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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06154122
Other study ID # VRULT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date February 1, 2025

Study information

Verified date November 2023
Source Glasgow Caledonian University
Contact Lorna Paul, PhD
Phone +44 (0)141 331 8108
Email Lorna.Paul@gcu.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

A spinal cord injury (SCI) impacts nearly every aspect of a person's life. People with SCI will have muscular paralysis and loss of sensory and autonomic function below the level of their injury. Immediately following injury, people with SCI require acute in-patient care, during which rehabilitation is started. Following an SCI, people are at risk of pressure ulcers, urinary tract infections, spasticity, autonomic dysreflexia, depression, neuropathic pain, difficulty breathing, and circulatory problems. The multitude of impairments following SCI are associated with lower quality of life. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date February 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Device:
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.
Other:
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.

Locations

Country Name City State
United Kingdom Queen Elizabeth National Spinal Injuries Unit (NHS Greater Glasgow and Clyde) Glasgow

Sponsors (1)

Lead Sponsor Collaborator
Glasgow Caledonian University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (31)

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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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2023 Mar 29:1-13. doi: 10.1080/10790268.2023.2169062. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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* Note: There are 31 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary Completion of assessments Completion of the assessments used at baseline, midpoint, and endpoint of the study. Measured over 12 weeks of participation.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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 Motor Score Explore effectiveness of the VR-based upper limb rehabilitation intervention for people with tetraplegia during the acute, in-patient stage of rehabilitation.
Higher scores on the motor score indicate a better outcome, ranging between 0 and 50.
i. Motor score using the Upper Extremity Motor Score (UEMS) (Rupp et al., 2021).
Motor score, sensation, independence, hand/upper limb function, and pain measures will be use to explore effectiveness.
Measured at baseline, 6 weeks, and 12 weeks.
Secondary Sensation Explore effectiveness of the VR-based upper limb rehabilitation intervention for people with tetraplegia during the acute, in-patient stage of rehabilitation.
Higher scores on the light touch and pin prick scale indicate better outcomes, ranging between 0 and 112.
ii. Sensation (assess light touch and pin prick according to the ISNCSCI) (Rupp et al., 2021).
Motor score, sensation, independence, hand/upper limb function, and pain measures will be use to explore effectiveness.
Measured at baseline, 6 weeks, and 12 weeks.
Secondary Independence Explore effectiveness of the VR-based upper limb rehabilitation intervention for people with tetraplegia during the acute, in-patient stage of rehabilitation.
iii. Independence evaluated by the Spinal Cord Independence Measure (SCIM-III) (Itzkovich et al., 2007).
There are a total of 19 items on the SCIM III, which are divided into 3 subscales (self-care, respiration and sphincter management, and mobility). A total score out of 100 is achieved, with the subscales weighted as follows: self-care: scored 0-20; respiration and sphincter management: scored 0-40; and mobility: scored 0-40. Scores are higher in patients that require less assistance or fewer aids to complete basic activities of daily living and life support activities.
Motor score, sensation, independence, hand/upper limb function, and pain measures will be use to explore effectiveness.
Measured at baseline, 6 weeks, and 12 weeks.
Secondary Hand/Upper Limb Function iv. Hand/Upper Limb Function by the Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Subscales (Kalsi-Ryan et al., 2012).
Subtests of the GRASSP include manual muscle testing (which is graded on a scale of 0-5 for each selected muscle, with higher values representing greater muscle strength), sensation testing (which is graded on a scale of 0-4 for 3 areas, with higher scores representing greater sensation), prehension ability (which is scored on a scale of 0-4 for 3 grasp patterns with higher scores representing better ability to perform grasp with normal strength), and prehension performance (which is graded on a score of 0-5 for 4 different tasks, with higher scores representing better hand function).
Measured at baseline, 6 weeks, and 12 weeks.
Secondary Pain Intensity Explore effectiveness of the VR-based upper limb rehabilitation intervention for people with tetraplegia during the acute, in-patient stage of rehabilitation.
v. Pain measured on a Visual Analogue Scale.
A Visual Analogue Scale will be shown to participants, which is a 10 cm-long horizontal like with indices ranging from 0 to 10. The participant marks their current pain along the line. Higher scores represent a worse outcome, indicating higher pain at that specific timepoint.
Motor score, sensation, independence, hand/upper limb function, and pain measures will be use to explore effectiveness.
Measured at baseline, 6 weeks, and 12 weeks.
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