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Trial record 6 of 11 for:    rewalk

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
  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:


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:
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 April 21, 2017