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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorUniversità degli Studi di Trento

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Adapted Physical Activity ProgrammeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: