- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07279103
Multisensory Environment-Based Occupational Therapy for Alzheimer's Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ankara
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Altındağ, Ankara, Turkey (Türkiye), 0600
- Hacettepe Universitesi
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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 communicatione.g., uncorrected visual impairment., 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multisensory Environment-Based Occupational Therapy
Participants in this arm will receive an exploratory, multisensory environment-based occupational therapy program.
|
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 |
|
Experimental: Occupational therapy
Participants in this arm will receive a structured, directive occupational therapy program focusing on cognitive stimulation and daily living activities
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Status
Time Frame: 8 week
|
The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric Version is a cognitive assessment battery used by occupational therapists to identify cognitive impairments that affect daily functioning and quality of life in older adults.
The tool includes a structured assessment kit, a manual, and scoring guidelines.
It evaluates six cognitive domains-orientation, perception, praxis, visuomotor organization, thinking operations, and memory-through 23 subtests.
The assessment kit contains various materials such as colored blocks, tangrams, grooming items, sequencing cards, picture booklets, categorization cards, a pegboard, and a clock-drawing sheet.
The manual provides instructions on administering the subtests and scoring each item.
Scores range from 1 to 4 depending on performance.
Therapists conduct the assessment using the standardized materials and record the results on the scoring form.
It is a commercially available assessment and is accessible in
|
8 week
|
|
Sensory Processing
Time Frame: 8 week
|
Adult Sensory Profile (ASP): The Adult Sensory Profile was developed to evaluate sensory response patterns related to sensory systems in adults. Based on Ayres' Sensory Integration Theory, the profile aims to assess behavioral response patterns that indicate sensory processing difficulties across specific sensory systems, including over-responsivity, under-responsivity, and sensory seeking. Over-responsivity refers to heightened reactions to ordinary stimuli that typically do not bother others; under-responsivity refers to a lack of awareness of stimuli that most people would notice; and sensory seeking refers to behaviors characterized by actively pursuing sensory input with higher intensity or frequency than usual. The ASP consists of 11 factors and 48 items, scored on a 5-point Likert scale (1: never, 2: rarely, 3: sometimes, 4: often, 5: always). The Turkish validity and reliability study of the scale has also been conducted. |
8 week
|
|
Behavioral and Psycological symptoms
Time Frame: 8 week
|
Neuropsychiatric Inventory: This inventory will be used to assess behavioral and psychological symptoms associated with dementia. Developed in 1994, it evaluates delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, abnormal motor behaviors, sleep/nighttime problems, and changes in appetite/eating habits. Each subdomain is rated based on frequency (0-4), severity (0-3), and caregiver distress (0-5). Subdomain scores are calculated by multiplying frequency and severity. The total inventory score is obtained by summing all subdomain scores. The minimum possible score is 0 and the maximum is 144. Scores between 0-20 indicate mild symptoms, 21-50 indicate moderate symptoms, and scores above 50 indicate severe behavioral and psychological symptoms related to dementia. The Turkish validity and reliability study of the inventory reported a Cronbach's alpha value of 0.79. |
8 week
|
|
Caregiver burden
Time Frame: 8 week
|
Caregiver Burden Inventory: This inventory was developed to measure the impact of caregiving. It consists of 24 items rated on a 0-4 Likert scale and includes five subscales: (a) time-dependence burden, (b) developmental burden, (c) physical burden, (d) social burden, and (e) emotional burden. The total score ranges from 0 to 100, with higher scores indicating a greater level of caregiver burden. The Turkish validity and reliability study reported high internal consistency, with Cronbach's alpha values of 0.94 for the total scale and similarly high reliability coefficients for each subscale. |
8 week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Ayres, A. J. (1972). Sensory integration and learning disorders. (No Title).
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Neurocognitive Disorders
- Tauopathies
- Neurodegenerative Diseases
- Stress, Psychological
- Caregiver Burden
- Alzheimer Disease
- Dementia
- Behavior
- Therapeutics
- Patient Care
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Occupational Therapy
Other Study ID Numbers
- 9337fecbc0f54b90
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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