Chronic Stroke
Conditions
Keywords
Chronic Stroke, Upper Limb Rehabilitation, Exergames, Serious Games, Telerehabilitation
Brief 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. 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.
Interventions
BEHAVIORALExergame-Based Upper-Limb Training
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.
BEHAVIORALConventional Individual Rehabilitation
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.
Sponsors
Marina Castel Sánchez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will remain blinded to group assignment throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper-Limb Functionality (Action Research Arm Test, ARAT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper-Limb Functional performance (Wolf Motor Function Test, WMFT) | Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2). | 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. |
| Health-Related Quality of Life (EQ-5D-5L) | Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2). | 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. |
| Upper-Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE) | Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2). | 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. |
| Perceived Manual Function (ABILHAND Questionnaire) | Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2) | 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. |
Contacts
CONTACTMarina Castel-Sánchez, PhD
Outcome results
None listed