Spinal Cord InjuryPhase 4NCT01943669
Exoskeletons for Spinal Cord Injury: A Feasibility Study
A Phase 4 study testing ReWalk™ device in people with Spinal Cord Injury, run by Buckinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- ReWalk™ device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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')
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- Able to sit with hips and knees ≥90° flexion
- Height of 160 to 190 cm
- Weight of <100 kg
Who cannot join
- 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.
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- Psychiatric or cognitive conditions that may interfere with the trial
- Previous use of any exoskeletal robotic device
- Patients incapable of providing informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
National Spinal Injuries Centre, Stoke Mandeville Hospital
Aylesbury, Buckinghamshire, HP21 8AL
Joost J. van Middendorp, MD, PhD, +44 1296316783, Joost.vanMiddendorp@buckshealthcare.nhs.uk
Joost J. van Middendorp, MD, PhD
About this study
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.
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- ReWalk™ device
- Keywords
- Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReWalk™ deviceDevice
Also called Exoskeleton, Bionic suit
Twenty one-hour ReWalk™ training sessions are scheduled for each participant over a 10-week period.
| Study group | Role | What they receive |
|---|---|---|
| ReWalk™ device | Experimental | Self-controlled group; single cohort. Receives: Device: ReWalk™ device |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-meter walking test (10MWT)
Change in score between 0 and 10 weeks.
Measured: 10 weeks
Secondary outcomes (4)
6-minutes walk test (6MWT)
Change in score between 0 and 10 weeks.
Measured: 10 weeks
Timed Up and Go (TUG) test
Change in score between 0 and 10 weeks.
Measured: 10 weeks
Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire
Change in score between 0 and 10 weeks.
Measured: 10 weeks
Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire
Change in score between 0 and 10 weeks.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buckinghamshire Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joost J. van Middendorp, MD, PhD, Principal investigator, Stoke Mandeville Spinal Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943669
- Sponsor's protocol ID
- 13/EE/0048 (UK NRES)
- Status last verified
- Sep 2013
- First submitted
- 22 Jul 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01943669
- Acronym / sponsor ID
- 13/EE/0048 (UK NRES)
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Buckinghamshire Healthcare NHS TrustUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReWalk™ device | Experimental | Device: ReWalk™ deviceSelf-controlled group; single cohort. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReWalk™ deviceAlso: Exoskeleton, Bionic suitTwenty one-hour ReWalk™ training sessions are scheduled for each participant over a 10-week period. | Device | ReWalk™ device |
Primary outcome
10-meter walking test (10MWT)
Time frame: 10 weeks
Change in score between 0 and 10 weeks.
4 secondary outcomes
6-minutes walk test (6MWT)
Time frame: 10 weeks
Timed Up and Go (TUG) test
Time frame: 10 weeks
Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire
Time frame: 10 weeks
Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Website directing to project description and updatesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost J. van Middendorp, MD, PhD principal investigator
Stoke Mandeville Spinal Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ReWalk™ device in people with Spinal Cord Injury, run by Buckinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joost J. van Middendorp, MD, PhD (+44 1296 316783, Joost.vanMiddendorp@buckshealthcare.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-meter walking test (10MWT) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.