Chronic StrokeNCT07423091
Exergame-Based Upper-Limb Rehabilitation in Adults With Chronic Stroke
A study testing Exergame-Based Upper-Limb Training and Conventional Individual Rehabilitation in people with Chronic Stroke, run by Marina Castel Sánchez.
Trial summary
This study is a randomized controlled trial designed to evaluate the effectiveness of a semi-autonomous upper-limb rehabilitation program based on exergames in adults with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Exergame-Based Upper-Limb Training and Conventional Individual Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- 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
- Adults aged 18 years or older.
- Confirmed diagnosis of chronic stroke with more than 6 months of evolution.
- Ability to maintain independent sitting and standing (with or without assistive devices).
- Upper-limb functional capacity ranging from limited to moderate, defined as an ARAT score between 11 and 54 points.
- Ability to understand and follow simple instructions (Mini-Mental State Examination ≥ 23).
- Ability to provide informed consent personally or through a legal representative.
Who cannot join
- Acute illness, musculoskeletal pathology, or pain that interferes with the performance of rehabilitation exercises.
- Uncompensated sensory deficits, including significant visual or hearing impairments.
- Disruptive behavior or neuropsychiatric conditions that may limit participation.
- Active epilepsy or any medical contraindication to physical exercise.
- Botulinum toxin treatment affecting the upper limb within the previous 6 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial Assessing the Efficacy, Feasibility, and Usability of an Exergame-Based Semi-Autonomous Upper-Limb Rehabilitation Program in Individuals With Chronic Stroke
This study is a randomized controlled trial designed to evaluate the effectiveness of a semi-autonomous upper-limb rehabilitation program based on exergames in adults with chronic stroke. Participants will be randomly assigned (1:1) to either an exergame-based intervention or an individually delivered conventional home-based therapy program. The primary outcome is upper-limb functionality as measured by the Action Research Arm Test (ARAT). Secondary outcomes include upper-limb motor function and quality of life. The study also examines adherence, usability, and the feasibility of remote monitoring for long-term implementation.
- Conditions
- Chronic Stroke
- Being tested
- Exergame-Based Upper-Limb Training, Conventional Individual Rehabilitation
- Keywords
- Chronic Stroke, Upper Limb Rehabilitation, Exergames, Serious Games, Telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame-Based Upper-Limb TrainingBehavioural
Participants will perform an individualized exergame-based rehabilitation protocol designed to provide intensive, repetitive, and task-specific upper-limb training. The program integrates multisensory feedback, progressive difficulty adjustment, and monitoring of digital performance indicators (e.g., adherence, task completion, motor accuracy).
Dosage: Participants will complete the intervention 5 times per week over an 8-week period. Each session will last approximately 30-40 minutes.
Outcome assessments at baseline(V0), week 8 (V1), and week 16 (V2) to examine maintenance of benefits.
Conventional Individual RehabilitationBehavioural
Participants assigned to the control group will receive an individualized conventional upper-limb rehabilitation program delivered through standard therapeutic exercises equivalent in therapeutic goals to the exergame protocol. Exercises target upper-limb motor function, coordination, and performance of functional tasks. This intervention does not include exergames, digital monitoring, or gamified feedback.
Dosage: Participants will complete the intervention 5 times per week over an 8-week period. Each session will last approximately 30-40 minutes.
Outcome assessments at baseline(V0), week 8 (V1), and week 16 (V2) to examine maintenance of benefits.
| Study group | Role | What they receive |
|---|---|---|
| Exergame-Based Rehabilitation | Experimental | Participants assigned to the experimental group will complete a semi-autonomous upper-limb rehabilitation program based on exergames. The intervention includes task-oriented, progressive training targeting upper-limb motor function, visuomotor coordination, and cognitive engagement (e.g., attention, decision-making). Difficulty is adjusted individually based on performance, and sessions are remotely monitored by clinicians. Receives: Behavioral: Exergame-Based Upper-Limb Training |
| Conventional Home-Based Rehabilitation | Active comparator | Participants in the control group will receive an individualized home-based upper-limb rehabilitation program delivered through conventional therapeutic exercises equivalent in duration and content focus (motor control, coordination, precision). The intervention is prescribed by a therapist and supervised periodically, without digital gaming components. Receives: Behavioral: Conventional Individual Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper-Limb Functionality (Action Research Arm Test, ARAT)
The ARAT assesses upper-limb functionality through 19 tasks categorized into grasp, grip, pinch, and gross movement. It provides a standardized, performance-based measure of upper-limb motor ability in individuals with stroke.
Measured: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2)
Secondary outcomes (4)
Health-Related Quality of Life (EQ-5D-5L)
Health-related quality of life will be assessed using the EuroQol EQ-5D-5L questionnaire, which provides both a utility index score and a Visual Analogue Scale (VAS; 0-100). Higher VAS scores indicate better perceived health status.
Measured: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).
Upper-Limb Functional performance (Wolf Motor Function Test, WMFT)
Upper-limb functional performance will be evaluated using the Wolf Motor Function Test (WMFT), which measures motor ability through timed functional tasks, strength-based assessments, and quality-of-movement ratings. Scores range from 0 to 75, with higher scores indicating better motor performance and less impairment.
Measured: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).
Upper-Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE)
Upper-limb motor recovery will be assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), which evaluates motor function, sensation, passive joint range of motion, and joint pain in individuals after stroke. Scores range from 0 to 66, with higher scores reflecting better motor function.
Measured: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).
Perceived Manual Function (ABILHAND Questionnaire)
Perceived manual ability will be measured using the ABILHAND questionnaire, which evaluates the self-reported ease or difficulty of performing bimanual activities of daily living. Responses follow an ordinal scale (impossible, difficult, easy), with higher scores indicating greater perceived manual ability.
Outcome Type: Ordinal qualitative variable.
Measured: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionOct 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 Chronic StrokeStudies 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
- 32 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
- NCT07423091
- Sponsor's protocol ID
- NEUROREAVIRTICTUS
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 20 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Assessing the Efficacy, Feasibility, and Usability of an Exergame-Based Semi-Autonomous Upper-Limb Rehabilitation Program in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT07423091
- Acronym / sponsor ID
- NEUROREAVIRTICTUS
- Conditions
- Chronic Stroke
- Keywords
- Chronic Stroke, Upper Limb Rehabilitation, Exergames, Serious Games, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Marina Castel SánchezUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 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 study is a randomized controlled trial designed to evaluate the effectiveness of a semi-autonomous upper-limb rehabilitation program based on exergames in adults with chronic stroke. Participants will be randomly assigned (1:1) to either an exergame-based intervention or an individually delivered conventional home-based therapy program. The primary outcome is upper-limb functionality as measured by the Action Research Arm Test (ARAT). Secondary outcomes include upper-limb motor function and quality of life. The study also examines adherence, usability, and the feasibility of remote monitoring for long-term implementation.
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 Rehabilitation | Experimental | Behavioral: Exergame-Based Upper-Limb TrainingParticipants assigned to the experimental group will complete a semi-autonomous upper-limb rehabilitation program based on exergames. The intervention includes task-oriented, progressive training targeting upper-limb motor function, visuomotor coordination, and cognitive engagement (e.g., attention, decision-making). Difficulty is adjusted individually based on performance, and sessions are remotely monitored by clinicians. |
| Conventional Home-Based Rehabilitation | Active comparator | Behavioral: Conventional Individual RehabilitationParticipants in the control group will receive an individualized home-based upper-limb rehabilitation program delivered through conventional therapeutic exercises equivalent in duration and content focus (motor control, coordination, precision). The intervention is prescribed by a therapist and supervised periodically, without digital gaming components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Confirmed diagnosis of chronic stroke with more than 6 months of evolution.
- Ability to maintain independent sitting and standing (with or without assistive devices).
- Upper-limb functional capacity ranging from limited to moderate, defined as an ARAT score between 11 and 54 points.
- Ability to understand and follow simple instructions (Mini-Mental State Examination ≥ 23).
Key exclusion criteria (5 listed)
- Acute illness, musculoskeletal pathology, or pain that interferes with the performance of rehabilitation exercises.
- Uncompensated sensory deficits, including significant visual or hearing impairments.
- Disruptive behavior or neuropsychiatric conditions that may limit participation.
- Active epilepsy or any medical contraindication to physical exercise.
- Botulinum toxin treatment affecting 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 TrainingParticipants will perform an individualized exergame-based rehabilitation protocol designed to provide intensive, repetitive, and task-specific upper-limb training. The program integrates multisensory feedback, progressive difficulty adjustment, and monitoring of digital performance indicators (e.g., adherence, task completion, motor accuracy). Dosage: Participants will complete the intervention 5 times per week over an 8-week period. Each session will last approximately 30-40 minutes. Outcome assessments at baseline(V0), week 8 (V1), and week 16 (V2) to examine maintenance of benefits. | Behavioural | Exergame-Based Rehabilitation |
| Conventional Individual RehabilitationParticipants assigned to the control group will receive an individualized conventional upper-limb rehabilitation program delivered through standard therapeutic exercises equivalent in therapeutic goals to the exergame protocol. Exercises target upper-limb motor function, coordination, and performance of functional tasks. This intervention does not include exergames, digital monitoring, or gamified feedback. Dosage: Participants will complete the intervention 5 times per week over an 8-week period. Each session will last approximately 30-40 minutes. Outcome assessments at baseline(V0), week 8 (V1), and week 16 (V2) to examine maintenance of benefits. | Behavioural | Conventional Home-Based Rehabilitation |
Primary outcome
Upper-Limb Functionality (Action Research Arm Test, ARAT)
Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2)
The ARAT assesses upper-limb functionality through 19 tasks categorized into grasp, grip, pinch, and gross movement. It provides a standardized, performance-based measure of upper-limb motor ability in individuals with stroke.
4 secondary outcomes
Health-Related Quality of Life (EQ-5D-5L)
Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).
Upper-Limb Functional performance (Wolf Motor Function Test, WMFT)
Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).
Upper-Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE)
Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).
Perceived Manual Function (ABILHAND Questionnaire)
Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2)
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 20 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.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame-Based Upper-Limb Training and Conventional Individual Rehabilitation in people with Chronic Stroke, run by Marina Castel Sánchez.
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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Marina Castel-Sánchez, PhD (+34679448994, marina.castel@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper-Limb Functionality (Action Research Arm Test, ARAT) (time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (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 20 Feb 2026.