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Exoskeletons for Spinal Cord Injury: A Feasibility Study

NCT ID: NCT01943669

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injury

Keywords

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Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ReWalk™ device

Self-controlled group; single cohort.

Group Type EXPERIMENTAL

ReWalk™ device

Intervention Type DEVICE

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

Interventions

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ReWalk™ device

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

Intervention Type DEVICE

Other Intervention Names

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Exoskeleton Bionic suit

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Buckinghamshire Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joost J. van Middendorp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stoke Mandeville Spinal Foundation

Locations

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National Spinal Injuries Centre, Stoke Mandeville Hospital

Aylesbury, Buckinghamshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Joost J. van Middendorp, MD, PhD

Role: CONTACT

Phone: +44 1296 316783

Email: [email protected]

Facility Contacts

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Joost J. van Middendorp, MD, PhD

Role: primary

Related Links

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http://www.smsf.org.uk/research%20introduction.htm

Website directing to project description and updates

Other Identifiers

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13/EE/0048 (UK NRES)

Identifier Type: -

Identifier Source: org_study_id