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
Abstract Background The RAPPER II study investigates the feasibility, safety and acceptability of using the REX self-stabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users. Feasibility is assessed by the completion of transfer into the REX device,...
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| Format: | Article |
| Language: | English |
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BMC
2017-06-01
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| Series: | Journal of NeuroEngineering and Rehabilitation |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12984-017-0274-6 |
| _version_ | 1811301386189537280 |
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| author | Nick Birch Jon Graham Tom Priestley Chris Heywood Mohamed Sakel Angela Gall Andrew Nunn Nada Signal |
| author_facet | Nick Birch Jon Graham Tom Priestley Chris Heywood Mohamed Sakel Angela Gall Andrew Nunn Nada Signal |
| author_sort | Nick Birch |
| collection | DOAJ |
| description | Abstract Background The RAPPER II study investigates the feasibility, safety and acceptability of using the REX self-stabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users. Feasibility is assessed by the completion of transfer into the REX device, competency in achieving autonomous control and completion of upper body exercise in an upright position in the REX device. Safety is measured by the occurrence of serious adverse events. Device acceptability is assessed with a user questionnaire. Methods RAPPER II is a prospective, multi-centre, open label, non-randomised, non-comparative cohort study in people with SCI recruited from neurological rehabilitation centres in the United Kingdom, Australia and New Zealand. This is the planned interim report of the first 20 participants. Each completed a transfer into the REX, were trained to achieve machine control and completed Timed Up and Go (TUG) tests as well as upper body exercises in standing in a single first time session. The time to achieve each task as well as the amount of assistance required was recorded. After finishing the trial tasks a User Experience questionnaire, exploring device acceptability, was completed. Results All participants could transfer into the REX. The mean transfer time was 439 s. Nineteen completed the exercise regime. Eighteen could achieve autonomous control of the REX, 17 of whom needed either no assistance or the help of just one therapist. Eighteen participants completed at least one TUG test in a mean time of 313 s, 15 with the assistance of just one therapist. The questionnaire demonstrated high levels of acceptability amongst users. There were no Serious Adverse Events. Conclusions This first interim analysis of RAPPER II shows that it is feasible and safe for people with SCI to use the REX powered assisted walking device to ambulate and exercise in. Participants with tetraplegia and paraplegia could walk and perform a functional exercise program when standing needing only modest levels of assistance in most cases. User acceptability was high. Trial registration ClinicalTrials.gov , NCT02417532 . Registered 11 April 2015. |
| first_indexed | 2024-04-13T07:07:56Z |
| format | Article |
| id | doaj.art-a856f858c4c04bf8acac6f1ca5a41119 |
| institution | Directory Open Access Journal |
| issn | 1743-0003 |
| language | English |
| last_indexed | 2024-04-13T07:07:56Z |
| publishDate | 2017-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of NeuroEngineering and Rehabilitation |
| spelling | doaj.art-a856f858c4c04bf8acac6f1ca5a411192022-12-22T02:56:56ZengBMCJournal of NeuroEngineering and Rehabilitation1743-00032017-06-0114111010.1186/s12984-017-0274-6Results 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 aidNick Birch0Jon Graham1Tom Priestley2Chris Heywood3Mohamed Sakel4Angela Gall5Andrew Nunn6Nada Signal7Consultant Spinal Specialist, The Chris Moody Rehabilitation Centre, Moulton CollegeConsultant Physiotherapist, PhysioFunction Ltd, The Chris Moody Rehabilitation Centre, Moulton CollegeResearch Manager, Rex Bionics PLCClinical Research Fellow, The Chris Moody Rehabilitation Centre, Moulton CollegeConsultant Physician and Director of NeuroRehabilitation, East Kent Hospitals University NHS Foundation TrustConsultant, London Spinal Cord Injury Centre, Royal National Orthopaedic HospitalMedical Director, Victorian Spinal Cord Service, Austin HospitalSenior Research Fellow, AUT UniversityAbstract Background The RAPPER II study investigates the feasibility, safety and acceptability of using the REX self-stabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users. Feasibility is assessed by the completion of transfer into the REX device, competency in achieving autonomous control and completion of upper body exercise in an upright position in the REX device. Safety is measured by the occurrence of serious adverse events. Device acceptability is assessed with a user questionnaire. Methods RAPPER II is a prospective, multi-centre, open label, non-randomised, non-comparative cohort study in people with SCI recruited from neurological rehabilitation centres in the United Kingdom, Australia and New Zealand. This is the planned interim report of the first 20 participants. Each completed a transfer into the REX, were trained to achieve machine control and completed Timed Up and Go (TUG) tests as well as upper body exercises in standing in a single first time session. The time to achieve each task as well as the amount of assistance required was recorded. After finishing the trial tasks a User Experience questionnaire, exploring device acceptability, was completed. Results All participants could transfer into the REX. The mean transfer time was 439 s. Nineteen completed the exercise regime. Eighteen could achieve autonomous control of the REX, 17 of whom needed either no assistance or the help of just one therapist. Eighteen participants completed at least one TUG test in a mean time of 313 s, 15 with the assistance of just one therapist. The questionnaire demonstrated high levels of acceptability amongst users. There were no Serious Adverse Events. Conclusions This first interim analysis of RAPPER II shows that it is feasible and safe for people with SCI to use the REX powered assisted walking device to ambulate and exercise in. Participants with tetraplegia and paraplegia could walk and perform a functional exercise program when standing needing only modest levels of assistance in most cases. User acceptability was high. Trial registration ClinicalTrials.gov , NCT02417532 . Registered 11 April 2015.http://link.springer.com/article/10.1186/s12984-017-0274-6Spinal cord injuryTetraplegiaParaplegiaPowered walking aidAssistive technologyPhysiotherapy, Rehabilitation, Robotics |
| spellingShingle | Nick Birch Jon Graham Tom Priestley Chris Heywood Mohamed Sakel Angela Gall Andrew Nunn Nada Signal 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 Journal of NeuroEngineering and Rehabilitation Spinal cord injury Tetraplegia Paraplegia Powered walking aid Assistive technology Physiotherapy, Rehabilitation, Robotics |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Spinal cord injury Tetraplegia Paraplegia Powered walking aid Assistive technology Physiotherapy, Rehabilitation, Robotics |
| url | http://link.springer.com/article/10.1186/s12984-017-0274-6 |
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