Exergame-Based Upper-Limb Rehabilitation in Adults With Chronic Stroke

N/ANot Yet RecruitingNCT07423091

Marina Castel Sánchez32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Stroke

Interventions

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 RehabilitationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2)

Secondary Outcomes

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.

Time frame: 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.

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)

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.

Time frame: 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.

Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2)

Exergame-Based Upper-Limb Rehabilitation in Adults With Chronic Stroke

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts