A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit

Paraplegia Clinical Trial

— RW  

Official title:

Study of the ReWalk Motorized Exoskeleton Suit That Enables Individuals With Lower Limbs Impairment to Walk and to Perform Other Basic Mobility Functions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627107
• Other study ID #: RW-002
• Status: Completed
• Phase: N/A
• First received: February 21, 2008
• Last updated: November 27, 2010
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: November 2010
• Source: Argo Medical Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Paraplegia
• SCI

Intervention

Device:
• ReWalk - a motorized exoskeleton suit
The subject will wear the ReWalk suit and have training sessions for walking with the device.

Locations

Country	Name	City	State
Israel	Sheba Medical Center, Neurological Rehabilitation Department	Tel-Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Argo Medical Technologies Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation and subject feedback		3 months	Yes
Secondary	subject tolerance		3 months	Yes