Immersive Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis

NCT05320237 | Completed

• 1 other identifier: 22/VRMS/115
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Rehabilitation; Virtual reality

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Nine Hole Peg Test

  Baseline, Week 4, Week 8

• ABLIHAND questionnaire

  Baseline, Week 4, Week 8

• Hand grip strength via Jamar dynamometer

  Baseline, Week 4, Week 8

• Action Research Arm Test (ARAT)

  Baseline, Week 4, Week 8

• The spasticity-related quality of life tool (SQoL-6D)

  Baseline, Week 4, Week 8

Study Arms (2)

Virtual Reality Intervention

EXPERIMENTAL

Eight weeks of two 30 minute sessions using virtual reality with the upper limb exercise games.

Other: Immersive Virtual Reality Intervention

Control Group

NO INTERVENTION

Participants will be asked to continue with their usual care independent of this study.

Interventions

Immersive Virtual Reality Intervention OTHER

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).

Virtual Reality Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• MS Society, UK: collaborator
• NHS Lanarkshire: collaborator

Study Sites (1)

Amy Webster

Glasgow, Scotland, G4 0BA, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: April 11, 2022
• Study Start: June 26, 2022
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)