoskeleton to help persons with MS to walk. Participants will receive trainings (5 days per week for 3 weeks) to walk with the robotic exoskeleton (EKSO, EKSO Bionics, Richmond, CA). During the training, a physical therapist will teach the participant how to maintain balance, sit to stand, stand to sit, and walk with the wearable robotic exoskeleton. The hypothesis is that persons with MS will be able to use a robotic exoskeleton to walk better and with less energy costs.

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Eligibility Criteria

Subjects will be enrolled if they meet the following inclusion criteria:

Age 18 years or older
Ambulatory with assistive devices (Ambulation status will be determined by the EDSS score)
With an Expanded Disability Status Scale (EDSS) score between 6 and 7.5 inclusive
Height and weight are between 160 and 188 cm (5'2'' to 6'2''), and less than 100 kg (220 lb), respectively (per exoskeleton manufacturer)
Able to follow simple 3 step commends
Able to understand the study procedure and consent form

Subjects will be excluded if they have any of the following exclusion criteria:

History of severe neurologic injuries other than MS (Spinal Cord Injury, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Cerebral Vascular Accident, etc.)

Severe comorbidities:

active infections
heart, lung, or circulatory conditions
pressure ulcers
Documented severe osteoporosis affecting the hip and spine
Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled clonus
Unhealed limb or pelvic fractures
Skin issues that would prevent wearing the device
Range of motion restrictions that would prevent subject from achieving a normal, reciprocal gait pattern, or would restrict a subject from completing normal sit to stand or stand to sit transitions.
Upper extremity strength deficits that limit ability to balance with a front rolling walker or crutches.
Heterotopic ossification that resists functional range of motion in lower extremities
Contractures (>15 degrees at the hips or >20 degrees at the knees)
Psychiatric or cognitive comorbidities resulting in motor planning or impulsivity concerns
Colostomy
Have received any physical therapy intervention within 3 months prior to enrolment in the study
Non-English speaking

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

11

Study ID:

NCT02519244

Recruitment Status:

Completed

Sponsor:

The University of Texas Health Science Center, Houston

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There is 1 Location for this study

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TIRR Memorial Hermann
Houston Texas, 77030, United States

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

11

Study ID:

NCT02519244

Recruitment Status:

Completed

Sponsor:


The University of Texas Health Science Center, Houston

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