Exoskeletons for Spinal Cord Injury: A Feasibility Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2013 by Buckinghamshire Healthcare NHS Trust.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Buckinghamshire Healthcare NHS Trust

ClinicalTrials.gov Identifier:

NCT01943669

First received: July 22, 2013

Last updated: September 16, 2013

Last verified: September 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Spinal Cord Injury	Device: ReWalk™ device	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
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.

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by Buckinghamshire Healthcare NHS Trust:

Primary Outcome Measures:

10-meter walking test (10MWT) [ Time Frame: 10 weeks ]
Change in score between 0 and 10 weeks.

Secondary Outcome Measures:

6-minutes walk test (6MWT) [ Time Frame: 10 weeks ]
Change in score between 0 and 10 weeks.
Timed Up and Go (TUG) test [ Time Frame: 10 weeks ]
Change in score between 0 and 10 weeks.
Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire [ Time Frame: 10 weeks ]
Change in score between 0 and 10 weeks.
Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire [ Time Frame: 10 weeks ]
Change in score between 0 and 10 weeks.

Other Outcome Measures:

Stair management [ Time Frame: 10 weeks ]
Exact timing pending learning curve, change in score in weeks up to 10 weeks.
Obstacle course [ Time Frame: 10 weeks ]
Exact timing pending learning curve, change in score in weeks up to 10 weeks.


Estimated Enrollment:	10
Study Start Date:	June 2013
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ReWalk™ device Self-controlled group; single cohort.	Device: ReWalk™ device Twenty one-hour ReWalk™ training sessions are scheduled for each participant over a 10-week period. Other Names: Exoskeleton Bionic suit

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


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943669

Contacts


Contact: Joost J. van Middendorp, MD, PhD	+44 1296 316783	Joost.vanMiddendorp@buckshealthcare.nhs.uk

Locations


United Kingdom
National Spinal Injuries Centre, Stoke Mandeville Hospital	Recruiting
Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
Contact: Joost J. van Middendorp, MD, PhD +44 1296316783 Joost.vanMiddendorp@buckshealthcare.nhs.uk
Principal Investigator: Joost J. van Middendorp, MD, PhD
Sub-Investigator: I Benson, BSc
Sub-Investigator: K Hart, BSc, MSc
Sub-Investigator: D Tussler, BSc, MSc

Sponsors and Collaborators

Buckinghamshire Healthcare NHS Trust

Investigators


Principal Investigator:	Joost J. van Middendorp, MD, PhD	Stoke Mandeville Spinal Foundation

More Information

Additional Information:

Website directing to project description and updates This link exits the ClinicalTrials.gov site


Responsible Party:	Buckinghamshire Healthcare NHS Trust
ClinicalTrials.gov Identifier:	NCT01943669 History of Changes
Other Study ID Numbers:	13/EE/0048 (UK NRES)
Study First Received:	July 22, 2013
Last Updated:	September 16, 2013

Keywords provided by Buckinghamshire Healthcare NHS Trust:


Spinal Cord Injury

Additional relevant MeSH terms:


Wounds and Injuries Spinal Cord Injuries Spinal Cord Diseases	Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System

ClinicalTrials.gov processed this record on July 17, 2017

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