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Not yet recruiting NCT07423091

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

No phase Interventional Chronic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exergame-Based Upper-Limb Training, Conventional Individual Rehabilitation.
Who it may be relevant to
Registry conditions: Chronic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

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.

Interventions

  • 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
  • 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 peri

Primary outcome measures

  • Upper-Limb Functionality (Action Research Arm Test, ARAT) [Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2)]
Secondary outcome measures (4)
  • Health-Related Quality of Life (EQ-5D-5L) [Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).]
  • Upper-Limb Functional performance (Wolf Motor Function Test, WMFT) [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) [Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2).]
  • Perceived Manual Function (ABILHAND Questionnaire) [Time frame: Baseline (V0), 8 weeks (V1), and 16 weeks follow-up (V2)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07423091 · NEUROREAVIRTICTUS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗