Virtual Reality Upper Limb Therapy for People With Spinal Cord Injury
NCT ID: NCT06154122
Last Updated: 2025-09-22
Study Results
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Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2024-03-15
2025-08-01
Brief Summary
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This study will measure the feasibility (the 'primary outcome') and explore the effectiveness (the 'secondary outcome') of the VR intervention. Feasibility will be measured by recording how often the VR games are used and whether or not participants use the games for the full duration of the trial. Participants and therapists will be interviewed at the end of the trial.
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Detailed Description
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Reducing reliance on care and achieving higher levels of independence is a major goal for people with SCI. People with SCI can improve the motor power and therefore function of their paralysed limbs through rehabilitation. This enables people with SCI to carry out tasks which would otherwise require a carer. Dressing, bladder and bowel care, transferring in and out of a wheelchair, and feeding are activities that often require more assistance. The difficulty in carrying out these activities can be greatly reduced if people with SCI can recover function in the upper limbs. Even small improvements in limb function can have large effects on a people with SCI's independence.
For people with tetraplegia, where the injury affects all four limbs, improving upper limb function is a major focus of rehabilitation. People with tetraplegia reported improvement in hand and arm function as their highest priority for improvement compared to other rehabilitation targets. Improvements in upper limb function can be achieved through Activity-Based Therapy (ABT). ABT refers to any intervention that involves high intensity, repetitive exercises which target activity-dependent plasticity in spinal circuits. The improvements from ABT in upper limb function have greater effects on quality of life when compared to traditional physical interventions targeted above the level of injury. Exercise can alleviate symptoms of some secondary conditions which can positively impact on quality of life. Physical inactivity is often reported by spinal cord injured people, with limited access to exercise being just one of many barriers to active lifestyles. There is a clear need to improve the accessibility of therapy for people with SCI.
Virtual Reality (VR) technology used as an assistive device for upper limb rehabilitation has good potential for people with SCI during rehabilitation by facilitating greater adherence to therapy and increasing access to the most effective rehabilitation strategies for people with neurological disorders. However, currently only a few studies have investigated the use of VR in SCI rehabilitation of the upper limbs. Of these studies, most have reported positive outcomes.
Three systematic reviews on the use of VR after spinal cord injury have been published in the last few years. Overall the findings suggest that VR training can improve motor function and balance, reduce symptoms such as pain, and improve aerobic function. However, there were consistent limitations reported including a relatively small number of studies, small experimental samples, and no consensus on the optimal treatment parameters or technology employed. Furthermore, there were no studies that evaluated the use of VR in the acute phase following SCI when there is most potential for recovery.
VR can have positive psychological effects among people with an SCI such as increased self-confidence, motivation, and participation in therapy. ABT has been shown to improve function through neuromuscular recovery and increase participation in therapy. The principles of ABT which target motor improvement could be integrated into a VR intervention for upper limb rehabilitation, which could provide a promising and exciting option for people with SCI in early stages of recovery.
There are challenges in the delivery of ABT, such as the cost associated with using assistive devices, resources required to train staff, difficulty achieving sufficient dosage, factors such as motivation to engage in therapy, and access to therapy equipment. These challenges could be overcome by collaborating with people with SCI and their carers at the design stage of an intervention to impart valuable expertise about their chronic conditions, experiences of the acute phase recovery immediately following injury, and ideas about how to better manage rehabilitation. This intervention has been developed using co-production, where end-users (people with SCI and SCI therapists) were involved at every stage of the development process. This process can produce interventions that are highly accepted and efficacious.
The investigators have therefore developed a set of VR-based physical exercises for upper limb rehabilitation in collaboration with people with lived experience of tetraplegia and spinal cord injury specialists. VR will allow the participant to repeatedly experience engaging, fun, and motivating digital environments within which can be practised upper limb movements as an adjunct to standard upper limb rehabilitation. The aim of this randomised controlled feasibility study is to determine if this intervention is usable and acceptable for people with tetraplegia and therapists during acute rehabilitation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Virtual Reality Plus Treatment As Usual
3 sessions of virtual reality upper limb treatment for up to 30 minutes each will be administered each week for 12 weeks.
Participants randomised to the VR treatment arm will also receive treatment as usual for their upper limbs (see Treatment As Usual).
Virtual Reality Upper Limb Rehabilitation Games
A VR upper limb rehabilitation programme prescribed by the therapist with games chosen depending on the exercise task required and the level of difficulty adapted to the ability of the individual. The participant will use the VR system's user interface to navigate through menus to set their gameplay preferences and select which games to play.
The games of the intervention will involve facilitating and replicating upper limb movements including gross movements of the shoulder, such as rotation, abduction and addiction, movements of the upper and lower arms, such as flexion and extension of the elbow, and hand, wrist and finger movements, including wrist pronation supination, and finger flexion and extension, as well as tenodesis movements, grasping, and pinching.
Upper Limb Rehabilitation
Usual upper limb rehabilitation is delivered by occupational therapists and physiotherapists and aims to build strength of the upper limbs and optimise function. Patients receive hand therapy once per day and physiotherapy twice per day. Rehabilitation is highly individualised.
Treatment As Usual
Usual upper limb rehabilitation is delivered by occupational therapists and physiotherapists and aims to build strength of the upper limbs and optimise function. Patients receive hand therapy once per day and physiotherapy twice per day. Rehabilitation is highly individualised.
Upper Limb Rehabilitation
Usual upper limb rehabilitation is delivered by occupational therapists and physiotherapists and aims to build strength of the upper limbs and optimise function. Patients receive hand therapy once per day and physiotherapy twice per day. Rehabilitation is highly individualised.
Interventions
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Virtual Reality Upper Limb Rehabilitation Games
A VR upper limb rehabilitation programme prescribed by the therapist with games chosen depending on the exercise task required and the level of difficulty adapted to the ability of the individual. The participant will use the VR system's user interface to navigate through menus to set their gameplay preferences and select which games to play.
The games of the intervention will involve facilitating and replicating upper limb movements including gross movements of the shoulder, such as rotation, abduction and addiction, movements of the upper and lower arms, such as flexion and extension of the elbow, and hand, wrist and finger movements, including wrist pronation supination, and finger flexion and extension, as well as tenodesis movements, grasping, and pinching.
Upper Limb Rehabilitation
Usual upper limb rehabilitation is delivered by occupational therapists and physiotherapists and aims to build strength of the upper limbs and optimise function. Patients receive hand therapy once per day and physiotherapy twice per day. Rehabilitation is highly individualised.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or above.
* An in-patient at the Queen Elizabeth National Spinal Injuries Unit in Glasgow with a diagnosis of tetraplegia.
* Sustained a cervical spine injury (C4-C8).
* Medically stable to engage in physical rehabilitation and physical activity.
* Sitting up in a wheelchair for at least 2 hours daily.
Exclusion Criteria
* Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participated in another research trial involving an investigational product in the past 12 weeks.
* Participating in another research trial investigating upper limb rehabilitation interventions.
* Self-reported motion sickness.
18 Years
ALL
No
Sponsors
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Glasgow Caledonian University
OTHER
Responsible Party
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Principal Investigators
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Lorna Paul, PhD
Role: PRINCIPAL_INVESTIGATOR
Glasgow Caledonian University
Matthieu Poyade, PhD
Role: STUDY_CHAIR
Glasgow School of Art
Locations
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Queen Elizabeth National Spinal Injuries Unit (NHS Greater Glasgow and Clyde)
Glasgow, , United Kingdom
Countries
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References
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Adriaansen JJ, Ruijs LE, van Koppenhagen CF, van Asbeck FW, Snoek GJ, van Kuppevelt D, Visser-Meily JM, Post MW. Secondary health conditions and quality of life in persons living with spinal cord injury for at least ten years. J Rehabil Med. 2016 Nov 11;48(10):853-860. doi: 10.2340/16501977-2166.
van den Akker LE, Holla JFM, Dadema T, Visser B, Valent LJ, de Groot S, Dallinga JM, Deutekom M; WHEELS-study group. Determinants of physical activity in wheelchair users with spinal cord injury or lower limb amputation: perspectives of rehabilitation professionals and wheelchair users. Disabil Rehabil. 2020 Jul;42(14):1934-1941. doi: 10.1080/09638288.2019.1577503. Epub 2019 Mar 29.
Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
Anderson KD. Equitable partnerships between scientists and persons living with spinal cord injury will strengthen research scope, quality, and outcomes. Curr Opin Neurol. 2021 Dec 1;34(6):783-788. doi: 10.1097/WCO.0000000000000989.
de Araujo AVL, Neiva JFO, Monteiro CBM, Magalhaes FH. Efficacy of Virtual Reality Rehabilitation after Spinal Cord Injury: A Systematic Review. Biomed Res Int. 2019 Nov 13;2019:7106951. doi: 10.1155/2019/7106951. eCollection 2019.
Behrman AL, Ardolino EM, Harkema SJ. Activity-Based Therapy: From Basic Science to Clinical Application for Recovery After Spinal Cord Injury. J Neurol Phys Ther. 2017 Jul;41 Suppl 3(Suppl 3 IV STEP Spec Iss):S39-S45. doi: 10.1097/NPT.0000000000000184.
Bickenbach, J. et al. (2013) 'Chapter 4: Health care and rehabilitation needs.', in International perspectives on spinal cord injury / edited by Jerome Bickenbach. Geneva: World Health Organization, pp. 67-91.
Bryce TN, Budh CN, Cardenas DD, Dijkers M, Felix ER, Finnerup NB, Kennedy P, Lundeberg T, Richards JS, Rintala DH, Siddall P, Widerstrom-Noga E. Pain after spinal cord injury: an evidence-based review for clinical practice and research. Report of the National Institute on Disability and Rehabilitation Research Spinal Cord Injury Measures meeting. J Spinal Cord Med. 2007;30(5):421-40. doi: 10.1080/10790268.2007.11753405.
Buchholz AC, Martin Ginis KA, Bray SR, Craven BC, Hicks AL, Hayes KC, Latimer AE, McColl MA, Potter PJ, Wolfe DL. Greater daily leisure time physical activity is associated with lower chronic disease risk in adults with spinal cord injury. Appl Physiol Nutr Metab. 2009 Aug;34(4):640-7. doi: 10.1139/H09-050.
Cragg J, Krassioukov A. Autonomic dysreflexia. CMAJ. 2012 Jan 10;184(1):66. doi: 10.1503/cmaj.110859. Epub 2011 Oct 11. No abstract available.
De Miguel-Rubio A, Rubio MD, Salazar A, Camacho R, Lucena-Anton D. Effectiveness of Virtual Reality on Functional Performance after Spinal Cord Injury: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Jul 1;9(7):2065. doi: 10.3390/jcm9072065.
Filipcic T, Sember V, Pajek M, Jerman J. Quality of Life and Physical Activity of Persons with Spinal Cord Injury. Int J Environ Res Public Health. 2021 Aug 30;18(17):9148. doi: 10.3390/ijerph18179148.
Gao, M., Kortum, P. and Oswald, F. (2018) 'Psychometric Evaluation of the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire for Reliability and Validity', Proceedings of the Human Factors and Ergonomics Society Annual Meeting, 62(1), pp. 1414-1418. Available at: https://doi.org/10.1177/1541931218621322.
Hoekstra F, Gainforth HL, Broeksteeg R, Corras S, Collins D, Gaudet S, Giroux EE, McCallum S, Ma JK, Rakiecki D, Rockall S, van den Berg-Emons R, van Vilsteren A, Wilroy J, Martin Ginis KA. Theory- and evidence-based best practices for physical activity counseling for adults with spinal cord injury. J Spinal Cord Med. 2024 Jul;47(4):584-596. doi: 10.1080/10790268.2023.2169062. Epub 2023 Mar 29.
Itzkovich M, Gelernter I, Biering-Sorensen F, Weeks C, Laramee MT, Craven BC, Tonack M, Hitzig SL, Glaser E, Zeilig G, Aito S, Scivoletto G, Mecci M, Chadwick RJ, El Masry WS, Osman A, Glass CA, Silva P, Soni BM, Gardner BP, Savic G, Bergstrom EM, Bluvshtein V, Ronen J, Catz A. The Spinal Cord Independence Measure (SCIM) version III: reliability and validity in a multi-center international study. Disabil Rehabil. 2007 Dec 30;29(24):1926-33. doi: 10.1080/09638280601046302. Epub 2007 Mar 5.
Jervis Rademeyer H, Gauthier C, Zariffa J, Walden K, Jeji T, McCullum S, Musselman KE. Using activity-based therapy for individuals with spinal cord injury or disease: Interviews with physical and occupational therapists in rehabilitation hospitals. J Spinal Cord Med. 2023 Mar;46(2):298-308. doi: 10.1080/10790268.2022.2039855. Epub 2022 Mar 29.
Kalsi-Ryan S, Beaton D, Curt A, Duff S, Popovic MR, Rudhe C, Fehlings MG, Verrier MC. The Graded Redefined Assessment of Strength Sensibility and Prehension: reliability and validity. J Neurotrauma. 2012 Mar 20;29(5):905-14. doi: 10.1089/neu.2010.1504. Epub 2011 Aug 12.
Kalsi-Ryan S, Beaton D, Ahn H, Askes H, Drew B, Curt A, Popovic MR, Wang J, Verrier MC, Fehlings MG. Responsiveness, Sensitivity, and Minimally Detectable Difference of the Graded and Redefined Assessment of Strength, Sensibility, and Prehension, Version 1.0. J Neurotrauma. 2016 Feb 1;33(3):307-14. doi: 10.1089/neu.2015.4217. Epub 2015 Dec 17.
Kazim SF, Bowers CA, Cole CD, Varela S, Karimov Z, Martinez E, Ogulnick JV, Schmidt MH. Corticospinal Motor Circuit Plasticity After Spinal Cord Injury: Harnessing Neuroplasticity to Improve Functional Outcomes. Mol Neurobiol. 2021 Nov;58(11):5494-5516. doi: 10.1007/s12035-021-02484-w. Epub 2021 Aug 3.
Kramer JL, Lammertse DP, Schubert M, Curt A, Steeves JD. Relationship between motor recovery and independence after sensorimotor-complete cervical spinal cord injury. Neurorehabil Neural Repair. 2012 Nov-Dec;26(9):1064-71. doi: 10.1177/1545968312447306. Epub 2012 May 30.
Lewis NE, Tabarestani TQ, Cellini BR, Zhang N, Marrotte EJ, Wang H, Laskowitz DT, Abd-El-Barr MM, Faw TD. Effect of Acute Physical Interventions on Pathophysiology and Recovery After Spinal Cord Injury: A Comprehensive Review of the Literature. Neurospine. 2022 Sep;19(3):671-686. doi: 10.14245/ns.2244476.238. Epub 2022 Sep 30.
Lu X, Battistuzzo CR, Zoghi M, Galea MP. Effects of training on upper limb function after cervical spinal cord injury: a systematic review. Clin Rehabil. 2015 Jan;29(1):3-13. doi: 10.1177/0269215514536411. Epub 2014 Jun 4.
Miguel-Rubio A, Rubio MD, Salazar A, Moral-Munoz JA, Requena F, Camacho R, Lucena-Anton D. Is Virtual Reality Effective for Balance Recovery in Patients with Spinal Cord Injury? A Systematic Review and Meta-Analysis. J Clin Med. 2020 Sep 4;9(9):2861. doi: 10.3390/jcm9092861.
Quel de Oliveira C, Refshauge K, Middleton J, de Jong L, Davis GM. Effects of Activity-Based Therapy Interventions on Mobility, Independence, and Quality of Life for People with Spinal Cord Injuries: A Systematic Review and Meta-Analysis. J Neurotrauma. 2017 May 1;34(9):1726-1743. doi: 10.1089/neu.2016.4558. Epub 2016 Dec 20.
Dolbow DR, Gorgey AS, Recio AC, Stiens SA, Curry AC, Sadowsky CL, Gater DR, Martin R, McDonald JW. Activity-Based Restorative Therapies after Spinal Cord Injury: Inter-institutional conceptions and perceptions. Aging Dis. 2015 Aug 1;6(4):254-61. doi: 10.14336/AD.2014.1105. eCollection 2015 Aug.
Roy RR, Harkema SJ, Edgerton VR. Basic concepts of activity-based interventions for improved recovery of motor function after spinal cord injury. Arch Phys Med Rehabil. 2012 Sep;93(9):1487-97. doi: 10.1016/j.apmr.2012.04.034.
Rupp R, Biering-Sorensen F, Burns SP, Graves DE, Guest J, Jones L, Read MS, Rodriguez GM, Schuld C, Tansey-Md KE, Walden K, Kirshblum S. International Standards for Neurological Classification of Spinal Cord Injury: Revised 2019. Top Spinal Cord Inj Rehabil. 2021 Spring;27(2):1-22. doi: 10.46292/sci2702-1. No abstract available.
Savic G, Frankel HL, Jamous MA, Soni BM, Charlifue S. Participation restriction and assistance needs in people with spinal cord injuries of more than 40 year duration. Spinal Cord Ser Cases. 2018 Mar 27;4:28. doi: 10.1038/s41394-018-0056-9. eCollection 2018.
Schiza E, Matsangidou M, Neokleous K, Pattichis CS. Virtual Reality Applications for Neurological Disease: A Review. Front Robot AI. 2019 Oct 16;6:100. doi: 10.3389/frobt.2019.00100. eCollection 2019.
Slattery P, Saeri AK, Bragge P. Research co-design in health: a rapid overview of reviews. Health Res Policy Syst. 2020 Feb 11;18(1):17. doi: 10.1186/s12961-020-0528-9.
Yeo E, Chau B, Chi B, Ruckle DE, Ta P. Virtual Reality Neurorehabilitation for Mobility in Spinal Cord Injury: A Structured Review. Innov Clin Neurosci. 2019 Jan 1;16(1-2):13-20.
Provided Documents
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Document Type: Study Protocol
Related Links
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Meta (2023) 'Meta Quest 2 Technical Specifications'. Meta Platforms, Inc. Available at: https://www.meta.com/gb/quest/products/quest-2/tech-specs/#tech-specs.
Other Identifiers
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VRULT
Identifier Type: -
Identifier Source: org_study_id
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