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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Stroke
• Intervention / Treatment: Behavioral: Exergame-Based Upper-Limb Training; Behavioral: Conventional Individual Rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marina Castel-Sánchez, PhD; Phone Number: +34679448994; Email: marina.castel@universidadeuropea.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exergame-Based Rehabilitation; 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.	Behavioral: Exergame-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.
Active Comparator: Conventional Home-Based Rehabilitation; 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.	Behavioral: Conventional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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).
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)

Other Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: Marina Castel Sánchez

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Telerehabilitation; Chronic Stroke; Exergames; Upper Limb Rehabilitation; Serious Games
• Other Study ID Numbers: NEUROREAVIRTICTUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No