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

NCT07703150 | Not Yet Recruiting

• 1 other identifier: 26/2026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Visual Impairment; Cerebral Visual Impairment; Visual Impairments

Keywords

Physical Activity; Visual Impairment; Psychophysical Well-being; Physiological Monitoring; Social Inclusion

Outcome Measures

Primary Outcomes (13)

• Feasibility of the Adapted Physical Activity Programme

  Feasibility will be assessed through session completion rates across the school-based and home-based intervention blocks and adherence to planned procedures. Feasibility indicators will be reported as percentages, with higher percentages indicating greater feasibility of the programme.

  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

  Acceptability will be assessed through the participant-rated acceptability of the programme using a 5-point Likert scale administered via the AVATAR system. Acceptability scores range from 1 to 5, with higher scores indicating greater acceptability of the programme.

  After 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.

• Change in Movement Amplitude

  Changes in movement amplitude will be assessed using video-based analysis during the adapted exercise battery. Movement amplitude will be quantified as the range of motion of selected body segments during predefined motor tasks.

  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

  Changes in movement execution speed will be assessed using video-based analysis during the adapted exercise battery. Execution speed will be quantified as the time required to complete predefined motor tasks.

  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

  Changes in postural stability will be assessed using video-based analysis during the adapted exercise battery. Postural stability will be quantified through indicators of balance control during predefined standing and movement tasks.

  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

  Changes in heart rate will be assessed through real-time monitoring with ComfTech® wearable devices. Heart rate will be reported in beats per minute.

  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

  Changes in respiratory rate will be assessed through real-time monitoring with ComfTech® wearable devices. Respiratory rate will be reported in breaths per minute.

  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

  Changes in peripheral oxygen saturation will be assessed through real-time monitoring with ComfTech® wearable devices. Peripheral oxygen saturation will be reported as the percentage of oxygen-saturated hemoglobin in the blood.

  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

  Changes in body temperature will be assessed through real-time monitoring with ComfTech® wearable devices. Body temperature will be reported in degrees Celsius.

  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

  Changes in electrocardiographic parameters will be assessed through real-time monitoring with ComfTech® wearable devices. Electrocardiographic data will be used to derive cardiac rhythm-related parameters during the adapted exercise battery.

  Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.

• Change in Pediatric Quality of Life

  Changes in pediatric quality of life will be assessed using the Pediatric Quality of Life Inventory Version 4.0. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The questionnaire will be completed using participant self-report and parent proxy-report versions, where applicable.

  Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.

• Change in Vision-Related Quality of Life

  Changes in vision-related quality of life will be assessed using the Impact of Visual Impairment for Children questionnaire. Scores will be reported on a logit scale. Higher scores indicate better vision-related quality of life.

  Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.

• Change in Social Participation

  Changes in social participation will be assessed using the Child and Adolescent Scale of Participation. Scores range from 0 to 100, with higher scores indicating greater age-expected participation and therefore better social participation. The questionnaire will be completed using participant self-report and parent proxy-report versions, where applicable.

  Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.

Study Arms (1)

Adapted Physical Activity Programme

EXPERIMENTAL

VI participants will receive a 12-week adapted physical activity programme. During the first 8 weeks, they will attend two supervised school-based exercise sessions per week (approximately 45-60 minutes each), alongside fortnightly peer-group sessions to promote social inclusion. During the final 4 weeks, participants will perform the exercises at home to consolidate acquired skills and support autonomy, while continuing fortnightly peer sessions at school.

Behavioral: Adapted Physical Activity Programme

Interventions

Adapted Physical Activity Programme BEHAVIORAL

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 skills and foster autonomy, while continuing the fortnightly peer sessions at school. The programme includes adapted motor, postural, and physical activity exercises tailored to participants' functional abilities.

Adapted Physical Activity Programme

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Trento: lead

Study Sites (1)

Department of Psychology and Cognitive Science

Rovereto, Trento, 38068, Italy

Location

Related Publications (9)

• 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 RESULT

• 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 RESULT

• 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 2024 Jun 12.

  PMID: 38870675 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Alcaraz-Rodriguez V, Medina-Rebollo D, Munoz-Llerena A, Fernandez-Gavira J. Influence of Physical Activity and Sport on the Inclusion of People with Visual Impairment: A Systematic Review. Int J Environ Res Public Health. 2021 Dec 31;19(1):443. doi: 10.3390/ijerph19010443.

  PMID: 35010704 RESULT

MeSH Terms

Conditions

Vision Disorders; Blindness, Cortical; Motor Activity; Social Inclusion

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blindness; Behavior; Social Behavior

Central Study Contacts

Paola Venuti, PhD

CONTACT

+39 0464 808451; paola.venuti@unitn.it

Micol Gemignani, PhD

CONTACT

micol.gemignani@unitn.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-06

Locations

IT (1)