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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exergame-Based Upper-Limb Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2). |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the Program | Percentage of completed sessions out of the total prescribed 40 sessions. Adherence will be considered adequate when ≥80% of sessions are completed. | During the 8-week intervention period |
| Effective Practice Dosage |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marina Castel-Sánchez, PhD | Contact | +34679448994 | marina.castel@universidadeuropea.es |
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Outcome assessors will remain blinded to group assignment throughout the study.
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| Conventional Individual Rehabilitation | Behavioral | 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. |
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| 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. |
| 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. | 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. | Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2) |
Total time (minutes) of active execution of motor or cognitive tasks during sessions, recorded directly by the physiotherapist using manual timing.
| During the 8-week intervention period. |
| Movement Accuracy | Movement accuracy will be quantified as the number of correctly performed task executions recorded by the digital platform during each training session. Higher values indicate better task performance and motor control. | During each training session across the 8-week intervention period. |
| Perceived Effort Intensity | Perceived exertion will be measured at the end of each session using the Modified Borg Scale (0-10). Higher scores indicate greater perceived effort. | Assessed at the end of each session during the 8-week intervention period. |
| Professional Workload | Total time (minutes) spent by the physiotherapist preparing, supervising, and documenting each session. | During the 8-week intervention period. |
| Usability (System Usability Scale) | Usability will be assessed using the System Usability Scale (SUS; score 0-100). Higher scores indicate better usability. | Assessed at the end of the 8-week intervention (V1) |
| Efficiency | Efficiency will be assessed by calculating cost-effectiveness ratios, expressed as cost per unit of clinical improvement. Direct participant-level costs (including professional time, material resources, and technical support) will be related to improvements in functional autonomy and quality of life, as measured by validated clinical outcomes such as EQ-5D-5L and ABILHAND-CS. Lower cost per unit of improvement indicates greater efficiency of the intervention. | During the full study period up to follow-up at 16 weeks (V2). |
| 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. | During each training session across the 8-week intervention period. |
| Patient Satisfaction (5-point Likert Scale) | Patient satisfaction will be assessed using a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction with the intervention. The variable will be analyzed as an ordinal outcome. | Week 8 |
| Social Value | Social value will be evaluated through the estimation of avoided healthcare costs attributable to the intervention. This will include reductions in expected healthcare resource use (e.g., unplanned visits, additional rehabilitation, or medical consultations). Higher estimated avoided costs indicate greater social value generated by the program. | During the full study period up to follow-up at 16 weeks (V2). |