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

NCT07423091 | Not Yet Recruiting

• 1 other identifier: NEUROREAVIRTICTUS
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Stroke

Keywords

Chronic Stroke; Upper Limb Rehabilitation; Exergames; Serious Games; Telerehabilitation

Outcome Measures

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.

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

Secondary Outcomes (4)

• Health-Related Quality of Life (EQ-5D-5L)

  Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).

• Upper-Limb Functional performance (Wolf Motor Function Test, WMFT)

  Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).

• Upper-Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE)

  Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).

• Perceived Manual Function (ABILHAND Questionnaire)

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

Other Outcomes (10)

• Adherence to the Program

  During the 8-week intervention period

• Effective Practice Dosage

  During the 8-week intervention period.

• Movement Accuracy

  During each training session across the 8-week intervention period.

Study Arms (2)

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.

Behavioral: Exergame-Based Upper-Limb Training

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.

Behavioral: Conventional Individual Rehabilitation

Interventions

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.

Exergame-Based Rehabilitation

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.

Conventional Home-Based Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marina Castel Sánchez: lead

Central Study Contacts

Marina Castel-Sánchez, PhD

CONTACT

+34679448994; marina.castel@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will remain blinded to group assignment throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02