Clinical trial NCT05320237: Immersive Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis
Official title: Upper Limb Rehabilitation Using Immersive Virtual Reality for People With Multiple Sclerosis; a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Rehabilitation
Virtual reality
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: MS Society, UK
name: NHS Lanarkshire
First posted: 2022-04-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Virtual reality (VR) has reported benefits of engagement, immersion, and motivation in rehabilitation and has been proposed to be a solution for long-term engaging rehabilitation methods. However, the use of VR within the multiple sclerosis (MS) population is not widely investigated, and even less with regards to upper limb function. The main aim of this study is to assess the feasibility of using the Oculus Quest VR headset and games for improving upper limb function within the MS population. Recruited people with MS will be randomly assigned to either an eight week intervention using VR games that have been designed by co-production with people with MS and MS-specialists; or to a control group of usual care. All participants will undertake testing at baseline, four weeks and eight weeks for multiple outcomes measures related to upper limb and motor function. After completion of the intervention, participants who undertook VR intervention will complete a survey regarding the usability of the games, and some individuals will be invited to interviews to express their experience of using VR and any suggestions for improvement for potential future trials.

Detailed description: The aim of this study is to investigate the feasibility of an eight-week intervention of co-produced virtual reality (VR) games delivered using the Oculus Quest for improving the upper limb function of people with MS. This study is also a randomised controlled trial with two arms, one group will undergo the intervention using VR and the other will be a control group.

This study aims to recruit up to 30 people with MS who have some degree of self-reported upper limb mobility difficulties from MS clinics in NHS Lanarkshire and MS Revive, a third sector in Glasgow. Participants will be randomly allocated to a group: an eight week intervention study using VR and exercise games or a control group of usual care. All groups will have assessments at baseline, week 4 and week 8. However, only the VR intervention group will undertake the USE questionnaire and only a select number of participants in the VR group will participate in the semi-structured interviews.

The VR intervention group will involve participants travelling to a research site twice a week for eight weeks and each session will be approximately 30 minutes. This 30-minute intervention will include participating in game play and the participant using the game's interface (e.g. navigating through menus, selecting which games to play). The games for the intervention will involve facilitating and replicating upper limb movements: pushing buttons for the interface; individual finger movement; grasp and release and one game includes holding a controller for elbow flexion and extension (see table). The intervention group will undergo exercises in a fully immersive VR environment using the Oculus Quest VR headsets. For health and safety reasons participants will complete their programme whilst seated.

The control group will not receive a specific exercise programme but will be asked to continue with their usual care, which could generally include any ongoing physiotherapy or occupational therapy support or none whatsoever. Any ongoing physiotherapy or occupational therapy (NHS or non-NHS) will be recorded, detailing the exercises and frequency. After completion of the week 8 assessment, participants within the control group will be offered the opportunity to take part in a 30-minute session trialling the VR games.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of multiple sclerosis.
* Degree of self-reported hand or upper limb impairment which interferes with some activities of daily living (ADL) (e.g. dressing, eating, grooming).
* Objective upper limb impairment, in at least one hand, as determined by a Nine Hole Peg Test (see Section Outcome Measures) of 2 standard deviations of more above the published normative values depending on age and sex.
* Must be able to travel to a research site.

Exclusion Criteria:

* If they have had a relapse in the last three months
* Subjective cognitive problems resulting in them being unable to use the equipment or participate in virtual reality.
* Visual problems such that they cannot see the visual display within the headset (this does not include participants who have glasses that are enough to correct eyesight issues)
* Have a current eye infection.
* Have any significant co-existing neurological or orthopaedic conditions affecting the upper limb.
* Are unable to understand verbal or written explanations of the study or are unable to speak or understand English.
* Individuals who are currently enrolled in any clinical trials will be excluded, but those who have previously taken part in research and other trials will be eligible.

Primary outcomes:
measure: Recruitment Rates
timeFrame: First 5 months of study.
measure: Number of intervention sessions completed by participants
timeFrame: Through the intervention period of 6 months.
measure: Recording the number of drop out rates from participants
timeFrame: Through the intervention period of 6 months.
measure: Acceptance of being assigned to the control arm
timeFrame: Week 8 of intervention.
measure: Reporting adverse effects from intervention.
timeFrame: Through the intervention period of 6 months.
measure: Rate of completion of secondary outcomes
timeFrame: Through the intervention period of 6 months.
Secondary outcomes:
measure: Nine Hole Peg Test
timeFrame: Baseline, Week 4, Week 8
measure: ABLIHAND questionnaire
timeFrame: Baseline, Week 4, Week 8
measure: Hand grip strength via Jamar dynamometer
timeFrame: Baseline, Week 4, Week 8
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline, Week 4, Week 8
measure: The spasticity-related quality of life tool (SQoL-6D)
timeFrame: Baseline, Week 4, Week 8
measure: USE questionnaire
timeFrame: Week 8
measure: Semi-structured interviews
timeFrame: Week 9
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Amy Webster
state: Scotland
Study officials:
References: