TetraplegiaVRULTNCT06154122
Virtual Reality Upper Limb Therapy for People With Spinal Cord Injury
A study testing Virtual Reality Upper Limb Rehabilitation Games and Upper Limb Rehabilitation in people with Tetraplegia and Spinal Cord Injuries, run by Glasgow Caledonian University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetraplegia, Spinal Cord Injuries, Upper Extremity Paralysis
- What is being tested?
- Virtual Reality Upper Limb Rehabilitation Games and Upper Limb Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth National Spinal Injuries Unit (NHS Greater Glasgow and Clyde)
Glasgow, G51 4TF
About this study
Official title: The Feasibility of Virtual Reality-Based Activities for Upper Limb Rehabilitation of People With Acute/Sub-Acute Tetraplegia
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.
Read the detailed 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.
- Conditions
- Tetraplegia, Spinal Cord Injuries, Upper Extremity Paralysis
- Being tested
- Virtual Reality Upper Limb Rehabilitation Games, Upper Limb Rehabilitation
- Keywords
- Virtual Reality, Upper Extremities, Acute/Sub-acute Rehabilitation
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Upper Limb Rehabilitation GamesDevice
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 RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Upper Limb Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured over 12 weeks of participation.
Number of completed assessments
Completion of the assessments used at baseline, midpoint, and endpoint of the study.
Measured: 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: 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: 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: 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: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Completed at week 12 after the last VR session has been completed.
Secondary outcomes (5)
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.
- 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: Measured at baseline, 6 weeks, and 12 weeks.
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: Measured at baseline, 6 weeks, and 12 weeks.
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: Measured at baseline, 6 weeks, and 12 weeks.
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: Measured at baseline, 6 weeks, and 12 weeks.
Pain Intensity
Explore effectiveness of the VR-based upper limb rehabilitation intervention for people with tetraplegia during the acute, in-patient stage of rehabilitation.
- 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: Measured at baseline, 6 weeks, and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start15 Mar 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for TetraplegiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorna Paul, PhD, Principal investigator, Glasgow Caledonian UniversityMatthieu Poyade, PhD, Study chair, Glasgow School of Art
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154122
- Sponsor's protocol ID
- VRULT
- Acronym
- VRULT
- Status last verified
- Sep 2025
- First submitted
- 2 Nov 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in publications will be available at request to other researchers.
Publications
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.
PubMed 27834436van 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.
PubMed 30924706Anderson 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.
PubMed 15672628Anderson 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.
PubMed 34545013de 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.
PubMed 31828120Behrman 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.
PubMed 28628595Bickenbach, 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.
PubMed 18092558Buchholz 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.
PubMed 19767799Cragg J, Krassioukov A. Autonomic dysreflexia. CMAJ. 2012 Jan 10;184(1):66. doi: 10.1503/cmaj.110859. Epub 2011 Oct 11. No abstract available.
PubMed 21989470De 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.
PubMed 32630234Filipcic 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.
PubMed 34501739Gao, 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.
PubMed 36988416Itzkovich 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.
PubMed 17852230
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Virtual Reality-Based Activities for Upper Limb Rehabilitation of People With Acute/Sub-Acute Tetraplegia
- ClinicalTrials.gov ID
- NCT06154122
- Acronym / sponsor ID
- VRULT / VRULT
- Conditions
- Tetraplegia, Spinal Cord Injuries, Upper Extremity Paralysis
- Keywords
- Virtual Reality, Upper Extremities, Acute/Sub-acute Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Plus Treatment As Usual | Experimental | Device: Virtual Reality Upper Limb Rehabilitation Games, Other: Upper Limb Rehabilitation3 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). |
| Treatment As Usual | Active comparator | Other: Upper Limb RehabilitationUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Virtual Reality Upper Limb Rehabilitation GamesA 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. | Device | Virtual Reality Plus Treatment As Usual |
| Upper Limb RehabilitationUsual 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 | Treatment As Usual, Virtual Reality Plus Treatment As Usual |
Primary outcome
Number of VR Sessions Completed
Time frame: Measured over 12 weeks of participation.
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.
Time spent in VR
Time frame: Measured over 12 weeks of participation.
The time spent using the VR games, as recorded by the device. This will be measured in minutes and seconds.
Number of completed assessments
Time frame: Measured over 12 weeks of participation.
Completion of the assessments used at baseline, midpoint, and endpoint of the study.
Participant retention
Time frame: Measured over 12 weeks of participation.
The number of participants recruited to the study per month will be combined with eligibility and retention to determine overall recruitment and retention.
Participant recruitment rate per month
Time frame: Measured over 12 weeks of participation.
The number of participants recruited to the study per month will be combined with eligibility and retention to determine overall recruitment and retention.
Participant eligibility
Time frame: Measured over 12 weeks of participation.
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.
Adverse event monitoring and reporting
Time frame: Measured over 12 weeks of participation.
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.
Semi-structured Interviews
Time frame: Completed at week 12 after the last VR session has been completed.
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.
Usefulness, Satisfaction, and Ease of use Questionnaire (USE Questionnaire)
Time frame: Completed at week 12 after the last VR session has been completed.
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.
Handedness (Treatment Parameter)
Time frame: Completed at week 12 after the last VR session has been completed.
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.
Target Movement (Treatment Parameters)
Time frame: Completed at week 12 after the last VR session has been completed.
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.
Number of Repetitions (Treatment Parameters)
Time frame: Completed at week 12 after the last VR session has been completed.
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.
Choice of Game (Treatment Parameters)
Time frame: Completed at week 12 after the last VR session has been completed.
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.
Input Device choices (Treatment Parameters)
Time frame: Completed at week 12 after the last VR session has been completed.
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.
5 secondary outcomes
Motor Score
Time frame: Measured at baseline, 6 weeks, and 12 weeks.
Sensation
Time frame: Measured at baseline, 6 weeks, and 12 weeks.
Independence
Time frame: Measured at baseline, 6 weeks, and 12 weeks.
Hand/Upper Limb Function
Time frame: Measured at baseline, 6 weeks, and 12 weeks.
Pain Intensity
Time frame: Measured at baseline, 6 weeks, and 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 27834436Adriaansen 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.
- Background: PubMed 30924706van 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.
- Background: PubMed 15672628Anderson 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.
- Background: PubMed 34545013Anderson 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.
- Background: PubMed 31828120de 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.
- Background: PubMed 28628595Behrman 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.
- BackgroundBickenbach, 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: PubMed 18092558Bryce 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.
- Background: PubMed 19767799Buchholz 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.
- Background: PubMed 21989470Cragg J, Krassioukov A. Autonomic dysreflexia. CMAJ. 2012 Jan 10;184(1):66. doi: 10.1503/cmaj.110859. Epub 2011 Oct 11. No abstract available.
- Background: PubMed 32630234De 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.
- Background: PubMed 34501739Filipcic 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in publications will be available at request to other researchers.
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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.
Lorna Paul, PhD principal investigator
Glasgow Caledonian University
Matthieu Poyade, PhD study chair
Glasgow School of Art
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Upper Limb Rehabilitation Games and Upper Limb Rehabilitation in people with Tetraplegia and Spinal Cord Injuries, run by Glasgow Caledonian University at 1 site in United Kingdom.
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 6 inclusion and 5 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of VR Sessions Completed (time frame: Measured over 12 weeks of participation.). The study lists 14 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 NCT06154122, which also lists 31 linked publications.
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 22 Sep 2025.