Immersive Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis

Upper Limb Rehabilitation Using Immersive Virtual Reality for People With Multiple Sclerosis; a Feasibility Trial

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Immersive Virtual Reality Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G4 0BA
      • Amy Webster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Intervention; Eight weeks of two 30 minute sessions using virtual reality with the upper limb exercise games.	Other: Immersive Virtual Reality Intervention; Eight week intervention with two sessions a week. Each session will be 30 minutes in duration and will involve participants partaking in VR and such games include targeting individual finger movement (playing piano); grasp and release and one game (catching falling stars) includes holding a controller for elbow flexion and extension (Whack-a-mole).
No Intervention: Control Group; Participants will be asked to continue with their usual care independent of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rates	Recording the number of participants: identified and approached; number of participants that meet eligibility criteria or are excluded and record reasons for exclusion; number of participants that agree to take part in the study.	First 5 months of study.
Number of intervention sessions completed by participants	Measured by recording the amount of VR sessions completed and the duration of these for each participant.	Through the intervention period of 6 months.
Recording the number of drop out rates from participants	Measured by recording the amount of participants from both groups dropping out of the study.	Through the intervention period of 6 months.
Acceptance of being assigned to the control arm	Asking participants in the control arm if they accept being in this group rather than the intervention group.	Week 8 of intervention.
Reporting adverse effects from intervention.	Recording the number and type of adverse effects experienced by the participants from the intervention, either during or immediately following the VR intervention.	Through the intervention period of 6 months.
Rate of completion of secondary outcomes	Recording if participants are able to complete the upper limb related outcomes.	Through the intervention period of 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine Hole Peg Test	Measurement of hand dexterity.	Baseline, Week 4, Week 8
ABLIHAND questionnaire	Self-reported questionnaire regarding their ability to perform activities of daily living that requires upper limb function. It has a maximum score of 46 and the lower the score, the poorer the functional ability.	Baseline, Week 4, Week 8
Hand grip strength via Jamar dynamometer	Measurement of hand grip strength.	Baseline, Week 4, Week 8
Action Research Arm Test (ARAT)	Measurement of ability of handling objects and other general upper limb movements.	Baseline, Week 4, Week 8
The spasticity-related quality of life tool (SQoL-6D)	Self-reported questionnaire regarding how spasticity of their upper limb affects their quality of life. There are 7 domains and the participant has to tick which statement they believe is most appropriate to their spasticity within the last 7 days.	Baseline, Week 4, Week 8
USE questionnaire	Questionnaire regarding the user's opinion on the usefulness, satisfaction and ease of use of the developed software. There are 30 questions using a 7-point Likert scale the participant must rate how strongly they agree or disagree with the statements regarding the software.	Week 8
Semi-structured interviews	Interviews to explore the participant's experience with the virtual reality intervention, any issues encountered and suggested improvements for future studies using the games or virtual reality.	Week 9

Collaborators and Investigators

• Sponsor: Glasgow Caledonian University
• Collaborators: NHS Lanarkshire; MS Society, UK

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Multiple Sclerosis; Virtual reality
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 22/VRMS/115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share participant data to anyone outside the research team, however the results of this study will be reported and planned publication after the study is completed with anonymised data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No