Multiple SclerosisNCT04171908
Semi-inmersive Virtual Reality on Upper Limb in Multiple Sclerosis
A study testing Conventional therapy and semi-inversive tech in people with Multiple Sclerosis and Treatment Adherence, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Video games based on VR technology are emerging as valid tools used in neurorehabilitation for patients with neurological disorders, and as a low cost and easily accepted adjunct to traditional therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Treatment Adherence, Upper Extremity Paresis
- What is being tested?
- Conventional therapy and semi-inversive tech
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 12 Nov 2019to 11 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
- Diagnosis of MS according to McDonald's criteria.
- Assessment on the Kurtzke Scale of the State of Multiple Sclerosis Disability (EDSS) with a score between 1.0 and 7.5.
- Stable medical treatment for at least six months prior to the intervention.
- Muscle tone in the upper extremities not greater than 2 points (moderate hypertonia, increased muscle tone during most of the arc of movement, but the affected part can easily be moved passively) on the modified Ashworth Scale.
- Score less than or equal to 4 points in the section ¨Piramidal Function¨ of the functional scale of the EDSS.
- Absence of cognitive impairment, with the ability to understand the instructions and obtain a score equal to or greater than 24 in the Minimental Test.
- Score equal to or less than 2 points in the section ¨Functions Mental¨ of the EDSS.
Who cannot join
- Diagnosis of another neurological disease or musculoskeletal disorder other than MS.
- Diagnosis of any cardiovascular, respiratory or metabolic disease.
- Other conditions that may interfere with this study, having suffered an exacerbation or hospitalization in the last 3 months before starting the protocol of assessment, or during the therapeutic intervention process.
- Having received a steroid cycle, intravenously or orally, 6 months before the start of the assessment protocol and within the intervention period of study duration.
- Having received treatment with botulinum toxin in the six months prior to the start of the study.
- Presence of uncorrected visual disturbances through eye devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Semi-inmersive Virtual Reality Training Program on Muscle Strength, Coordination, Fatigue, Functionality and Quality of Life in Patients With Multiple Sclerosis
Video games based on VR technology are emerging as valid tools used in neurorehabilitation for patients with neurological disorders, and as a low cost and easily accepted adjunct to traditional therapy. Standard games such as the Nintendo Wii, Playstation Move and Kinect plus XBOX 360 have been used in EM rehabilitation. However, often these are either too difficult for patients or the games progress too quickly, failing to provide impairment-focused training or specifically address patients' needs [10]. Therefore, it is necessary to develop specific serious games for EM patients. Serious games are defined as games designed for a primary purpose other than that of pure entertainment, and which promote learning and behavior changes for EM patients. In this context, gesture caption devices (such as MYO, LEAP or Joy Con´s Nintendo Switch), which uses a sensor that captures the movement of the patient's forearms and hands are really interesting in rehabilitation contexts. This generates a virtual image of the upper limbs on a computer screen and the patient is prompted to perform movements according to the functional task proposed. This system presents important advantages namely thanks to its portability, ease of use, commercial availability, low cost and non-invasive nature. However, evidence is lacking that supports the therapeutic use of semi-inmersive VR technology in the treatment of upper limb (UL) motor disorders in EM.
- Being tested
- Conventional therapy, semi-inversive tech
- Medical subject headings
- Multiple Sclerosis, Treatment Adherence and Compliance, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapyOther
Conventional Physical therapy for the upper limb
semi-inversive techOther
Conventional Physical therapy for the upper limb plus Semi-inversive tech
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Active comparator | Conventional Physical therapy for the upper limb Receives: Other: Conventional therapy |
| semi-inmersive VR technology plus conventional therapy | Experimental | Conventional Physical therapy for the upper limb plus semi-inmersive VR technology Receives: Other: semi-inversive tech |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jamar
Hand-held dynamometer: it is an instrument to measure the maximumisometric strength of the hand and forearm muscles. It consists of a sealed hydraulic system with adjustable hand spacing that measures hand grip force. The strength reading can be viewed as pounds or kilograms.Thedynamometer is used for testing the hand grip force and for tracking the grip strength improvements during rehabilitation.
Measured: 8 weeks
Box and blocks
Coordination test: to measure unilateral gross manual dexterity in both the less and more affected side. The Box and blocks consists of moving the maximum number of blocks from one compartment of a box to another, one by one, within one minute. The Box and blocks is a quick, simple, and reliable measurement of manual dexterity. Its administration procedure is standardized and its validity has been shown in elderly subjects with upper limb disability
Measured: 8 weeks
The Purdue Pegboard Test
Motricity: to assess coordination, speed of movement and fine motor dexterity. The The Purdue Pegboard Test features a board with two columns with 25 holes each and a specific number of pins, washers and collars placed in four containers across the top of the board. The test consists of inserting as many pins as possible in three distinct phases, with a time limit of 30 s for each. First, the test is performed with the less affected side, then with the more affected side, then with both hands at the same time and, finally, an assembly test is performed (60 s). The number of pins inserted is subsequently recorded.
Measured: 8 weeks
Nine Hole Peg Test
Motricity: It is a hand function test, which consists of a plastic peg board (25.0 cm × 12.7 cm × 2.3 cm) with nine holes (2.54 cm between the holes) and nine pegs (3.2 cm long, 0.64 cm wide). The participant had to put the nine pegs in the peg board as fast as possible, one at the time with one hand only, and remove them again. The test was performed two times per hand, with the non-affected hand first. The time it takes to fulfill the second trial with the more-affected hand was used for the analysis
Measured: 8 weeks
Secondary outcomes (2)
The Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire was used to evaluate the satisfaction of health service users for both groups. This is a self-administered post-treatment questionnaire, comprising eight items which evaluate the level of satisfaction regarding the care and quality of the service received and the level of fulfillment of the patient's expectations regarding the treatment administered. The total score of the questionnaire is 32 points, with higher values meaning higher satisfaction with the treatment received
Measured: after 8 weeks of treatment
Adherence
The attendance rate (%) for therapy sessions (compliance) will be registered
Measured: after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start12 Nov 2019
- Primary completion11 Mar 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171908
- Sponsor's protocol ID
- Virtual Arms-EM
- Status last verified
- Jun 2023
- First submitted
- 12 Nov 2019
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marcos-Anton S, Cano-de-la-Cuerda R, Aranda-Reneo I, Jardon-Huete A, Ona-Simbana ED, Oliva-Moreno J. Cost-effectiveness analysis of the MYO Armband(R) device in combination with specifically designed video games for upper limb rehabilitation in people with multiple sclerosis. J Neuroeng Rehabil. 2025 Nov 27;23(1):52. doi: 10.1186/s12984-025-01801-x.
PubMed 41299524Marcos-Anton S, Jardon-Huete A, Ona-Simbana ED, Blazquez-Fernandez A, Martinez-Rolando L, Cano-de-la-Cuerda R. sEMG-controlled forearm bracelet and serious game-based rehabilitation for training manual dexterity in people with multiple sclerosis: a randomised controlled trial. J Neuroeng Rehabil. 2023 Aug 19;20(1):110. doi: 10.1186/s12984-023-01233-5.
PubMed 37598176Cuesta-Gomez A, Martin-Diaz P, Sanchez-Herrera Baeza P, Martinez-Medina A, Ortiz-Comino C, Cano-de-la-Cuerda R. Nintendo Switch Joy-Cons' Infrared Motion Camera Sensor for Training Manual Dexterity in People with Multiple Sclerosis: A Randomized Controlled Trial. J Clin Med. 2022 Jun 7;11(12):3261. doi: 10.3390/jcm11123261.
PubMed 35743333Cuesta-Gomez A, Sanchez-Herrera-Baeza P, Ona-Simbana ED, Martinez-Medina A, Ortiz-Comino C, Balaguer-Bernaldo-de-Quiros C, Jardon-Huete A, Cano-de-la-Cuerda R. Effects of virtual reality associated with serious games for upper limb rehabilitation inpatients with multiple sclerosis: randomized controlled trial. J Neuroeng Rehabil. 2020 Jul 13;17(1):90. doi: 10.1186/s12984-020-00718-x.
PubMed 32660604
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Semi-inmersive Virtual Reality Training Program on Muscle Strength, Coordination, Fatigue, Functionality and Quality of Life in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04171908
- Acronym / sponsor ID
- Virtual Arms-EM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 11 Mar 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 21 Nov 2019 (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.
Video games based on VR technology are emerging as valid tools used in neurorehabilitation for patients with neurological disorders, and as a low cost and easily accepted adjunct to traditional therapy. Standard games such as the Nintendo Wii, Playstation Move and Kinect plus XBOX 360 have been used in EM rehabilitation. However, often these are either too difficult for patients or the games progress too quickly, failing to provide impairment-focused training or specifically address patients' needs [10]. Therefore, it is necessary to develop specific serious games for EM patients. Serious games are defined as games designed for a primary purpose other than that of pure entertainment, and which promote learning and behavior changes for EM patients. In this context, gesture caption devices (such as MYO, LEAP or Joy Con´s Nintendo Switch), which uses a sensor that captures the movement of the patient's forearms and hands are really interesting in rehabilitation contexts. This generates a virtual image of the upper limbs on a computer screen and the patient is prompted to perform movements according to the functional task proposed. This system presents important advantages namely thanks to its portability, ease of use, commercial availability, low cost and non-invasive nature. However, evidence is lacking that supports the therapeutic use of semi-inmersive VR technology in the treatment of upper limb (UL) motor disorders in EM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Active comparator | Other: Conventional therapyConventional Physical therapy for the upper limb |
| semi-inmersive VR technology plus conventional therapy | Experimental | Other: semi-inversive techConventional Physical therapy for the upper limb plus semi-inmersive VR technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of MS according to McDonald's criteria.
- Assessment on the Kurtzke Scale of the State of Multiple Sclerosis Disability (EDSS) with a score between 1.0 and 7.5.
- Stable medical treatment for at least six months prior to the intervention.
- Muscle tone in the upper extremities not greater than 2 points (moderate hypertonia, increased muscle tone during most of the arc of movement, but the affected part can easily be moved passively) on the modified Ashworth Scale.
- Score less than or equal to 4 points in the section ¨Piramidal Function¨ of the functional scale of the EDSS.
Key exclusion criteria (6 listed)
- Diagnosis of another neurological disease or musculoskeletal disorder other than MS.
- Diagnosis of any cardiovascular, respiratory or metabolic disease.
- Other conditions that may interfere with this study, having suffered an exacerbation or hospitalization in the last 3 months before starting the protocol of assessment, or during the therapeutic intervention process.
- Having received a steroid cycle, intravenously or orally, 6 months before the start of the assessment protocol and within the intervention period of study duration.
- Having received treatment with botulinum toxin in the six months prior to the start of the study.
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 |
|---|---|---|
| Conventional therapyConventional Physical therapy for the upper limb | Other | Conventional therapy |
| semi-inversive techConventional Physical therapy for the upper limb plus Semi-inversive tech | Other | semi-inmersive VR technology plus conventional therapy |
Primary outcome
Jamar
Time frame: 8 weeks
Hand-held dynamometer: it is an instrument to measure the maximumisometric strength of the hand and forearm muscles. It consists of a sealed hydraulic system with adjustable hand spacing that measures hand grip force. The strength reading can be viewed as pounds or kilograms.Thedynamometer is used for testing the hand grip force and for tracking the grip strength improvements during rehabilitation.
Box and blocks
Time frame: 8 weeks
Coordination test: to measure unilateral gross manual dexterity in both the less and more affected side. The Box and blocks consists of moving the maximum number of blocks from one compartment of a box to another, one by one, within one minute. The Box and blocks is a quick, simple, and reliable measurement of manual dexterity. Its administration procedure is standardized and its validity has been shown in elderly subjects with upper limb disability
The Purdue Pegboard Test
Time frame: 8 weeks
Motricity: to assess coordination, speed of movement and fine motor dexterity. The The Purdue Pegboard Test features a board with two columns with 25 holes each and a specific number of pins, washers and collars placed in four containers across the top of the board. The test consists of inserting as many pins as possible in three distinct phases, with a time limit of 30 s for each. First, the test is performed with the less affected side, then with the more affected side, then with both hands at the same time and, finally, an assembly test is performed (60 s). The number of pins inserted is subsequently recorded.
Nine Hole Peg Test
Time frame: 8 weeks
Motricity: It is a hand function test, which consists of a plastic peg board (25.0 cm × 12.7 cm × 2.3 cm) with nine holes (2.54 cm between the holes) and nine pegs (3.2 cm long, 0.64 cm wide). The participant had to put the nine pegs in the peg board as fast as possible, one at the time with one hand only, and remove them again. The test was performed two times per hand, with the non-affected hand first. The time it takes to fulfill the second trial with the more-affected hand was used for the analysis
2 secondary outcomes
The Client Satisfaction Questionnaire
Time frame: after 8 weeks of treatment
Adherence
Time frame: after 8 weeks of treatment
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 23 Jun 2023.
- Derived from this study: PubMed 41299524Marcos-Anton S, Cano-de-la-Cuerda R, Aranda-Reneo I, Jardon-Huete A, Ona-Simbana ED, Oliva-Moreno J. Cost-effectiveness analysis of the MYO Armband(R) device in combination with specifically designed video games for upper limb rehabilitation in people with multiple sclerosis. J Neuroeng Rehabil. 2025 Nov 27;23(1):52. doi: 10.1186/s12984-025-01801-x.
- Derived from this study: PubMed 37598176Marcos-Anton S, Jardon-Huete A, Ona-Simbana ED, Blazquez-Fernandez A, Martinez-Rolando L, Cano-de-la-Cuerda R. sEMG-controlled forearm bracelet and serious game-based rehabilitation for training manual dexterity in people with multiple sclerosis: a randomised controlled trial. J Neuroeng Rehabil. 2023 Aug 19;20(1):110. doi: 10.1186/s12984-023-01233-5.
- Derived from this study: PubMed 35743333Cuesta-Gomez A, Martin-Diaz P, Sanchez-Herrera Baeza P, Martinez-Medina A, Ortiz-Comino C, Cano-de-la-Cuerda R. Nintendo Switch Joy-Cons' Infrared Motion Camera Sensor for Training Manual Dexterity in People with Multiple Sclerosis: A Randomized Controlled Trial. J Clin Med. 2022 Jun 7;11(12):3261. doi: 10.3390/jcm11123261.
- Derived from this study: PubMed 32660604Cuesta-Gomez A, Sanchez-Herrera-Baeza P, Ona-Simbana ED, Martinez-Medina A, Ortiz-Comino C, Balaguer-Bernaldo-de-Quiros C, Jardon-Huete A, Cano-de-la-Cuerda R. Effects of virtual reality associated with serious games for upper limb rehabilitation inpatients with multiple sclerosis: randomized controlled trial. J Neuroeng Rehabil. 2020 Jul 13;17(1):90. doi: 10.1186/s12984-020-00718-x.
- Individual participant dataSharing planned: No
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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 Conventional therapy and semi-inversive tech in people with Multiple Sclerosis and Treatment Adherence, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 7 inclusion and 6 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 23 Jun 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 Spain. 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?
Jamar (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171908, which also lists 4 linked publications.
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 23 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.