Promoting Psychophysical Well-being in Children and Adolescents With Visual Impairment

Официальное название

Promoting the Psychophysical Well-Being of Children and Adolescents With Visual Impairment

Обзор

Visual impairment (VI) has significant implications not only for visual functioning, but also for the motor development, psychological well-being, and social participation of children and adolescents. Despite the fundamental role of physical activity in promoting health, autonomy, and quality of life, young people with VI still participate to a limited extent in structured physical activity programmes, owing to the lack of adapted interventions supported by robust scientific evidence. The European VIPPSTAR project (Horizon Europe 2024), conducted at the University of Trento, aims to address this gap through the development and validation of an integrated system of educational and rehabilitation interventions designed to promote the motor, physiological, and psychosocial competences of children and adolescents with VI. This study marks the transition from the validation of the exercise battery in a controlled setting, carried out during the first phase of the VIPPSTAR project, to its implementation in participants' everyday environments. The aim is to assess its effectiveness, sustainability, and impact on psychophysical and relational well-being. The study has a longitudinal, non-profit experimental design and will involve 20 children and adolescents with VI aged 10-17 years (50% female and 50% male), recruited through lower- and upper-secondary schools in the Autonomous Province of Trento participating in the project. The intervention programme lasts 12 weeks and is divided into two blocks. During Block 1 (8 weeks), participants will complete the motor exercise battery twice weekly in the school setting, under the supervision of Abilnova educators. Sessions will take place twice a week, last approximately 45-60 minutes, and will be accompanied by fortnightly group meetings with classmates aimed at promoting social inclusion. During Block 2 (4 weeks), participants will perform the exercises at home, with the aim of consolidating the skills acquired and promoting autonomy in carrying out physical activity exercises, while continuing the fortnightly peer sessions at school. The effectiveness of the programme will be evaluated using a pre-post design (T0-T1), with an intermediate assessment at the end of Block 1 (T0.5). An integrated assessment system will be used, including ComfTech® wearable devices for continuous monitoring of physiological parameters, such as heart rate, respiratory rate, body temperature, SpO₂, and ECG; video systems for the assessment of motor and postural performance; standardised questionnaires assessing quality of life and social participation; and structured observation grids during peer sessions. Data will be transmitted to the AVATAR system, a conversational system developed within the project, which processes physiological and kinematic information in real time. AVATAR does not operate autonomously and does not make medical decisions. The results will contribute to validating an adapted, sustainable, and transferable exercise battery, laying the foundations for large-scale applications in clinical, educational, and rehabilitation settings, with potentially significant benefits for the quality of life and autonomy of young people with VI.

Вмешательства

• Поведенческое Adapted Physical Activity Programme
  A 12-week adapted physical activity programme for children and adolescents with VI. During the first 8 weeks, participants will complete two supervised school-based exercise sessions per week, each lasting approximately 45-60 minutes, under the supervision of trained Abilnova educators. Fortnightly peer-group sessions with classmates will also be conducted to promote social inclusion. During the final 4 weeks, participants will perform the exercise programme at home to consolidate acquired motor

Первичные конечные точки

• Feasibility of the Adapted Physical Activity Programme [Срок оценки: Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.]
• Acceptability of the Adapted Physical Activity Programme [Срок оценки: After 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.]
• Change in Movement Amplitude [Срок оценки: Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.]
• Change in Movement Execution Speed [Срок оценки: Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.]
• Change in Postural Stability [Срок оценки: Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.]
• Change in Heart Rate [Срок оценки: Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.]
• Change in Respiratory Rate [Срок оценки: Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.]
• Change in Peripheral Oxygen Saturation [Срок оценки: Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.]
• Change in Body Temperature [Срок оценки: Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.]
• Change in Electrocardiographic Parameters [Срок оценки: Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.]

Критерии участия

Критерии включения

• Aged 10 to 17 years.
• Diagnosis of Visual Impairment (VI), defined as a congenital or acquired impairment of visual functioning that cannot be corrected solely through the use of glasses or contact lenses.
• Ability to participate in the exercise protocol, with adapted instructions or support where necessary.

Критерии исключения

• Presence of severe neurological, orthopaedic, or cardiac conditions that contraindicate moderate physical exercise.
• Current pregnancy.
• Conditions preventing the safe use of wearable devices, such as severe skin allergies or incompatible medical devices.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Department of Psychology and Cognitive Science — Rovereto

Публикации

• Wagner MO, Haibach PS, Lieberman LJ. Gross motor skill performance in children with and without visual impairments--research to practice. Res Dev Disabil. 2013 Oct;34(10):3246-52. doi: 10.1016/j.ridd.2013.06.030. Epub 2013 Jul 25. PMID 23891733
• Rogge AK, Hamacher D, Cappagli G, Kuhne L, Hotting K, Zech A, Gori M, Roder B. Balance, gait, and navigation performance are related to physical exercise in blind and visually impaired children and adolescents. Exp Brain Res. 2021 Apr;239(4):1111-1123. doi: 10.1007/s00221-021-06038-3. Epub 2021 Feb 7. PMID 33550429
• Lanza M, Incagli F, Ceccato C, Reffo ME, Mercuriali E, Parmeggiani F, Pagliano E, Saletti V, Leonardi M, Suppiej A, Dollfus H, LeBreton D, Finger RP, Leroy BP, Zemaitiene R, Nowomiejska K, Guastafierro E. Quality of life, functioning and participation of children and adolescents with visual impairment: A scoping review. Res Dev Disabil. 2024 Aug;151:104772. doi: 10.1016/j.ridd.2024.104772. Epub 20 PMID 38870675
• Haegele JA, Porretta D. Physical activity and school-age individuals with visual impairments: a literature review. Adapt Phys Activ Q. 2015 Jan;32(1):68-82. doi: 10.1123/apaq.2013-0110. PMID 25544721
• Gori M, Cappagli G, Tonelli A, Baud-Bovy G, Finocchietti S. Devices for visually impaired people: High technological devices with low user acceptance and no adaptability for children. Neurosci Biobehav Rev. 2016 Oct;69:79-88. doi: 10.1016/j.neubiorev.2016.06.043. Epub 2016 Jul 30. PMID 27484870
• Furtado OL, Allums-Featherston K, Lieberman LJ, Gutierrez GL. Physical activity interventions for children and youth with visual impairments. Adapt Phys Activ Q. 2015 Apr;32(2):156-76. doi: 10.1123/APAQ.2014-0164. PMID 25799595
• Elsman EBM, Koel M, van Nispen RMA, van Rens GHMB. Quality of Life and Participation of Children With Visual Impairment: Comparison With Population Reference Scores. Invest Ophthalmol Vis Sci. 2021 Jun 1;62(7):14. doi: 10.1167/iovs.62.7.14. PMID 34115092
• Bakke HA, Cavalcante WA, de Oliveira IS, Sarinho SW, Cattuzzo MT. Assessment of Motor Skills in Children With Visual Impairment: A Systematic and Integrative Review. Clin Med Insights Pediatr. 2019 May 6;13:1179556519838287. doi: 10.1177/1179556519838287. eCollection 2019. PMID 31105435

Идентификаторы

NCT: NCT07703150 · 26/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗