- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07466615
Sensory Integration Training for Older Adults With Mild Cognitive Impairment
Investigation of the Effects of Sensory Integration Training on Cognitive Functions, Quality of Life, and Social Participation in Older Adults With Mild Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sensory impairments are highly prevalent among older adults and have significant effects on the cognitive and functional outcomes of aging. Although the relationship between sensory functions and cognitive processes has been clearly established in the literature, the underlying neurobiological and psychosocial mechanisms of this link are yet to be fully elucidated. In an era of increasing dementia prevalence, older individuals with sensory deficiencies constitute a critical and growing risk group that warrants investigation for a deeper understanding of cognitive aging. Epidemiological data indicate that impairments in visual, auditory, and other individual sensory systems are consistently associated with cognitive decline and the development of dementia.
In this context, our study proposes sensory integration training as a potential intervention to bridge the gap between sensory input and cognitive performance.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fatmagül Çayır
- Phone Number: + 90 530 0369530
- Email: fatmagul.cayir@hotmail.com
Study Locations
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-
Merkez
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Isparta, Merkez, Turkey (Türkiye)
- Isparta Şehir Hastanesi
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Contact:
- Fatmagül Çayır
- Phone Number: + 90 530 0369530
- Email: fatmagul.cayir@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 65 and 85 years of age
- Having a Montreal Cognitive Assessment (MoCA) score between 18 and 25, indicating mild cognitive impairment
- Being in stable medical health, with no history of severe neurological or psychiatric disorders
- Voluntary participation
Exclusion Criteria:
- Clinical diagnosis of dementia or having moderate-to-severe cognitive impairment
- Severe visual or hearing loss to a degree that prevents effective communication or participation in assessments
- Presence of severe sensory, motor, or physical disabilities that render the intervention (e.g., walking or sensory training) impossible to perform
- Acute medical conditions or having unstable chronic diseases that may pose a risk during physical activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Aerobic Exercise
|
The aerobic exercise intervention consists of a 12-week outdoor walking program, performed twice weekly for 45 minutes per session at a moderate intensity, targeting a score of 12-14 on the Borg Rating of Perceived Exertion (RPE) scale
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Experimental: Aerobic Exercise +Sensory Integration Training
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The aerobic exercise intervention consists of a 12-week outdoor walking program, performed twice weekly for 45 minutes per session at a moderate intensity, targeting a score of 12-14 on the Borg Rating of Perceived Exertion (RPE) scale
The program includes activities that stimulate three main senses: vestibular (balance and movement), proprioceptive (body awareness), and tactile (touch).
These exercises are designed to help the brain organize sensory signals more effectively to improve daily functions and cognitive performance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick Mild Cognitive Impairment Screen - Turkish Version
Time Frame: 6 months
|
Quick Mild Cognitive Impairment Screen - Turkish Version is a cognitive assessment tool consisting of six sub-headings covering at least five cognitive domains. The sub-headings and the cognitive domains they assess are defined as follows:
Scoring and Interpretation The test is evaluated out of a total of 100 points, where higher scores indicate better cognitive status. A score of 62 points or below indicates cognitive impairment. |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
World Health Organization Quality of Life - Older Adults Module
Time Frame: 6 months
|
World Health Organization Quality of Life-Old module is a specialized 24-item instrument designed to evaluate the quality of life in older adults across six distinct domains, utilized via a five-point Likert scale.
These domains include sensory abilities, which assesses the impact of sensory functions and their loss on quality of life; autonomy, reflecting independence and the ability to live and make decisions autonomously; past, present, and future activities, which measures satisfaction with life achievements and outlook on the future; social participation, focusing on engagement in daily community activities; death and dying, addressing concerns and anxieties related to the end of life; and intimacy, evaluating the capacity for personal and private relationships.
Each item is scored on a scale from 1.0 to 5.0, resulting in potential domain scores ranging from a minimum of 4 to a maximum of 20.
A total cumulative score is calculated by summing the individual item v
|
6 months
|
|
Lubbes Social Network Scale-6
Time Frame: 6 months
|
Lubbes Social Network Scale-6 is a specialized instrument comprising six items designed to evaluate the size of a social network, private communication (confiding), and the availability of reciprocal help.
The scale is structured into two subscales, with three questions dedicated to family ties and three to friendship networks.
Consistent with the original version, each item is rated on a six-point Likert scale ranging from 0 to 5. In this scoring system, individual scores of 0, 1, and 2 indicate a limited or deficient social network, whereas scores of 3, 4, and 5 signify a more extensive and robust social network.
The total score is calculated by summing the values of all items, resulting in a range from 0 to 30.
Higher total scores on the LSNS-6 are indicative of a greater presence of social network ties and more significant social engagement.
|
6 months
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AkdenizU-SBF-FC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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