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NCT Number: NCT07703150

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

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.

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Key information

Conditions

Visual Impairment Behavior Blindness Blindness, Cortical Cerebral Visual Impairment Eye Diseases Motor Activity Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Social Behavior Social Inclusion Vision Disorders Visual Impairments

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology and Cognitive Science

Rovereto, Trento, 38068, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of the Adapted Physical Activity Programme

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

    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.

  2. Acceptability of the Adapted Physical Activity Programme

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

    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.

  3. Change in Movement Amplitude

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

    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.

  4. Change in Movement Execution Speed

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

    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.

  5. Change in Postural Stability

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

    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.

  6. Change in Heart Rate

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

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

  7. Change in Respiratory Rate

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

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

  8. Change in Peripheral Oxygen Saturation

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

    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.

  9. Change in Body Temperature

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

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

  10. Change in Electrocardiographic Parameters

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

    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.

  11. Change in Pediatric Quality of Life

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

    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.

  12. Change in Vision-Related Quality of Life

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

    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.

  13. Change in Social Participation

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

    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.

Study contacts

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

Micol Gemignani, PhD

CONTACT

[email protected]

Paola Venuti, PhD

CONTACT

[email protected]

+39 0464 808451

Sponsors and collaborators

Lead sponsor

Università degli Studi di Trento

Other

Registry information

Official study title

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

Acronym: VIPPSTAR_UNITN

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 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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