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Набор скоро начнётся NCT07086040

Effects of RAS in SZ

Без фазы С лечением Schizophrenia and Schizoaffective Disorder

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: RAS incorporated in upper-limb movement training, Upper-limb movement training.
Кому может быть актуально
Состояния в реестре: Schizophrenia and Schizoaffective Disorder. Базовые параметры: 18 лет — 60 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
Тайвань
Следующий шаг
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Официальное название

Effects of Rhythmic Auditory Stimulation Therapy on Upper-Limb Movements, Function, and Quality of Life in Patients With Schizophrenia: Randomized Controlled Trials

Обзор

The two main groups of medicated patients with schizophrenia (SZ) are those receiving second-generation antipsychotics and those receiving first-generation antipsychotics. The purpose of this research project is to target each patient group to examine effects of rhythmic auditory stimulation (RAS) on upper-limb movements in medicated SZ patients in a 6-month follow-up period. The main questions of this project are: 1. Does RAS reduce severity of upper-limb bradykinesia (slow movements) and dyskinesia (repetitive and involuntary movements) after intervention, at 3-month follow-up and 6-month follow-up in SZ patients receiving second-generation antipsychotics? and 2. Does RAS reduce severity of upper-limb bradykinesia and dyskinesia after intervention, at 3-month follow-up and 6-month follow-up in SZ patients receiving first-generation antipsychotics? Researchers will compare upper-limb movement training with the aid of RAS to upper-limb movement training without the aid of RAS to see if RAS works to improve upper-limb movements in SZ patients. Participants will: 1. Undergo an interview and movement tests and fill out questionnaires before and after the movement training program and at 3-month follow-up and 6-month follow-up; and 2. Receive movement training for 40 minutes per session for a total of 21 sessions.

Вмешательства

  • Поведенческое RAS incorporated in upper-limb movement training
    RAS will be metronome beat sound with different tempi and will be incorporated in upper-limb movement training, which will last for 40 minutes per session for a total of 21 sessions.
  • Поведенческое Upper-limb movement training
    Upper-limb movement training will last for 40 minutes per session for a total of 21 sessions.

Первичные конечные точки

  • Purdue pegboard test [Срок оценки: Up to 1 week right before the 1st session of the intervention]
  • Purdue pegboard test [Срок оценки: Up to 1 week right after the last session of the intervention]
  • Purdue pegboard test [Срок оценки: After three months following the last session of the intervention]
  • Purdue pegboard test [Срок оценки: After six months following the last session of the intervention]
  • Box and Block Test [Срок оценки: Up to 1 week right before the 1st session of the intervention]
  • Box and Block Test [Срок оценки: Up to 1 week right after the last session of the intervention]
  • Box and Block Test [Срок оценки: After three months following the last session of the intervention]
  • Box and Block Test [Срок оценки: After six months following the last session of the intervention]
  • Extrapyramidal Symptom Rating Scale [Срок оценки: Up to 1 week right before the 1st session of the intervention]
  • Extrapyramidal Symptom Rating Scale [Срок оценки: Up to 1 week right after the last session of the intervention]
Вторичные конечные точки (12)
  • Jebsen-Taylor Hand Function Test [Срок оценки: Up to 1 week right before the 1st session of the intervention]
  • Jebsen-Taylor Hand Function Test [Срок оценки: Up to 1 week right after the last session of the intervention]
  • Jebsen-Taylor Hand Function Test [Срок оценки: After three months following the last session of the intervention]
  • Jebsen-Taylor Hand Function Test [Срок оценки: After six months following the last session of the intervention]
  • Averaged weekly working hours [Срок оценки: Up to 1 week right before the 1st session of the intervention]
  • Averaged weekly working hours [Срок оценки: Up to 1 week right after the last session of the intervention]
  • Averaged weekly working hours [Срок оценки: After three months following the last session of the intervention]
  • Averaged weekly working hours [Срок оценки: After six months following the last session of the intervention]
  • The short version of the World Health Organization Quality of Life questionnaire [Срок оценки: Up to 1 week right before the 1st session of the intervention]
  • The short version of the World Health Organization Quality of Life questionnaire [Срок оценки: Up to 1 week right after the last session of the intervention]
  • The short version of the World Health Organization Quality of Life questionnaire [Срок оценки: After three months following the last session of the intervention]
  • The short version of the World Health Organization Quality of Life questionnaire [Срок оценки: After six months following the last session of the intervention]

Критерии участия

\[For SZ patients\]

Критерии включения

  • A diagnosis of schizophrenia or schizoaffective disorder
  • Between 18 to 60 years old
  • Keeping the same antipsychotics and the same dosage at least 4 weeks right before joining the study
  • A Edinburgh Handedness Inventory score of > 60
  • A Montreal Cognitive Assessment score of ≥ 24

Критерии исключения

  • Substance abuse or drug abuse
  • Neurological diseases or medical conditions that affect upper-limb movements and hearing
  • Other psychiatric diagnoses in addition to a diagnosis of schizophrenia or schizoaffective disorder

\[For healthy participants\]

Критерии включения

  • Between 18 to 60 years old
  • A Edinburgh Handedness Inventory score of > 60
  • A Montreal Cognitive Assessment score of ≥ 24

Критерии исключения

  • Substance abuse or drug abuse
  • Neurological diseases or medical conditions that affect upper-limb movements and hearing
  • Psychiatric diagnoses
  • Taking psychotropic medications
  • Presence of first-degree relatives or siblings with diagnoses of psychiatric diseases.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • National Taipei University of Nursing and Health Sciences — Taipei

Идентификаторы

NCT: NCT07086040 · RAS in SZ

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗