Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT07279103
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-12
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multisensory Environment-Based Occupational Therapy for Alzheimer's Patients
Sponsor:
Hacettepe University
Organization:
Study Overview
Official Title:
The Effect of Multisensory Environment-Based Occupational Therapy Intervention on Sensory Processing, Cognitive, Behavioral Symptoms and Caregiver Burden in Alzheimer's Patients: A Randomized Controlled Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: