Virtual Reality Upper Limb Therapy for People With Spinal Cord Injury

NCT06154122 | Completed

• 1 other identifier: VRULT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test if the VR games could be a form of upper limb rehabilitation for people with arm/hand problems due to SCI while they are in hospital. Participants who have had a spinal cord injury and have tetraplegia will be recruited from the Queen Elizabeth National Spinal Injuries Unit. After they have provided informed consent, they will receive 12 weeks of either standard upper limb therapy ('control group'), or both the VR activities and standard treatment ('VR Group'). Participants who receive VR activities will engage in immersive VR games that have been designed in co-production with people with tetraplegia and spinal cord injury specialists. The games aim to help participants improve the use of their arms and hands while they are undergoing primary rehabilitation within the Queen Elizabeth National Spinal Injuries Unit (QENSIU). The participants who are in the control group will receive their usual rehabilitation and will be given the opportunity to try the VR games after the completion of their involvement in the trial. 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.

Conditions

Tetraplegia; Spinal Cord Injuries; Upper Extremity Paralysis

Keywords

Virtual Reality; Upper Extremities; Acute/Sub-acute Rehabilitation

Outcome Measures

Primary Outcomes (14)

• Number of VR Sessions Completed

  The number of sessions of VR the participant completes. This will be recorded as an integer value from 0 to 3 per week of participation.

  Measured over 12 weeks of participation.

• Time spent in VR

  The time spent using the VR games, as recorded by the device. This will be measured in minutes and seconds.

  Measured over 12 weeks of participation.

• Number of completed assessments

  Completion of the assessments used at baseline, midpoint, and endpoint of the study.

  Measured over 12 weeks of participation.

• Participant retention

  The number of participants recruited to the study per month will be combined with eligibility and retention to determine overall recruitment and retention.

  Measured over 12 weeks of participation.

• Participant recruitment rate per month

  The number of participants recruited to the study per month will be combined with eligibility and retention to determine overall recruitment and retention.

  Measured over 12 weeks of participation.

• Participant eligibility

  Number of people approached about the study and the number of people who meet the inclusion and exclusion criteria. The number of participants recruited to the study per month will be combined with eligibility and retention to determine overall recruitment and retention.

  Measured over 12 weeks of participation.

• Adverse event monitoring and reporting

  Monitoring and reporting of any adverse events, either during or immediately following the VR intervention will be combined with results from semi-structured interviews and questionnaires to determine acceptability and usability.

  Measured over 12 weeks of participation.

• Semi-structured Interviews

  Determine the usability of the intervention through semi-structured interviews with participants and therapists. Monitoring and reporting of any adverse events, either during or immediately following the VR intervention will be combined with results from semi-structured interviews and questionnaires to determine acceptability and usability.

  Completed at week 12 after the last VR session has been completed.

• Usefulness, Satisfaction, and Ease of use Questionnaire (USE Questionnaire)

  Determine the usability of the intervention through questionnaire with participants and therapists (USE Questionnaire (Lund 2001)). This a 30-item survey. The maximum value for the USE Questionnaire is 210, and the minimum is 7. Participants can also respond 'not applicable' to all items. Higher scores mean a better outcome. Individual subscores of the USE Questionnaire can indicate that the system is or is not useful, satisfying, and/or easy to use.

  Completed at week 12 after the last VR session has been completed.

• Handedness (Treatment Parameter)

  The participant's choice of left, right, or both arm(s)/hand(s) will be recorded per session. Recording the treatment parameters the participant using VR selects during therapy to determine usability in combination with the interviews and questionnaires.

  Completed at week 12 after the last VR session has been completed.

• Target Movement (Treatment Parameters)

  The participant's choice of the type of movement they want to practise will be recorded per session. Movements will include wrist pronation/supination, elbow flexion/extension, and an integrated movement incorporating shoulder movement and elbow flexion and extension. Recording the treatment parameters the participant using VR selects during therapy to determine usability in combination with the interviews and questionnaires.

  Completed at week 12 after the last VR session has been completed.

• Number of Repetitions (Treatment Parameters)

  The number of repetitions of the target movement (see outcome 11) will be recorded per session. Recording the treatment parameters the participant using VR selects during therapy to determine usability in combination with the interviews and questionnaires.

  Completed at week 12 after the last VR session has been completed.

• Choice of Game (Treatment Parameters)

  The participant's choice of game will be recorded per session. Recording the treatment parameters the participant using VR selects during therapy to determine usability in combination with the interviews and questionnaires.

  Completed at week 12 after the last VR session has been completed.

• Input Device choices (Treatment Parameters)

  The participant's choice of input device will be recorded per session. Input devices available will include either the use of tracked hand-held controllers, or the use of an infrared-based 'hand-held controller-free' hand-tracking module. Recording the treatment parameters the participant using VR selects during therapy to determine usability in combination with the interviews and questionnaires.

  Completed at week 12 after the last VR session has been completed.

Secondary Outcomes (5)

• Motor Score

  Measured at baseline, 6 weeks, and 12 weeks.

• Sensation

  Measured at baseline, 6 weeks, and 12 weeks.

• Independence

  Measured at baseline, 6 weeks, and 12 weeks.

• Hand/Upper Limb Function

  Measured at baseline, 6 weeks, and 12 weeks.

• Pain Intensity

  Measured at baseline, 6 weeks, and 12 weeks.

Study Arms (2)

Virtual Reality Plus Treatment As Usual

EXPERIMENTAL

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).

Device: Virtual Reality Upper Limb Rehabilitation Games; Other: Upper Limb Rehabilitation

Treatment As Usual

ACTIVE COMPARATOR

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.

Other: Upper Limb Rehabilitation

Interventions

Virtual Reality Upper Limb Rehabilitation Games DEVICE

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.

Virtual Reality Plus Treatment As Usual

Upper Limb Rehabilitation OTHER

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; Virtual Reality Plus Treatment As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give informed consent for participation in the trial.
• 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.

You may not qualify if:

• Scheduled elective surgery or other procedures requiring general anaesthesia anticipated within the next 12 weeks.
• 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.

Sponsors & Collaborators

• Glasgow Caledonian University: lead

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit (NHS Greater Glasgow and Clyde)

Glasgow, G51 4TF, United Kingdom

Location

Related Publications (31)

• 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.

  PMID: 27834436 BACKGROUND

• 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.

  PMID: 30924706 BACKGROUND

• 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.

  PMID: 15672628 BACKGROUND

• 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.

  PMID: 34545013 BACKGROUND

• 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.

  PMID: 31828120 BACKGROUND

• 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.

  PMID: 28628595 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18092558 BACKGROUND

• 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.

  PMID: 19767799 BACKGROUND

• 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.

  PMID: 21989470 BACKGROUND

• 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.

  PMID: 32630234 BACKGROUND

• 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.

  PMID: 34501739 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 36988416 BACKGROUND

• 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.

  PMID: 17852230 BACKGROUND

• 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.

  PMID: 35349399 BACKGROUND

• 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.

  PMID: 21568688 BACKGROUND

• 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.

  PMID: 26560017 BACKGROUND

• 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.

  PMID: 34341881 BACKGROUND

• 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.

  PMID: 22647878 BACKGROUND

• 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.

  PMID: 36203293 BACKGROUND

• 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.

  PMID: 25575932 BACKGROUND

• 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.

  PMID: 32899665 BACKGROUND

• 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.

  PMID: 27809702 BACKGROUND

• 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.

  PMID: 26236547 BACKGROUND

• 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.

  PMID: 22920448 BACKGROUND

• 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.

  PMID: 34108832 BACKGROUND

• 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.

  PMID: 29619249 BACKGROUND

• 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.

  PMID: 33501115 BACKGROUND

• 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.

  PMID: 32046728 BACKGROUND

• 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.

  PMID: 31037223 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Lorna Paul, PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

• Matthieu Poyade, PhD

  Glasgow School of Art

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: December 1, 2023
• Study Start: March 15, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be stored on One Drive for 5 years, after which it will be deleted and CRFs will be shredded as confidential waste.
• Access Criteria: All IPD that underlie results in a publication will be available at request and stored on a Glasgow Caledonian University OneDrive account.

Locations

GB (1)