Clinical trial NCT06154122: Virtual Reality Upper Limb Therapy for People With Spinal Cord Injury
Official title: The Feasibility of Virtual Reality-Based Activities for Upper Limb Rehabilitation of People With Acute/Sub-Acute Tetraplegia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tetraplegia
Spinal Cord Injuries
Upper Extremity Paralysis
Keywords: Virtual Reality
Upper Extremities
Acute/Sub-acute Rehabilitation
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of VR Sessions Completed
timeFrame: Measured over 12 weeks of participation.
measure: Time spent in VR
timeFrame: Measured over 12 weeks of participation.
measure: Number of completed assessments
timeFrame: Measured over 12 weeks of participation.
measure: Participant retention
timeFrame: Measured over 12 weeks of participation.
measure: Participant recruitment rate per month
timeFrame: Measured over 12 weeks of participation.
measure: Participant eligibility
timeFrame: Measured over 12 weeks of participation.
measure: Adverse event monitoring and reporting
timeFrame: Measured over 12 weeks of participation.
measure: Semi-structured Interviews
timeFrame: Completed at week 12 after the last VR session has been completed.
measure: Usefulness, Satisfaction, and Ease of use Questionnaire (USE Questionnaire)
timeFrame: Completed at week 12 after the last VR session has been completed.
measure: Handedness (Treatment Parameter)
timeFrame: Completed at week 12 after the last VR session has been completed.
measure: Target Movement (Treatment Parameters)
timeFrame: Completed at week 12 after the last VR session has been completed.
measure: Number of Repetitions (Treatment Parameters)
timeFrame: Completed at week 12 after the last VR session has been completed.
measure: Choice of Game (Treatment Parameters)
timeFrame: Completed at week 12 after the last VR session has been completed.
measure: Input Device choices (Treatment Parameters)
timeFrame: Completed at week 12 after the last VR session has been completed.
Secondary outcomes:
measure: Motor Score
timeFrame: Measured at baseline, 6 weeks, and 12 weeks.
measure: Sensation
timeFrame: Measured at baseline, 6 weeks, and 12 weeks.
measure: Independence
timeFrame: Measured at baseline, 6 weeks, and 12 weeks.
measure: Hand/Upper Limb Function
timeFrame: Measured at baseline, 6 weeks, and 12 weeks.
measure: Pain Intensity
timeFrame: Measured at baseline, 6 weeks, and 12 weeks.
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth National Spinal Injuries Unit (NHS Greater Glasgow and Clyde)
Study officials:
affiliation: Glasgow Caledonian University
name: Lorna Paul, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glasgow School of Art
name: Matthieu Poyade, PhD
role: STUDY_CHAIR
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