Multiple SclerosisNCT05320237
Immersive Virtual Reality for Upper Limb Rehabilitation in Multiple Sclerosis
A study testing Immersive Virtual Reality Intervention in people with Multiple Sclerosis, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Immersive Virtual Reality Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jun 2022to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Immersive Virtual Reality Intervention
- Keywords
- Multiple Sclerosis, Rehabilitation, Virtual reality
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality InterventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Intervention | Experimental | Eight weeks of two 30 minute sessions using virtual reality with the upper limb exercise games. Receives: Other: Immersive Virtual Reality Intervention |
| Control Group | No intervention | Participants will be asked to continue with their usual care independent of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through the intervention period of 6 months.
Secondary outcomes (7)
Nine Hole Peg Test
Measurement of hand dexterity.
Measured: 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.
Measured: Baseline, Week 4, Week 8
Hand grip strength via Jamar dynamometer
Measurement of hand grip strength.
Measured: Baseline, Week 4, Week 8
Action Research Arm Test (ARAT)
Measurement of ability of handling objects and other general upper limb movements.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start26 Jun 2022
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- MS Society, UK, NHS Lanarkshire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320237
- Sponsor's protocol ID
- 22/VRMS/115
- Status last verified
- Sep 2023
- First submitted
- 10 Mar 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Rehabilitation Using Immersive Virtual Reality for People With Multiple Sclerosis; a Feasibility Trial
- ClinicalTrials.gov ID
- NCT05320237
- Acronym / sponsor ID
- 22/VRMS/115
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Rehabilitation, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- MS Society, UK, NHS Lanarkshire
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention | Experimental | Other: Immersive Virtual Reality InterventionEight weeks of two 30 minute sessions using virtual reality with the upper limb exercise games. |
| Control Group | No intervention | –Participants will be asked to continue with their usual care independent of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality InterventionEight 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). | Other | Virtual Reality Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
7 secondary outcomes
Nine Hole Peg Test
Time frame: Baseline, Week 4, Week 8
ABLIHAND questionnaire
Time frame: Baseline, Week 4, Week 8
Hand grip strength via Jamar dynamometer
Time frame: Baseline, Week 4, Week 8
Action Research Arm Test (ARAT)
Time frame: Baseline, Week 4, Week 8
The spasticity-related quality of life tool (SQoL-6D)
Time frame: Baseline, Week 4, Week 8
USE questionnaire
Time frame: Week 8
Semi-structured interviews
Time frame: Week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Intervention in people with Multiple Sclerosis, run by Glasgow Caledonian University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rates (time frame: First 5 months of study.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.