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NCT Number: NCT07423091

Exergame-Based Upper-Limb Rehabilitation in Adults 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Upper-Limb Functionality (Action Research Arm Test, ARAT)

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Perceived Manual Function (ABILHAND Questionnaire)

    Time frame: 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.

Other outcomes

  1. Adherence to the Program

    Time frame: During the 8-week intervention period

    Percentage of completed sessions out of the total prescribed 40 sessions. Adherence will be considered adequate when ≥80% of sessions are completed.

  2. Effective Practice Dosage

    Time frame: During the 8-week intervention period.

    Total time (minutes) of active execution of motor or cognitive tasks during sessions, recorded directly by the physiotherapist using manual timing.

  3. Movement Accuracy

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

    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.

  4. Perceived Effort Intensity

    Time frame: Assessed at the end of each session during the 8-week intervention period.

    Perceived exertion will be measured at the end of each session using the Modified Borg Scale (0-10). Higher scores indicate greater perceived effort.

  5. Professional Workload

    Time frame: During the 8-week intervention period.

    Total time (minutes) spent by the physiotherapist preparing, supervising, and documenting each session.

  6. Usability (System Usability Scale)

    Time frame: Assessed at the end of the 8-week intervention (V1)

    Usability will be assessed using the System Usability Scale (SUS; score 0-100). Higher scores indicate better usability.

  7. Efficiency

    Time frame: During the full study period up to follow-up at 16 weeks (V2).

    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.

  8. Postural Compensations

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

    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.

  9. Patient Satisfaction (5-point Likert Scale)

    Time frame: Week 8

    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.

  10. Social Value

    Time frame: During the full study period up to follow-up at 16 weeks (V2).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marina Castel-Sánchez, PhD

CONTACT

[email protected]

+34679448994

Sponsors and collaborators

Lead sponsor

Marina Castel Sánchez

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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