Intellectual DisabilityNCT06628999
Perceptual-vision Training and Intellectual Disabilities
A study testing Visual Training and Visual Training-detraining in people with Intellectual Disability and Intellectual Impairment, run by Università degli Studi dell'Insubria.
Trial summary
Physical activity for healthy ageing is an important feature and the possibility to detect practical solutions to solve the need for feasible health promotion interventions to reduce health disparities and wellbeing in individuals with intellectual disability (ID) is an open question. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability, Intellectual Impairment, Activity, Motor
- What is being tested?
- Visual Training and Visual Training-detraining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 40 and 70 years
- mild ID (Intellectual Quotient = 51-69).
Who cannot join
- inability to understand basic verbal communication
- strict dependence on personnel or assistive support devices
- presence of concomitant sensorial or physical impairments
- presence of behavioural problems or any other clinical condition that may compromise the regular physical activity practice
About this study
Official title: Perceptual-vision Training as a Strategy for Healthy Ageing in Adults With Intellectual Disability
Physical activity for healthy ageing is an important feature and the possibility to detect practical solutions to solve the need for feasible health promotion interventions to reduce health disparities and wellbeing in individuals with intellectual disability (ID) is an open question. In this perspective, vision has a remarkable role in spatial cognition and organization, especially in individuals with ID. Therefore, the aim is to investigate the effectiveness of a perceptual-vision training program on cognitive performance (inhibitory control) and physical fitness (balance, agility and muscular strength) in adults with ID throughout 16 weeks. Participants with mild ID will be randomly divided into a perceptual-vision training group, a perceptual-vision training-detraining group and a control group. Cognitive performance and physical fitness will be assessed at baseline, mid and at the end of 16 weeks. In conclusion, a visual training program may present the potentiality to impact various health domains, from cognition to physical performance in individuals with intellectual disabilities, promoting their healthy aging.
Read the detailed description
Despite the importance of physical activity for healthy ageing and the need for feasible health promotion interventions to reduce health disparities and improve aging wellbeing in individuals with intellectual disability (ID), there is a lack of empirically supported strategies for health promotion and disease prevention in adults with ID. Notably, vision and eye tracking play a key role in spatial cognition and orientation triggering several brain areas and people with ID may present anomalous visual movements, spatial organization or cognitive performance. The aim of the present project is to investigate a potential strategy for promoting healthy ageing targeting both physical and cognitive domains in individuals with ID. Specifically, this project will study the effect of a perceptual-vision training program on cognitive performance (inhibitory control) and physical fitness (balance, agility and muscular strength) in adults with ID. The second aim is to test the association between cognitive and physical performance variables. Participants with mild ID will be randomly allocated to a perceptual-vision training group (n = 28), a perceptual-vision training-detraining group (n = 28) and a control group (n = 28).
During the overall 16 weeks, the perceptual-vision training group will follow an intervention protocol based on vision and oculomotor exercises combined with balance motor actions for the entire period, the perceptual-vision training-detraining group will follow the same oculomotor training program for 8 weeks and a period of detraining for the last consecutive 8 weeks. Lastly, the control group will continue to perform habitual active lifestyle for 16 weeks. Cognitive performance and physical fitness will be assessed at baseline, mid (end of 8 week), and post intervention period (end of 16 week). Overall, a perceptual-vision training program may have the potential to positively impact various aspects of life quality in individuals with ID promoting autonomy, health, social integration, and overall wellbeing. This may be a promising strategy to ameliorate healthy ageing of people with ID across various domains.
- Conditions
- Intellectual Disability, Intellectual Impairment, Activity, Motor, Sports Physical Therapy
- Being tested
- Visual Training, Control Group, Visual Training-detraining
- Keywords
- Visual training, Intellectual disability, Physical activity
- Medical subject headings
- Intellectual Disability, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual TrainingOther
16-week training protocol focused on visual training designed for ameliorating cognitive performance and physical fitness
Control GroupOther
16-week of active lifestyle based on healthy habits
Visual Training-detrainingOther
8-week training protocol focused on visual training designed for ameliorating cognitive performance and physical fitness, followed by 8 week with no specific training protocol
| Study group | Role | What they receive |
|---|---|---|
| Visual Training Group | Experimental | Visual Training Group: physical training exercises aiming to combine visual skills with basic motor actions for 16 consecutive weeks Receives: Other: Visual Training |
| Control Group | Active comparator | Control Group: active lifestyle based on healthy habits for 16 consecutive weeks Receives: Other: Control Group |
| Visual Training-detraining Group | Experimental | Visual Training-detraining Group: physical exercises physical training exercises aiming to combine visual skills with basic motor actions for 8 consecutive weeks. The last remaining 8 weeks (up to 16 week) the group will conduct a period of detraining in which no physical exercises will be administered Receives: Other: Visual Training-detraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline cognitive performance at 16 week
Response time on a computerized test conceptualized as a measure of cognitive performance inhibitory control (Modified Flanker Task test). Participants are tasked with identifying the direction of the central target stimulus that is flanked by either congruent (<<<<<) or incongruent (>><>>) stimuli by pressing the correct keyboard key.
Measured: Up to sixteen weeks
Secondary outcomes (4)
Change from baseline static balance at 16 week
Postural control detected in standing position with eyes closed using the Balance Error Scoring System protocol in arbitrary units using a 0-30 point scale in which lower scores mean a better outcome result
Measured: Up to sixteen weeks
Change from baseline strength at 16 week
Maximal isometric grip in kilograms using the handgrip dynamometer
Measured: Up to sixteen weeks
Change from baseline strength at 16 week
Amount of time in seconds during a chair rise for five consecutive times adopting the Five Repetition sit to stand test
Measured: Up to sixteen weeks
Change from baseline movement agility at 16 week
Amount of time in seconds using the Time Up and Go test. The test begins with the participant that should stand up from a chair, he has to walk forward for three meters, then to come back and to sit down on a chair. During the entire procedure the participant should count backward by three starting from a casual number
Measured: Up to sixteen weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start5 May 2025 (estimated)
- Primary completion28 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: The study was withdrawn prior to enrollment due to organizational and logistical issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Cavaggioni, Università degli Studi dell'Insubria
- Investigators
- Luca Cavaggioni, PhD, Principal investigator, Universitià degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628999
- Sponsor's protocol ID
- 0119168
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carmeli E, Imam B. Health promotion and disease prevention strategies in older adults with intellectual and developmental disabilities. Front Public Health. 2014 Apr 14;2:31. doi: 10.3389/fpubh.2014.00031. eCollection 2014.
PubMed 24783190Erickson KI, Hillman C, Stillman CM, Ballard RM, Bloodgood B, Conroy DE, Macko R, Marquez DX, Petruzzello SJ, Powell KE; FOR 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Physical Activity, Cognition, and Brain Outcomes: A Review of the 2018 Physical Activity Guidelines. Med Sci Sports Exerc. 2019 Jun;51(6):1242-1251. doi: 10.1249/MSS.0000000000001936.
PubMed 31095081Formenti D, Duca M, Trecroci A, Ansaldi L, Bonfanti L, Alberti G, Iodice P. Perceptual vision training in non-sport-specific context: effect on performance skills and cognition in young females. Sci Rep. 2019 Dec 10;9(1):18671. doi: 10.1038/s41598-019-55252-1.
PubMed 31822740Forte R, Trentin C, Tocci N, Lucia S, Aydin M, Di Russo F. Motor-cognitive exercise with variability of practice and feedback improves functional ability and cognition in older individuals. Aging Clin Exp Res. 2023 Nov;35(11):2797-2806. doi: 10.1007/s40520-023-02568-8. Epub 2023 Oct 19.
PubMed 37853304Giuliani F, Favrod J, Grasset F, Schenk F. Accurate memory for object location by individuals with intellectual disability: absolute spatial tagging instead of configural processing? Res Dev Disabil. 2011 May-Jun;32(3):986-94. doi: 10.1016/j.ridd.2011.01.055. Epub 2011 Feb 24.
PubMed 21353464Henderson JM. Human gaze control during real-world scene perception. Trends Cogn Sci. 2003 Nov;7(11):498-504. doi: 10.1016/j.tics.2003.09.006.
PubMed 14585447Horner-Johnson W, Bailey D. Assessing Understanding and Obtaining Consent from Adults with Intellectual Disabilities for a Health Promotion Study. J Policy Pract Intellect Disabil. 2013 Sep;10(3):10.1111/jppi.12048. doi: 10.1111/jppi.12048.
PubMed 24223054Krahn GL, Fox MH. Health disparities of adults with intellectual disabilities: what do we know? What do we do? J Appl Res Intellect Disabil. 2014 Sep;27(5):431-46. doi: 10.1111/jar.12067. Epub 2013 Jul 31.
PubMed 23913632Santos FH, Zurek J, Janicki MP. Efficacy of Healthy Aging Interventions for Adults With Intellectual and Developmental Disabilities: A Systematic Review. Gerontologist. 2022 Apr 20;62(4):e235-e252. doi: 10.1093/geront/gnaa192.
PubMed 33220058Wollesen B, Wildbredt A, van Schooten KS, Lim ML, Delbaere K. The effects of cognitive-motor training interventions on executive functions in older people: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2020 Jul 2;17:9. doi: 10.1186/s11556-020-00240-y. eCollection 2020.
PubMed 32636957Cavaggioni L, Formenti D, Castiglioni P, Ardigo LP, Merati G. Perceptual-vision training as a strategy for healthy aging in adults with intellectual disability: a study protocol. Front Psychol. 2025 Apr 24;16:1526826. doi: 10.3389/fpsyg.2025.1526826. eCollection 2025.
PubMed 40342338
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptual-vision Training as a Strategy for Healthy Ageing in Adults With Intellectual Disability
- ClinicalTrials.gov ID
- NCT06628999
- Acronym / sponsor ID
- 0119168
- Conditions
- Intellectual Disability, Intellectual Impairment, Activity, Motor, Sports Physical Therapy
- Keywords
- Visual training, Intellectual disability, Physical activity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn prior to enrollment due to organizational and logistical issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 5 May 2025 (estimated)
- Primary completion
- 28 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical activity for healthy ageing is an important feature and the possibility to detect practical solutions to solve the need for feasible health promotion interventions to reduce health disparities and wellbeing in individuals with intellectual disability (ID) is an open question. In this perspective, vision has a remarkable role in spatial cognition and organization, especially in individuals with ID. Therefore, the aim is to investigate the effectiveness of a perceptual-vision training program on cognitive performance (inhibitory control) and physical fitness (balance, agility and muscular strength) in adults with ID throughout 16 weeks. Participants with mild ID will be randomly divided into a perceptual-vision training group, a perceptual-vision training-detraining group and a control group. Cognitive performance and physical fitness will be assessed at baseline, mid and at the end of 16 weeks. In conclusion, a visual training program may present the potentiality to impact various health domains, from cognition to physical performance in individuals with intellectual disabilities, promoting their healthy aging.
Detailed description
Despite the importance of physical activity for healthy ageing and the need for feasible health promotion interventions to reduce health disparities and improve aging wellbeing in individuals with intellectual disability (ID), there is a lack of empirically supported strategies for health promotion and disease prevention in adults with ID. Notably, vision and eye tracking play a key role in spatial cognition and orientation triggering several brain areas and people with ID may present anomalous visual movements, spatial organization or cognitive performance. The aim of the present project is to investigate a potential strategy for promoting healthy ageing targeting both physical and cognitive domains in individuals with ID. Specifically, this project will study the effect of a perceptual-vision training program on cognitive performance (inhibitory control) and physical fitness (balance, agility and muscular strength) in adults with ID. The second aim is to test the association between cognitive and physical performance variables. Participants with mild ID will be randomly allocated to a perceptual-vision training group (n = 28), a perceptual-vision training-detraining group (n = 28) and a control group (n = 28).
During the overall 16 weeks, the perceptual-vision training group will follow an intervention protocol based on vision and oculomotor exercises combined with balance motor actions for the entire period, the perceptual-vision training-detraining group will follow the same oculomotor training program for 8 weeks and a period of detraining for the last consecutive 8 weeks. Lastly, the control group will continue to perform habitual active lifestyle for 16 weeks. Cognitive performance and physical fitness will be assessed at baseline, mid (end of 8 week), and post intervention period (end of 16 week). Overall, a perceptual-vision training program may have the potential to positively impact various aspects of life quality in individuals with ID promoting autonomy, health, social integration, and overall wellbeing. This may be a promising strategy to ameliorate healthy ageing of people with ID across various domains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Visual Training Group | Experimental | Other: Visual TrainingVisual Training Group: physical training exercises aiming to combine visual skills with basic motor actions for 16 consecutive weeks |
| Control Group | Active comparator | Other: Control GroupControl Group: active lifestyle based on healthy habits for 16 consecutive weeks |
| Visual Training-detraining Group | Experimental | Other: Visual Training-detrainingVisual Training-detraining Group: physical exercises physical training exercises aiming to combine visual skills with basic motor actions for 8 consecutive weeks. The last remaining 8 weeks (up to 16 week) the group will conduct a period of detraining in which no physical exercises will be administered |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 40 and 70 years
- mild ID (Intellectual Quotient = 51-69).
Key exclusion criteria (4 listed)
- inability to understand basic verbal communication
- strict dependence on personnel or assistive support devices
- presence of concomitant sensorial or physical impairments
- presence of behavioural problems or any other clinical condition that may compromise the regular physical activity practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Training16-week training protocol focused on visual training designed for ameliorating cognitive performance and physical fitness | Other | Visual Training Group |
| Control Group16-week of active lifestyle based on healthy habits | Other | Control Group |
| Visual Training-detraining8-week training protocol focused on visual training designed for ameliorating cognitive performance and physical fitness, followed by 8 week with no specific training protocol | Other | Visual Training-detraining Group |
Primary outcome
Change from baseline cognitive performance at 16 week
Time frame: Up to sixteen weeks
Response time on a computerized test conceptualized as a measure of cognitive performance inhibitory control (Modified Flanker Task test). Participants are tasked with identifying the direction of the central target stimulus that is flanked by either congruent (<<<<<) or incongruent (>><>>) stimuli by pressing the correct keyboard key.
4 secondary outcomes
Change from baseline static balance at 16 week
Time frame: Up to sixteen weeks
Change from baseline strength at 16 week
Time frame: Up to sixteen weeks
Change from baseline strength at 16 week
Time frame: Up to sixteen weeks
Change from baseline movement agility at 16 week
Time frame: Up to sixteen weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 24783190Carmeli E, Imam B. Health promotion and disease prevention strategies in older adults with intellectual and developmental disabilities. Front Public Health. 2014 Apr 14;2:31. doi: 10.3389/fpubh.2014.00031. eCollection 2014.
- Background: PubMed 31095081Erickson KI, Hillman C, Stillman CM, Ballard RM, Bloodgood B, Conroy DE, Macko R, Marquez DX, Petruzzello SJ, Powell KE; FOR 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Physical Activity, Cognition, and Brain Outcomes: A Review of the 2018 Physical Activity Guidelines. Med Sci Sports Exerc. 2019 Jun;51(6):1242-1251. doi: 10.1249/MSS.0000000000001936.
- Background: PubMed 31822740Formenti D, Duca M, Trecroci A, Ansaldi L, Bonfanti L, Alberti G, Iodice P. Perceptual vision training in non-sport-specific context: effect on performance skills and cognition in young females. Sci Rep. 2019 Dec 10;9(1):18671. doi: 10.1038/s41598-019-55252-1.
- Background: PubMed 37853304Forte R, Trentin C, Tocci N, Lucia S, Aydin M, Di Russo F. Motor-cognitive exercise with variability of practice and feedback improves functional ability and cognition in older individuals. Aging Clin Exp Res. 2023 Nov;35(11):2797-2806. doi: 10.1007/s40520-023-02568-8. Epub 2023 Oct 19.
- Background: PubMed 21353464Giuliani F, Favrod J, Grasset F, Schenk F. Accurate memory for object location by individuals with intellectual disability: absolute spatial tagging instead of configural processing? Res Dev Disabil. 2011 May-Jun;32(3):986-94. doi: 10.1016/j.ridd.2011.01.055. Epub 2011 Feb 24.
- Background: PubMed 14585447Henderson JM. Human gaze control during real-world scene perception. Trends Cogn Sci. 2003 Nov;7(11):498-504. doi: 10.1016/j.tics.2003.09.006.
- Background: PubMed 24223054Horner-Johnson W, Bailey D. Assessing Understanding and Obtaining Consent from Adults with Intellectual Disabilities for a Health Promotion Study. J Policy Pract Intellect Disabil. 2013 Sep;10(3):10.1111/jppi.12048. doi: 10.1111/jppi.12048.
- Background: PubMed 23913632Krahn GL, Fox MH. Health disparities of adults with intellectual disabilities: what do we know? What do we do? J Appl Res Intellect Disabil. 2014 Sep;27(5):431-46. doi: 10.1111/jar.12067. Epub 2013 Jul 31.
- Background: PubMed 33220058Santos FH, Zurek J, Janicki MP. Efficacy of Healthy Aging Interventions for Adults With Intellectual and Developmental Disabilities: A Systematic Review. Gerontologist. 2022 Apr 20;62(4):e235-e252. doi: 10.1093/geront/gnaa192.
- Background: PubMed 32636957Wollesen B, Wildbredt A, van Schooten KS, Lim ML, Delbaere K. The effects of cognitive-motor training interventions on executive functions in older people: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2020 Jul 2;17:9. doi: 10.1186/s11556-020-00240-y. eCollection 2020.
- Derived from this study: PubMed 40342338Cavaggioni L, Formenti D, Castiglioni P, Ardigo LP, Merati G. Perceptual-vision training as a strategy for healthy aging in adults with intellectual disability: a study protocol. Front Psychol. 2025 Apr 24;16:1526826. doi: 10.3389/fpsyg.2025.1526826. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Cavaggioni, PhD principal investigator
Universitià degli Studi dell'Insubria
Questions about this trial
What is this clinical trial studying?
A study testing Visual Training and Visual Training-detraining in people with Intellectual Disability and Intellectual Impairment, run by Università degli Studi dell'Insubria.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline cognitive performance at 16 week (time frame: Up to sixteen weeks). 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 NCT06628999, which also lists 11 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 6 May 2026.