- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06628999
Perceptual-vision Training and Intellectual Disabilities
Perceptual-vision Training as a Strategy for Healthy Ageing in Adults With Intellectual Disability
Study Overview
Status
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age between 40 and 70 years
- mild ID (Intellectual Quotient = 51-69).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Visual Training Group
Visual Training Group: physical training exercises aiming to combine visual skills with basic motor actions for 16 consecutive weeks
|
16-week training protocol focused on visual training designed for ameliorating cognitive performance and physical fitness
|
|
Active Comparator: Control Group
Control Group: active lifestyle based on healthy habits for 16 consecutive weeks
|
16-week of active lifestyle based on healthy habits
|
|
Experimental: Visual Training-detraining Group
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to sixteen weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline static balance at 16 week
Time Frame: Up to sixteen weeks
|
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
|
Up to sixteen weeks
|
|
Change from baseline strength at 16 week
Time Frame: Up to sixteen weeks
|
Maximal isometric grip in kilograms using the handgrip dynamometer
|
Up to sixteen weeks
|
|
Change from baseline strength at 16 week
Time Frame: Up to sixteen weeks
|
Amount of time in seconds during a chair rise for five consecutive times adopting the Five Repetition sit to stand test
|
Up to sixteen weeks
|
|
Change from baseline movement agility at 16 week
Time Frame: Up to sixteen weeks
|
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
|
Up to sixteen weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Luca Cavaggioni, PhD, Universitià degli Studi dell'Insubria
Publications and helpful links
General Publications
- Formenti 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.
- Erickson 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.
- 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.
- Forte 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.
- Giuliani 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.
- Henderson 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.
- Horner-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.
- Krahn 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.
- Santos 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.
- Wollesen 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.
- Cavaggioni 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Intellectual Disability
- Motor Activity
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- 0119168
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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