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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Sensory Processing
研究概览
简要总结
This study aims to examine 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. Non-pharmacological approaches to Alzheimer's disease 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 among 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 eight weeks, with two sessions per week. Outcome measures will include the Adult Sensory Processing Scale, Mini-Mental State Examination, Loewenstein Occupational Therapy Cognitive Assessment-Geriatric, Neuropsychiatric Inventory, and Caregiver Burden Inventory. The study is expected to contribute to the evidence base supporting sensory-based occupational therapy interventions in dementia care.
详细描述
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 group will receive a multisensory environment-based intervention in addition to standard occupational therapy for eight weeks. The control group will receive standard occupational therapy intervention.
Outcome measures will include the Adult Sensory Processing Scale 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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Multisensory Environment-Based Occupational Therapy
Participants in this arm will receive a multisensory environment-based occupational therapy intervention in addition to standard occupational therapy.
干预措施: Multisensory Environment-Based Occupational Therapy (Behavioral)
Occupational therapy
Participants in this arm will receive a structured, directive occupational therapy program focusing on cognitive stimulation and daily living activities
干预措施: Occupational therapy (Behavioral)
结局指标
主要结局
Sensory Processing
时间窗: 8 week
Adult Sensory Processing Scale 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 ASPS 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.
Cognitive Status
时间窗: 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
Behavioral and Psycological symptoms
时间窗: 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.
Caregiver burden
时间窗: 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.
次要结局
未报告次要终点
研究者
Medine Nur Özata Değerli
Research Assistant, Occupational Therapist, PhD Candidate
Hacettepe University