NCT01943669

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

July 22, 2013

Last Update Submit

September 16, 2013

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • 10-meter walking test (10MWT)

    Change in score between 0 and 10 weeks.

    10 weeks

Secondary Outcomes (4)

  • 6-minutes walk test (6MWT)

    10 weeks

  • Timed Up and Go (TUG) test

    10 weeks

  • Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire

    10 weeks

  • Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire

    10 weeks

Other Outcomes (2)

  • Stair management

    10 weeks

  • Obstacle course

    10 weeks

Study Arms (1)

ReWalk™ device

EXPERIMENTAL

Self-controlled group; single cohort.

Device: ReWalk™ device

Interventions

ReWalk™ deviceDEVICE

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

Also known as: Exoskeleton, Bionic suit
ReWalk™ device

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Spinal Injuries Centre, Stoke Mandeville Hospital

Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom

RECRUITING

Related Links

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Joost J. van Middendorp, MD, PhD

    Stoke Mandeville Spinal Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost J. van Middendorp, MD, PhD

CONTACT

+44 1296 316783Joost.vanMiddendorp@buckshealthcare.nhs.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2013

First Posted

September 17, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

GB(1)