A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit (RW)

ReWalk Robotics

Status: Completed

Conditions: SCI; Paraplegia

Treatments: Device: ReWalk - a motorized exoskeleton suit

Study type: Interventional

Funder types: Industry

Identifiers

NCT00627107

RW-002

Details and patient eligibility

About

The ReWalk enables people with lower limb disabilities to carry out routine ambulatory functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other severe walking impairments. The device promises to restore the dignity of disabled persons, enabling them to work and improve their general health and quality of life, as well as significantly reduce medical and other related expenses.

Full description

The ReWalk comprises light wearable brace support suit, which integrates DC motors at the joints, rechargeable batteries, an array of sensors and a computer-based control system. It is snugly fitted on the body and worn underneath the clothing, if desired. ReWalk is a new realization of the Powered Exoskeleton concept, first tried about fifty years ago with no success. Employing an innovative, non-robotic design approach, it uniquely matches the user's capabilities with the control mechanisms. Upper-body movements of the user are detected and used to initiate and maintain walking processes. User stability and safety during ambulation is secured by concurrent use of safety aids such as crutches for walking and railing for stairs.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic (at least 6 months after injury) complete cervical(C7-8) or thoracic (T1-T12) spinal cord injury
• Age between 18-55
• Male and non-pregnant non-lactating female
• Regular use of RGO or bing able to stand up using a device (e.g. EasyStand)
• under 100 kg and between 155-200 cm of height

Exclusion criteria

• History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc)
• Severe concurrent medical diseases: infections, heart or lung, pressure sores
• Unstable spine or unhealed limbs or pelvic fractures
• Psychiatric or cognitive situations that may interfere with the study

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

A

Experimental group

Description:

A group of paraplegics.

Treatment:

Device: ReWalk - a motorized exoskeleton suit