Exergame-Based Upper-Limb Rehabilitation in Adults With Chronic Stroke
ConditionChronic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarina Castel Sánchez
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Exergame-Based Upper-Limb Training
BehavioralParticipants 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 Rehabilitation
BehavioralParticipants 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Exergame-Based RehabilitationExperimental treatment 1 intervention
Group B: Conventional Home-Based RehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
1
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).2
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).3
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).4
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)Other outcomes
1
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.
Time frame
During the 8-week intervention period2
Effective Practice Dosage
Total time (minutes) of active execution of motor or cognitive tasks during sessions, recorded directly by the physiotherapist using manual timing.
Time frame
During the 8-week intervention period.3
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.
Time frame
During each training session across the 8-week intervention period.4
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.
Time frame
Assessed at the end of each session during the 8-week intervention period.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Marina Castel Sánchez
Lead sponsor
European University of Madrid
Sponsor institution
Source ClinicalTrials.gov
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