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Visual ImpairmentVIPPSTAR_UNITNNCT07703150

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

A study testing Adapted Physical Activity Programme in people with Visual Impairment and Cerebral Visual Impairment, run by Università degli Studi di Trento at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
What is being tested?
Adapted Physical Activity Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
1 Jan 2027to 31 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Paola Venuti, PhD contact

+39 0464 808451

paola.venuti@unitn.it

Micol Gemignani, PhD contact

micol.gemignani@unitn.it

Italy1 site
  • Department of Psychology and Cognitive Science

    Rovereto, Trento, 38068

Other trials in Italy

About this study

Official title: Promoting the Psychophysical Well-Being of 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.

Read more

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.

Being tested
Adapted Physical Activity Programme
Keywords
Physical Activity, Visual Impairment, Psychophysical Well-being, Physiological Monitoring, Social Inclusion
Medical subject headings
Vision Disorders, Blindness, Cortical, Motor Activity, Social Inclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted Physical Activity ProgrammeBehavioural

    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.

Study groups in NCT07703150
Study groupRoleWhat they receive
Adapted Physical Activity ProgrammeExperimentalVI 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.
Receives: Behavioral: Adapted Physical Activity Programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07703150
Sponsor's protocol ID
26/2026
Acronym
VIPPSTAR_UNITN
Status last verified
Jun 2026
First submitted
29 Jun 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 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.

    PubMed 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 2024 Jun 12.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 31105435
  • 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.

    PubMed 35010704

Questions about this trial

What is this clinical trial studying?

A study testing Adapted Physical Activity Programme in people with Visual Impairment and Cerebral Visual Impairment, run by Università degli Studi di Trento at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paola Venuti, PhD (+39 0464 808451, paola.venuti@unitn.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07703150, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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