Sensory Integration Training for Older Adults With Mild Cognitive Impairment

March 10, 2026 updated by: Fatmagul Cayir, Akdeniz University

Investigation of the Effects of Sensory Integration Training on Cognitive Functions, Quality of Life, and Social Participation in Older Adults With Mild Cognitive Impairment

This study aims to investigate the effects of sensory integration training on cognitive functions, quality of life, and social participation in older adults with Mild Cognitive Impairment (MCI)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Aerobic Exercise
Other: 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
Experimental: Aerobic Exercise +Sensory Integration Training
Other: 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
Other: Sensory Integration Training
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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:

  1. Orientation: (Questioning the country, year, month, day, and date - approx. 1 minute - 10 points)
  2. Registration: (Working memory; repeating 5 given words - 30 seconds - 5 points)
  3. Clock Drawing: (Visuospatial; drawing a clock within 1 minute - 15 points)
  4. Delayed Recall: (Episodic memory; recalling the 5 previously mentioned words - 30 seconds - 20 points)
  5. Verbal Fluency: (Semantic memory/language; naming animals within 1 minute - 20 points)
  6. Logical Memory: (Episodic memory; repeating a short story - 1 minute - 30 points)

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AkdenizU-SBF-FC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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