Multiple SclerosisNCT07430462
Home-Based Exergame Rehabilitation for Upper Limb Function in People With Multiple Sclerosis
A study testing Exergame-Based Upper Limb Rehabilitation Program and Conventional Home-Based Physiotherapy in people with Multiple Sclerosis, run by Marina Castel Sánchez at 1 site in Spain.
Trial summary
This randomized pilot clinical trial aims to evaluate the effectiveness, feasibility, and cost-effectiveness of a semi-autonomous upper-limb rehabilitation program based on therapeutic exergames in people with Multiple Sclerosis (MS). 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?
- Exergame-Based Upper Limb Rehabilitation Program and Conventional Home-Based Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years.
- Clinical diagnosis of Multiple Sclerosis with EDSS score between 2.0 and 6.5, with upper-limb involvement.
- Ability to maintain independent sitting and to stand with or without assistive devices.
- Upper-limb functional capacity between 11 and 54 points on the ARAT, indicating limited to substantial impairment.
- Cognitive ability to understand and follow simple instructions, demonstrated by a Mini-Mental State Examination score ≥ 23.
- Provision of written informed consent by the participant or legally authorized representative.
Who cannot join
- Acute illness, musculoskeletal injury, or pain interfering with the ability to perform the intervention exercises.
- Uncompensated visual or hearing impairments that limit participation.
- Disruptive behavior or other conditions that significantly hinder participation in the rehabilitation program.
- Active epilepsy or any medical contraindication to physical exercise.
- Botulinum toxin treatment in the upper limb within the previous 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universidad Europea de Madrid
Villaviciosa de Odón, Madrid, 28670
Marina Castel-Sánchez, PhD, marina.castel@universidadeuropea.es
About this study
Official title: Effectiveness and Feasibility of a Home-Based Exergame Rehabilitation Protocol for Upper Limb Function in Individuals With Multiple Sclerosis: A Randomized Controlled Pilot Trial
This randomized pilot clinical trial aims to evaluate the effectiveness, feasibility, and cost-effectiveness of a semi-autonomous upper-limb rehabilitation program based on therapeutic exergames in people with Multiple Sclerosis (MS). The intervention integrates intensive motor practice, multisensory feedback, and cognitively demanding tasks to enhance upper-limb function, dexterity, and patient autonomy. Participants will be randomly assigned to either an exergame-based home rehabilitation program with remote physiotherapist supervision or a dose-matched conventional home-based physiotherapy program.
The primary outcome is upper-limb functionality measured by the Action Research Arm Test (ARAT). Secondary outcomes include motor function, manual ability, quality of life, usability, adherence, and digital performance metrics related to the execution of motor and cognitive tasks. Follow-up at 16 weeks will assess the sustainability of treatment effects.
This study seeks to generate evidence on whether exergame-based rehabilitation can serve as an accessible, scalable, and patient-centered alternative to conventional home-based upper-limb rehabilitation for individuals with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Exergame-Based Upper Limb Rehabilitation Program, Conventional Home-Based Physiotherapy
- Keywords
- Multiple Sclerosis, Upper Limb Rehabilitation, Exergames, Home-Based Rehabilitation, Virtual Reality Rehablitation, Cost-effectiveness, Usability
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame-Based Upper Limb Rehabilitation ProgramBehavioural
Participants in the experimental group will complete a semi-autonomous home-based exergame rehabilitation program targeting upper-limb motor, sensory, and perceptual function. The intervention integrates intensive motor practice, multisensory feedback, dual-task demands, visuomotor coordination, and progressive task difficulty. Remote supervision will be provided by a physiotherapist to monitor adherence, adjust progression, and ensure safety.
Dose and Schedule:
5 sessions per week 30-40 minutes per session Duration: 8 weeks
Mode of Delivery:
Home-based training using therapeutic exergames, with remote monitoring and session review by a physiotherapist.
Conventional Home-Based PhysiotherapyBehavioural
Participants in the control group will follow a conventional individualized physiotherapy program focused on upper-limb motor rehabilitation. The program includes strengthening exercises, functional upper-limb tasks, and repetitive practice designed to match the dose and duration of the experimental group.
Dose and Schedule:
5 sessions per week 30-40 minutes per session Duration: 8 weeks
Mode of Delivery:
Home-based exercises with standard clinical follow-up and therapist support as needed.
| Study group | Role | What they receive |
|---|---|---|
| Exergame-Based Semi-Autonomous Program | Experimental | Participants will complete a semi-autonomous home-based exergame rehabilitation program targeting upper-limb motor and sensory function. The program integrates multisensory feedback, motor sequencing, coordination, and dual-task demands. Remote supervision will be provided by a physiotherapist.
Dose: 30-40 minutes per session, 5 sessions/week for 8 weeks
Mode of Delivery: Home-based with remote monitoring Receives: Behavioral: Exergame-Based Upper Limb Rehabilitation Program |
| Conventional Physiotherapy Program | Active comparator | Participants will complete an individualized home-based physiotherapy program including strengthening exercises and functional upper-limb tasks, matched in duration and frequency to the experimental arm.
Dose: 30-40 minutes per session, 5 sessions/week for 8 weeks
Mode of Delivery: Home exercise program with standard follow-up Receives: Behavioral: Conventional Home-Based Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
The ARAT assesses upper-limb functionality across four domains: grasp, grip, pinch, and gross movement. Scores range from 0 to 57, with higher scores indicating better upper-limb function and less impairment.
Measured: Baseline (V0), Week 8 (V1), Week 16 (V2)
Secondary outcomes (5)
EuroQol EQ-5D-5L
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) is a standardized measure of health-related quality of life. It provides (1) a utility index score, ranging from -0.281 to 1.000, where higher scores indicate better health status, and (2) a Visual Analog Scale (VAS) ranging from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health.
Measured: Baseline, Week 8, Week 16
Wolf Motor Function Test (WMFT)
Assesses upper-limb motor performance through timed tasks and strength measures. Scores range from 0 to 75, with higher scores indicating better motor function.
Measured: Baseline, Week 8, Week 16
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Evaluates motor function, sensation, passive joint mobility, and joint pain. Total scores range from 0 to 66, with higher scores indicating better motor recovery.
Measured: Baseline, Week 8, Week 16
ABILHAND Questionnaire
The ABILHAND Questionnaire is a patient-reported measure of perceived manual ability during bimanual activities of daily living. Each item is rated using three response categories: "impossible," "difficult," and "easy." Responses are converted through Rasch analysis into a linear measure of manual ability. The official scoring system provides Rasch-transformed results that can be expressed on a 0-100 scale, where 0 represents the lowest manual ability and 100 represents the highest manual ability.Higher scores indicate better perceived manual ability.
Measured: Baseline, Week 8, Week 16
Postural Compensations
Postural control will be evaluated as the number of compensatory postural movements detected by the digital platform during each training session. Higher values indicate poorer postural control.
Measured: During each training session across the 8-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marina Castel Sánchez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marina Castel Sánchez, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430462
- Sponsor's protocol ID
- NEUROREAVIRTEM
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Feasibility of a Home-Based Exergame Rehabilitation Protocol for Upper Limb Function in Individuals With Multiple Sclerosis: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07430462
- Acronym / sponsor ID
- NEUROREAVIRTEM
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Upper Limb Rehabilitation, Exergames, Home-Based Rehabilitation, Virtual Reality Rehablitation, Cost-effectiveness, Usability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marina Castel SánchezUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (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.
This randomized pilot clinical trial aims to evaluate the effectiveness, feasibility, and cost-effectiveness of a semi-autonomous upper-limb rehabilitation program based on therapeutic exergames in people with Multiple Sclerosis (MS). The intervention integrates intensive motor practice, multisensory feedback, and cognitively demanding tasks to enhance upper-limb function, dexterity, and patient autonomy. Participants will be randomly assigned to either an exergame-based home rehabilitation program with remote physiotherapist supervision or a dose-matched conventional home-based physiotherapy program.
The primary outcome is upper-limb functionality measured by the Action Research Arm Test (ARAT). Secondary outcomes include motor function, manual ability, quality of life, usability, adherence, and digital performance metrics related to the execution of motor and cognitive tasks. Follow-up at 16 weeks will assess the sustainability of treatment effects.
This study seeks to generate evidence on whether exergame-based rehabilitation can serve as an accessible, scalable, and patient-centered alternative to conventional home-based upper-limb rehabilitation for individuals with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergame-Based Semi-Autonomous Program | Experimental | Behavioral: Exergame-Based Upper Limb Rehabilitation ProgramParticipants will complete a semi-autonomous home-based exergame rehabilitation program targeting upper-limb motor and sensory function. The program integrates multisensory feedback, motor sequencing, coordination, and dual-task demands. Remote supervision will be provided by a physiotherapist. Dose: 30-40 minutes per session, 5 sessions/week for 8 weeks Mode of Delivery: Home-based with remote monitoring |
| Conventional Physiotherapy Program | Active comparator | Behavioral: Conventional Home-Based PhysiotherapyParticipants will complete an individualized home-based physiotherapy program including strengthening exercises and functional upper-limb tasks, matched in duration and frequency to the experimental arm. Dose: 30-40 minutes per session, 5 sessions/week for 8 weeks Mode of Delivery: Home exercise program with standard follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Clinical diagnosis of Multiple Sclerosis with EDSS score between 2.0 and 6.5, with upper-limb involvement.
- Ability to maintain independent sitting and to stand with or without assistive devices.
- Upper-limb functional capacity between 11 and 54 points on the ARAT, indicating limited to substantial impairment.
- Cognitive ability to understand and follow simple instructions, demonstrated by a Mini-Mental State Examination score ≥ 23.
Key exclusion criteria (5 listed)
- Acute illness, musculoskeletal injury, or pain interfering with the ability to perform the intervention exercises.
- Uncompensated visual or hearing impairments that limit participation.
- Disruptive behavior or other conditions that significantly hinder participation in the rehabilitation program.
- Active epilepsy or any medical contraindication to physical exercise.
- Botulinum toxin treatment in the upper limb within the previous 6 months.
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 |
|---|---|---|
| Exergame-Based Upper Limb Rehabilitation ProgramParticipants in the experimental group will complete a semi-autonomous home-based exergame rehabilitation program targeting upper-limb motor, sensory, and perceptual function. The intervention integrates intensive motor practice, multisensory feedback, dual-task demands, visuomotor coordination, and progressive task difficulty. Remote supervision will be provided by a physiotherapist to monitor adherence, adjust progression, and ensure safety. Dose and Schedule: 5 sessions per week 30-40 minutes per session Duration: 8 weeks Mode of Delivery: Home-based training using therapeutic exergames, with remote monitoring and session review by a physiotherapist. | Behavioural | Exergame-Based Semi-Autonomous Program |
| Conventional Home-Based PhysiotherapyParticipants in the control group will follow a conventional individualized physiotherapy program focused on upper-limb motor rehabilitation. The program includes strengthening exercises, functional upper-limb tasks, and repetitive practice designed to match the dose and duration of the experimental group. Dose and Schedule: 5 sessions per week 30-40 minutes per session Duration: 8 weeks Mode of Delivery: Home-based exercises with standard clinical follow-up and therapist support as needed. | Behavioural | Conventional Physiotherapy Program |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
The ARAT assesses upper-limb functionality across four domains: grasp, grip, pinch, and gross movement. Scores range from 0 to 57, with higher scores indicating better upper-limb function and less impairment.
5 secondary outcomes
EuroQol EQ-5D-5L
Time frame: Baseline, Week 8, Week 16
Wolf Motor Function Test (WMFT)
Time frame: Baseline, Week 8, Week 16
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: Baseline, Week 8, Week 16
ABILHAND Questionnaire
Time frame: Baseline, Week 8, Week 16
Postural Compensations
Time frame: During each training session across the 8-week intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame-Based Upper Limb Rehabilitation Program and Conventional Home-Based Physiotherapy in people with Multiple Sclerosis, run by Marina Castel Sánchez 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 24 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)). 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 24 Feb 2026.