Exoskeletons for Spinal Cord Injury: A Feasibility Study

NHS Trust

Status and phase

Unknown

Phase 4

Conditions

Spinal Cord Injury

Treatments

Device: ReWalk™ device

Study type

Interventional

Funder types

Other

Identifiers

NCT01943669

13/EE/0048 (UK NRES)

Details and patient eligibility

About

In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.

Full description

In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Twenty one-hour training sessions are scheduled for each participant over a 10-week period. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B & C (Lower Extremity Motor Score <20)
Motor level of injury from Cervical level 7 to Lumbar level 1, according to ASIA guidelines
Male and non-pregnant, non-lactating female
Age 18-55 years old
At least 12 months after injury
Able to stand or maintain upright position with or without using a standing device (e.g., 'Easy stand')
Able to sit with hips and knees ≥90° flexion
Height of 160 to 190 cm
Weight of <100 kg

Exclusion criteria

History of severe neurological injuries other than spinal cord injury (eg. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study
Unstable spine or unhealed limbs or pelvic fractures
Limited range of motion (<90°) hip and knee joints, including severe contractures
Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion or extension) or uncontrolled clonus
Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA.
Psychiatric or cognitive conditions that may interfere with the trial
Previous use of any exoskeletal robotic device
Patients incapable of providing informed consent