Multisensory Environment-Based Occupational Therapy for Alzheimer's Patients

NCT07279103 | Enrolling By Invitation

• 1 other identifier: 9337fecbc0f54b90
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Alzheimer's disease; dementia; occupational therapy; multisensory environment; sensory processing; cognitive function; behavioral and psychological symptoms; non-pharmacological intervention; caregiver burden

Outcome Measures

Primary Outcomes (4)

• Cognitive Status

  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

  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

  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

  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

Study Arms (2)

Multisensory Environment-Based Occupational Therapy

EXPERIMENTAL

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

Behavioral: Multisensory Environment-Based Occupational Therapy

Occupational therapy

EXPERIMENTAL

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

Behavioral: Occupational therapy

Interventions

Multisensory Environment-Based Occupational Therapy 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

Multisensory Environment-Based Occupational Therapy

Occupational therapy 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.

Occupational therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe Universitesi

Altındağ, Ankara, 0600, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 30155306 RESULT

• 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.

  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.

  PMID: 31719067 RESULT

• 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.

  PMID: 12919265 RESULT

• 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.

  PMID: 11317951 RESULT

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

  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.

  RESULT

MeSH Terms

Conditions

Caregiver Burden; Behavior; Alzheimer Disease; Dementia

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Occupational Therapist, PhD Candidate

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 12, 2025
• Study Start: May 10, 2025
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)