Clinical trial NCT01943669: Exoskeletons for Spinal Cord Injury: A Feasibility Study
Official title: An Open, Longitudinal, Prospective, Non-randomized, Self-Controlled Feasibility Study to Investigate the Effect of the ReWalk™ Device on Mobility Outcomes in Patients With Chronic Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Lead sponsor: Buckinghamshire Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 10-meter walking test (10MWT)
timeFrame: 10 weeks
Secondary outcomes:
measure: 6-minutes walk test (6MWT)
timeFrame: 10 weeks
measure: Timed Up and Go (TUG) test
timeFrame: 10 weeks
measure: Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire
timeFrame: 10 weeks
measure: Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire
timeFrame: 10 weeks
Other outcomes:
measure: Stair management
timeFrame: 10 weeks
measure: Obstacle course
timeFrame: 10 weeks
Locations:
city: Aylesbury
country: United Kingdom
facility: National Spinal Injuries Centre, Stoke Mandeville Hospital
state: Buckinghamshire
Study officials:
affiliation: Stoke Mandeville Spinal Foundation
name: Joost J. van Middendorp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: