An interventional study of Adapted Physical Activity Programme in Visual Impairment, Cerebral Visual Impairment and Visual Impairments, sponsored by Università degli Studi di Trento. Not yet recruiting at 1 site in Italy. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Università degli Studi di Trento · Not applicable, Interventional, and Supportive care
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.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's planned enrollment of 20 is below the median of 78 across 244 interventional studies indexed under Vision Disorders.
Browse Vision Disorders studies →Università degli Studi di Trento is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline before intervention; after 8 weeks of intervention, at the end of Block 1; immediately after the intervention, up to 12 weeks.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Università degli Studi di Trento