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

CompletedNot a drug-phase studyMS (type not specified)NCT05320237

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Immersive Virtual Reality Intervention

What it measured

Main measures

  • Recruitment Rates

    First 5 months of study.

    Feasibility
  • Number of intervention sessions completed by participants

    Through the intervention period of 6 months.

  • Recording the number of drop out rates from participants

    Through the intervention period of 6 months.

  • Acceptance of being assigned to the control arm

    Week 8 of intervention.

  • Reporting adverse effects from intervention.

    Through the intervention period of 6 months.

    Safety
  • Rate of completion of secondary outcomes

    Through the intervention period of 6 months.

    Arm and hand function

Other measures (7)

  • Nine Hole Peg Test

    Baseline, Week 4, Week 8

    Arm and hand function
  • ABLIHAND questionnaire

    Baseline, Week 4, Week 8

    Arm and hand function
  • Hand grip strength via Jamar dynamometer

    Baseline, Week 4, Week 8

    Arm and hand functionPhysical function
  • Action Research Arm Test (ARAT)

    Baseline, Week 4, Week 8

    Arm and hand function
  • The spasticity-related quality of life tool (SQoL-6D)

    Baseline, Week 4, Week 8

    Arm and hand functionSpasticityQuality of life (reported by participants)
  • USE questionnaire

    Week 8

    Quality of life (reported by participants)
  • Semi-structured interviews

    Week 9

Who could take part

MS (type not specified) · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jun 2022

    2. Main results due

      Apr 2023

    3. Finished

      Apr 2023

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