Exergame-Based Upper-Limb Rehabilitation in Adults With 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 →
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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