Spinal Cord InjuryRAPPER IINCT02417532
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
A study testing Rehabilitation using REX in people with Spinal Cord Injury, run by Rex Bionics Plc at 6 sites in 3 countries.
Trial summary
Prospective, Open label, single arm, non-randomized, non-comparative registry study of Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients with Spinal cord or other injury preventing unsupported patient ambulation. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Rehabilitation using REX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 6 sitesin 3 countries
- Study dates
- May 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Wheelchair user
- Spinal Injury Levels of C4 down to L5
- Has no outstanding skin integrity issues that could be effected by the REX device
- Should be between approximately 1.42m and 1.93m in height. More specifically, REX is able to accommodate the following limb lengths:
- Upper leg length : 380 - 470 mm
- Lower leg length : 366 - 470 mm
Show all 20Show fewer
- Heel position (Ankle to hind foot) : 40 - 92 mm
- Floor to ankle height (To be measured while wearing the shoe to be used for mobilising in REX) : 96 - 116 mm
- Has a skeletal hip width of 380 mm or less (limit imposed by REX)
- Is between 40 kg and 100 kg weight (limits imposed by REX)
- Has the manual dexterity to work a joystick
- Sufficient passive range of motion in the Hip, Knee and Ankle of at least
- Hip 90 degrees flexion 15 degrees hip extension 20 degrees abduction 16 degrees adduction
- Knee 0 degrees extension 93 degrees flexion
- Ankle 20 degrees dorsiflexion (with weight bearing and 10 degrees knee flexion) 22 degrees dorsiflexion (with 93 degrees knee flexion) 10 degrees plantar flexion 9 degrees inversion 9 degrees eversion
- Thigh lateral diameter of < 135 mm (230 mm above the knee joint line)
- Calf lateral diameter of < 100 mm (90 mm below the knee joint line)
- Manual dexterity to work a joystick with or without a T-Bar and use emergency stop button
- No contraindications to standing or mobilising
- Patients must choose to participate, and must have signed the informed consent document
Who cannot join
- Patients who do not meet inclusion criteria or physician discretion.
- Patients with history of impaired cardiac function who have been referred to and reviewed by a medical professional. With a decision made that they should not continue in the trial due to their impaired cardiac function.
- Patients contraindicated to walk or stand
- Patients with spinal injury outside Inclusion criteria
- Withdrawal or refusal to sign informed consent
- Any other contraindication based on physician discretion
- Known allergy (skin contact) to materials used in Rex
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United Kingdom3 sites
East Kent Hospitals University Foundation Trust
Canterbury, Kent, CT1 3NG
Physiofunction
Moulton, Northamptonshire, NN37rr
Royal National Orthopaedic Hospital NHS Trust
Stanmore, Middlesex, WD6 4QY
New Zealand2 sites
Rehabilitation Innovation Centre at AUT University
Auckland, 1010
Canterbury District Health Board, Burwood Hospital
Christchurch, 4708
About this study
Prospective, Open label, single arm, non-randomized, non-comparative registry study of Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients with Spinal cord or other injury preventing unsupported patient ambulation.
Read the detailed description
The objective of this feasibility study is to evaluate the overall device safety when used in Spinal Cord Injury Hospitals or Rehabilitation Centers under the supervision of a physician and/or qualified rehabilitation specialists.
- Conditions
- Spinal Cord Injury
- Being tested
- Rehabilitation using REX
- 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.
Rehabilitation using REXDevice
Exercises of wheelchair dependent subjects using REX
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation using REX | Experimental | Exercises using Rex mobility assist device Receives: Device: Rehabilitation using REX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Transfer
Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX
Measured: 1 day
Adverse Events
absence of unexpected serious adverse events
Measured: 1 day
Transfer Time
Time it took for participant to transfer into the Rex with or without supervision.
Measured: 1 day
Secondary outcomes (2)
Participant Satisfaction Questionnaire
overall user satisfaction with the device
Measured: 1 Day
Timed up and go Test- Ability to Stand From Chair
The number of seconds required to walk 3 m and turn around and walk back to the chair. (Functional test)
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rex Bionics Plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Generic Devices Consulting, Inc.
- Responsible party
- Sponsor
- Investigators
- Nicholas C Birch, FRCS, Principal investigator, The Chris Moody Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417532
- Sponsor's protocol ID
- RXPR-0001
- Acronym
- RAPPER II
- Status last verified
- Jul 2019
- First submitted
- 11 Apr 2015
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Birch N, Graham J, Priestley T, Heywood C, Sakel M, Gall A, Nunn A, Signal N. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid. J Neuroeng Rehabil. 2017 Jun 19;14(1):60. doi: 10.1186/s12984-017-0274-6.
PubMed 28629390
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
- ClinicalTrials.gov ID
- NCT02417532
- Acronym / sponsor ID
- RAPPER II / RXPR-0001
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Rex Bionics PlcIndustry (pharma, biotech, devices)
- Collaborators
- Generic Devices Consulting, Inc.
- Study start
- May 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Posted 17 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, Open label, single arm, non-randomized, non-comparative registry study of Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients with Spinal cord or other injury preventing unsupported patient ambulation.
Detailed description
The objective of this feasibility study is to evaluate the overall device safety when used in Spinal Cord Injury Hospitals or Rehabilitation Centers under the supervision of a physician and/or qualified rehabilitation specialists.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation using REX | Experimental | Device: Rehabilitation using REXExercises using Rex mobility assist device |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Wheelchair user
- Spinal Injury Levels of C4 down to L5
- Has no outstanding skin integrity issues that could be effected by the REX device
- Should be between approximately 1.42m and 1.93m in height. More specifically, REX is able to accommodate the following limb lengths:
- Upper leg length : 380 - 470 mm
Key exclusion criteria (7 listed)
- Patients who do not meet inclusion criteria or physician discretion.
- Patients with history of impaired cardiac function who have been referred to and reviewed by a medical professional. With a decision made that they should not continue in the trial due to their impaired cardiac function.
- Patients contraindicated to walk or stand
- Patients with spinal injury outside Inclusion criteria
- Withdrawal or refusal to sign informed consent
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 |
|---|---|---|
| Rehabilitation using REXExercises of wheelchair dependent subjects using REX | Device | Rehabilitation using REX |
Primary outcome
Ability to Transfer
Time frame: 1 day
Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX
Adverse Events
Time frame: 1 day
absence of unexpected serious adverse events
Transfer Time
Time frame: 1 day
Time it took for participant to transfer into the Rex with or without supervision.
2 secondary outcomes
Participant Satisfaction Questionnaire
Time frame: 1 Day
Timed up and go Test- Ability to Stand From Chair
Time frame: 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28629390Birch N, Graham J, Priestley T, Heywood C, Sakel M, Gall A, Nunn A, Signal N. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid. J Neuroeng Rehabil. 2017 Jun 19;14(1):60. doi: 10.1186/s12984-017-0274-6.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injury
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Recruiting
A Neuroprosthesis for Seated Posture and Balance
Spinal Cord Injury, Paralysis
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.
Nicholas C Birch, FRCS principal investigator
The Chris Moody Centre
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation using REX in people with Spinal Cord Injury, run by Rex Bionics Plc at 6 sites in 3 countries.
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 20 inclusion and 7 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: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, New Zealand, Australia. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to Transfer (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417532, which also lists 1 linked publication.
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 23 Jul 2019.