Immersive Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis

September 11, 2023 updated by: Glasgow Caledonian University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rates
Time Frame: First 5 months of study.
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
Time Frame: Through the intervention period of 6 months.
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
Time Frame: Through the intervention period of 6 months.
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
Time Frame: Week 8 of intervention.
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.
Time Frame: Through the intervention period of 6 months.
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
Time Frame: Through the intervention period of 6 months.
Recording if participants are able to complete the upper limb related outcomes.
Through the intervention period of 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nine Hole Peg Test
Time Frame: Baseline, Week 4, Week 8
Measurement of hand dexterity.
Baseline, Week 4, Week 8
ABLIHAND questionnaire
Time Frame: Baseline, Week 4, Week 8
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
Time Frame: Baseline, Week 4, Week 8
Measurement of hand grip strength.
Baseline, Week 4, Week 8
Action Research Arm Test (ARAT)
Time Frame: Baseline, Week 4, Week 8
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)
Time Frame: Baseline, Week 4, Week 8
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
Time Frame: Week 8
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
Time Frame: Week 9
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glasgow Caledonian University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NHS Lanarkshire
MS Society, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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