Exoskeletons for Spinal Cord Injury: A Feasibility Study

Spinal Cord Injury Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01943669
• Other study ID #: 13/EE/0048 (UK NRES)
• Status: Recruiting
• Phase: Phase 4
• First received: July 22, 2013
• Last updated: September 16, 2013
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Buckinghamshire Healthcare NHS Trust
• Contact: Joost J. van Middendorp, MD, PhD
• Phone: +44 1296 316783
• Email: Joost.vanMiddendorp[@]buckshealthcare.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• ReWalk™ device
Twenty one-hour ReWalk™ training sessions are scheduled for each participant over a 10-week period.

Locations

Country	Name	City	State
United Kingdom	National Spinal Injuries Centre, Stoke Mandeville Hospital	Aylesbury	Buckinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Buckinghamshire Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stair management	Exact timing pending learning curve, change in score in weeks up to 10 weeks.	10 weeks	No
Other	Obstacle course	Exact timing pending learning curve, change in score in weeks up to 10 weeks.	10 weeks	No
Primary	10-meter walking test (10MWT)	Change in score between 0 and 10 weeks.	10 weeks	No
Secondary	6-minutes walk test (6MWT)	Change in score between 0 and 10 weeks.	10 weeks	No
Secondary	Timed Up and Go (TUG) test	Change in score between 0 and 10 weeks.	10 weeks	No
Secondary	Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire	Change in score between 0 and 10 weeks.	10 weeks	No
Secondary	Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire	Change in score between 0 and 10 weeks.	10 weeks	No

External Links

•   Website directing to project description and updates