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

NCT ID: NCT02519244

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-02-06

Brief Summary

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

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Robot-assisted rehabilitation

Subjects will participate in individualized locomotion training sessions using wearable lower limb exoskeleton, Ekso®. Each training session will last up to 60 minutes, 5 days per week for 3 weeks, for a total of 15 sessions. During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit.

Group Type: EXPERIMENTAL

Ekso® (Wearable lower limb exoskeleton)

Intervention Type: DEVICE

The wearable lower limb exoskeleton is a powered, robotic lower limb exoskeleton with actuated hips and knees. A control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.

Interventions

Ekso® (Wearable lower limb exoskeleton)

The wearable lower limb exoskeleton is a powered, robotic lower limb exoskeleton with actuated hips and knees. A control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

Texas Woman's University

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Shuo-Hsiu Chang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuo-Hsiu Chang, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

TIRR Memorial Hermann

Houston, Texas, United States

Countries

United States

References

Afzal T, Tseng SC, Lincoln JA, Kern M, Francisco GE, Chang SH. Exoskeleton-assisted Gait Training in Persons With Multiple Sclerosis: A Single-Group Pilot Study. Arch Phys Med Rehabil. 2020 Apr;101(4):599-606. doi: 10.1016/j.apmr.2019.10.192. Epub 2019 Dec 7.

Reference Type: DERIVED

PMID: 31821798 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PP3394

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSC-MS-15-0278

Identifier Type: -

Identifier Source: org_study_id