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Набор по приглашению NCT07279103

Multisensory Environment-Based Occupational Therapy for Alzheimer's Patients

Без фазы С лечением Alzheimer s Disease Occupational Therapy Rehabilitation Caregiver Burnout

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Multisensory Environment-Based Occupational Therapy, Occupational therapy.
Кому может быть актуально
Состояния в реестре: Alzheimer s Disease, Occupational Therapy, Rehabilitation, Caregiver Burnout. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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 eight 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.

Подробное описание

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 an eight-week period, consisting of two 45-minute sessions per week conducted in a controlled multisensory therapy room. The control group will receive standard occupational therapy intervention.

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.

Вмешательства

  • Поведенческое 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 8 weeks, delivered twice per week, for a total of 16 sessions, each lasting approximately 45 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 c
  • Поведенческое 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 8 weeks, with two sessions per week, totaling 16 sessions, each approximately 45 minutes. These sessions will not include purposeful multisensory experiences and will follow a structured, cognitively oriented approach tailor

Первичные конечные точки

  • Cognitive Status [Срок оценки: 8 week]
  • Sensory Processing [Срок оценки: 8 week]
  • Behavioral and Psycological symptoms [Срок оценки: 8 week]
  • Caregiver burden [Срок оценки: 8 week]

Критерии участия

Критерии включения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Hacettepe Universitesi — Altındağ

Публикации

  • 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
  • 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. PMID 31719067
  • 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
  • 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
  • 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.

Идентификаторы

NCT: NCT07279103 · 9337fecbc0f54b90

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗