Multisensory Environment-Based Occupational Therapy for Alzheimer's Patients

NCT ID: NCT07279103

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-10

Study Completion Date

2026-06-30

Brief Summary

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This study aims to examine the effects of a multisensory environment-based occupational therapy intervention on sensory processing, cognitive status, behavioral and psychological symptoms, and caregiver burden in individuals diagnosed with Alzheimer's disease. Non-pharmacological approaches in Alzheimer's management have been shown to slow functional decline, reduce behavioral symptoms, and improve caregivers' well-being. Multisensory environments provide visual, auditory, tactile, proprioceptive, vestibular, olfactory, and gustatory stimuli to support sensory integration and enhance engagement, particularly in individuals with cognitive and communication difficulties. The study will be conducted using a randomized controlled design and will include individuals aged 65 years and older with moderate-stage Alzheimer's disease and their primary caregivers. The intervention will be implemented over four weeks with two sessions per week. Outcome measures will include the Adult/Adolescent Sensory Profile,Loewenstein Occupational Therapy Cognitive Assessment-Geriatric version, Neuropsychiatric Inventory, and Zarit Caregiver Burden Inventory. The study is expected to contribute to the evidence base supporting sensory-based occupational therapy interventions in dementia care.

Detailed Description

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This study aims to investigate the effects of a multisensory environment-based occupational therapy intervention on sensory processing, cognitive functions, behavioral and psychological symptoms, and caregiver burden in individuals diagnosed with Alzheimer's disease. Alzheimer's disease, as a progressive neurodegenerative condition, leads to gradual impairments in cognitive, emotional, and functional abilities, which in turn cause behavioral disturbances and significantly increase caregiver stress. In recent years, non-pharmacological approaches have gained attention for their role in managing dementia-related symptoms, maintaining daily functioning, and supporting caregivers' well-being.

Multisensory environments, which offer structured stimulation involving visual, auditory, tactile, proprioceptive, vestibular, olfactory, and gustatory senses, are designed to facilitate sensory integration and promote engagement through meaningful sensory experiences. These environments can reduce agitation, enhance communication, and improve mood and attention among individuals with dementia by creating a sense of comfort and familiarity.

This randomized controlled study will include individuals aged 65 years and older who have been clinically diagnosed with moderate-stage Alzheimer's disease, as well as their primary caregivers. The intervention will be implemented over a four-week period, consisting of two 45-minute sessions per week conducted in a controlled multisensory therapy room. Standard care will be provided to the control group.

Outcome measures will include the Adult/Adolescent Sensory Profile to assess sensory processing patterns, the Lowenstein Occupational Therapy Cognitive Assessment for Geriatrics version for cognitive performance, the Neuropsychiatric Inventory for behavioral and psychological symptoms, and the Zarit Caregiver Burden Inventory for caregiver stress. Pre- and post-intervention assessments will be conducted to determine changes in the target variables.

It is anticipated that the multisensory environment-based occupational therapy intervention will positively affect sensory processing and cognitive functions, reduce behavioral and psychological symptoms, and alleviate caregiver burden. The findings of this study are expected to provide strong empirical support for the integration of sensory-based occupational therapy interventions into dementia care programs, contributing to both clinical practice and the growing body of evidence on non-pharmacological rehabilitation approaches for Alzheimer's disease.

Conditions

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Alzheimer s Disease Occupational Therapy Rehabilitation Caregiver Burnout Behavioral and Psychiatric Symptoms of Dementia Sensory Processing Disorder Cognitive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Multisensory Environment-Based Occupational Therapy

Participants in this arm will receive an exploratory, multisensory environment-based occupational therapy program.

Group Type EXPERIMENTAL

Multisensory Environment-Based Occupational Therapy

Intervention Type BEHAVIORAL

Participants will receive a multisensory environment-based occupational therapy intervention designed to expose them to structured sensory experiences. The intervention will last 4 weeks, delivered twice per week, for a total of 8 sessions, each lasting approximately 30 minutes. Sessions will be supportive and exploratory rather than directive.

Before the intervention, each participant's sensory preferences, personal history, and cognitive status will be assessed to individualize the session content. Each session will follow a three-part structure consisting of preparation, main activity, and closing. During the main activity, the therapist will accompany the participant, facilitate engagement, and provide graded sensory options.

The intervention will incorporate visual, auditory, tactile, proprioceptive, vestibular, olfactory, and taste stimuli. Examples include colored lighting, projected images, music, vibration tools, textured materials, movement-based activities, familiar scents

Occupational therapy

Participants in this arm will receive a structured, directive occupational therapy program focusing on cognitive stimulation and daily living activities

Group Type EXPERIMENTAL

Occupational therapy

Intervention Type BEHAVIORAL

The control group will not participate in any multisensory environment-based interventions. Instead, they will receive a directive occupational therapy program focused on cognitive stimulation and promoting independence in daily living activities. The intervention will last 4 weeks, with two sessions per week, totaling 8 sessions, each approximately 30 minutes.

These sessions will not include purposeful multisensory experiences and will follow a structured, cognitively oriented approach tailored to the participant's abilities.

Interventions

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Multisensory Environment-Based Occupational Therapy

Participants will receive a multisensory environment-based occupational therapy intervention designed to expose them to structured sensory experiences. The intervention will last 4 weeks, delivered twice per week, for a total of 8 sessions, each lasting approximately 30 minutes. Sessions will be supportive and exploratory rather than directive.

Before the intervention, each participant's sensory preferences, personal history, and cognitive status will be assessed to individualize the session content. Each session will follow a three-part structure consisting of preparation, main activity, and closing. During the main activity, the therapist will accompany the participant, facilitate engagement, and provide graded sensory options.

The intervention will incorporate visual, auditory, tactile, proprioceptive, vestibular, olfactory, and taste stimuli. Examples include colored lighting, projected images, music, vibration tools, textured materials, movement-based activities, familiar scents

Intervention Type BEHAVIORAL

Occupational therapy

The control group will not participate in any multisensory environment-based interventions. Instead, they will receive a directive occupational therapy program focused on cognitive stimulation and promoting independence in daily living activities. The intervention will last 4 weeks, with two sessions per week, totaling 8 sessions, each approximately 30 minutes.

These sessions will not include purposeful multisensory experiences and will follow a structured, cognitively oriented approach tailored to the participant's abilities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Age 65 years or older

Clinical diagnosis of Alzheimer-type dementia according to DSM-5 criteria

Moderate stage dementia:

Global Deterioration Scale Stage 5

Mini-Mental State Examination score between 10 and 18

Living at home with a primary caregiver

Presence of a primary caregiver who can accompany the participant during therapy sessions

Basic literacy level (ability to read and write at a minimal functional level)

Application to or referral from the Occupational Therapy Departments of Çankırı Karatekin University or Hacettepe University

Exclusion Criteria

Presence of additional chronic, neurological, or sensory problems that impair communication

e.g., uncorrected visual impairment

e.g., uncorrected hearing impairment

Prior receipt of any non-pharmacological therapy specifically targeting dementia

Any medical or psychiatric condition that may interfere with participation or assessments
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Medine Nur Özata Değerli

Research Assistant, Occupational Therapist, PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe Universitesi

Altındağ, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Ravn MB, Klingberg T, Petersen KS. The Adult Sensory Profile in Care Homes Targeting People Diagnosed with Dementia: A Qualitative Study from the Care Provider Perspective. Rehabil Res Pract. 2018 Aug 5;2018:5091643. doi: 10.1155/2018/5091643. eCollection 2018.

Reference Type RESULT
PMID: 30155306 (View on PubMed)

Berthiaume, K., Craig, B., & Rayford, B. S. (2024). The collaboration between occupational therapy and psychology in treating adolescents in a psychiatric residential treatment facility. Multisensory immersion room as a treatment intervention. Occupational Therapy in Mental Health, 40(2), 123-137.

Reference Type RESULT

Bennett S, Laver K, Voigt-Radloff S, Letts L, Clemson L, Graff M, Wiseman J, Gitlin L. Occupational therapy for people with dementia and their family carers provided at home: a systematic review and meta-analysis. BMJ Open. 2019 Nov 11;9(11):e026308. doi: 10.1136/bmjopen-2018-026308.

Reference Type RESULT
PMID: 31719067 (View on PubMed)

Baker R, Holloway J, Holtkamp CC, Larsson A, Hartman LC, Pearce R, Scherman B, Johansson S, Thomas PW, Wareing LA, Owens M. Effects of multi-sensory stimulation for people with dementia. J Adv Nurs. 2003 Sep;43(5):465-77. doi: 10.1046/j.1365-2648.2003.02744.x.

Reference Type RESULT
PMID: 12919265 (View on PubMed)

Baker R, Bell S, Baker E, Gibson S, Holloway J, Pearce R, Dowling Z, Thomas P, Assey J, Wareing LA. A randomized controlled trial of the effects of multi-sensory stimulation (MSS) for people with dementia. Br J Clin Psychol. 2001 Mar;40(1):81-96. doi: 10.1348/014466501163508.

Reference Type RESULT
PMID: 11317951 (View on PubMed)

Ayres, A. J. (1972). Sensory integration and learning disorders. (No Title).

Reference Type RESULT

Akça Kalem Ş, H. H., Cummings JL, Gürvit H. (2005). Validation study of the Turkish translation of the Neuropsychiatric Inventory. 21st International Conference of Alzheimer's Disease International, İstanbul, Turkey.

Reference Type RESULT

Other Identifiers

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9337fecbc0f54b90

Identifier Type: -

Identifier Source: org_study_id

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