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Идёт набор NCT07697664

Moving Yourself in Space and Time: MYSTIC

Без фазы С лечением Parkinson's Disease (PD) Alzheimer's Disease (AD) and Related Disorders Older Adults (60 - 85 Years Old)

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: Complex Rhythmic Movement Sequences (CRMS) Sessions.
Кому может быть актуально
Состояния в реестре: Parkinson's Disease (PD), Alzheimer's Disease (AD) and Related Disorders, Older Adults (60 - 85 Years Old). Базовые параметры: 18 лет — 79 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
США
Следующий шаг
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Официальное название

Moving Yourself in Space and Time Identifying Spatial and Temporal Components of Complex Rhythmic Movement Training for People With Parkinson's Disease and Cognitive Impairment

Обзор

This study is being done to answer the question: Do people with Parkinson's benefit from a new stepping therapy, and how do people with Parkinson's best learn new steps and rhythms set to music? Researchers will also compare individuals with Parkinson's Disease with people with Mild Cognitive Impairment, and with people with neither of these conditions. The purpose of this study is to identify principles of human-music interactions to establish underlying guiding theories for application to music-based rehabilitation for older populations with neurodegenerative disease, leading to more refined and targeted music-based rhythmic movement therapies.

Подробное описание

This study aims to analyze the effects of an innovative rehabilitation intervention comprising complex rhythmic movement sequence (CRMS) rehabilitation (aka, Spatiotemporal Activity Modification (STEAM)) training for adults. The central hypothesis is that the spatial and temporal components of CRMS are learned at slower rates in mild cognitive impairment (MCI) than in controls, and that CRMS-based rehabilitation strategies can improve cognitive and mobility status in MCI. Researchers hypothesize that people with cognitive impairment or Parkinson's disease (PD) will show reduced capacity and slower responses when modulating their movements to auditory cues encoded within complex musical-rhythmic patterns.

Musical rhythm, which includes the timing and pattern of sound in music, can be communicated through touch or via audible cues.

Objective 1: Evaluate the hypothesis that people with cognitive impairment or Parkinson's disease (PD) will show reduced capacity and slower responses when modulating their movements to auditory cues encoded within complex musical-rhythmic patterns.

Aim 1. Determine whether the temporal and spatial components of movement are learned at different timescales during human-music movement sequence learning.

Researchers will draw on research in music theory to develop a novel, task-specific set of musical patterns that map and facilitate learning of complex spatiotemporal rhythms during walking tasks. The research team will measure spatial, temporal, and kinematic variables during the physical human-music interaction and will alter combinations of spatial and temporal relationships within movements, in healthy younger (18-35 years), a subset of whom (n=10) are experienced dancers, and individuals (age older than 50 years), individuals with MCI, and individuals with PD. Researchers will analyze data from single-session time courses of learning rhythm, within-session changes, and short-term (24-hour) retention.

Hypothesis: Compared to healthy older adults and younger adults, older adults with MCI and older adults with PD will show (H1a) smaller magnitude and slower learning rates for spatial and temporal movement components, and (H1b) greater challenge with learning-coupled spatio-temporal (more complex) rhythmic movements versus spatial or temporal rhythmic movement components alone. Data from the subset of experienced dancers will help us establish biomechanical markers of expert performance.

Objective 2: Evaluate the preliminary effects, safety, acceptability, and tolerability of rhythmic movement training in healthy younger adults, healthy older adults, older adults with mild cognitive impairment, and older adults with Parkinson's disease.

Aim 2: Explore the thoughts, perceptions, and attitudes of people with MCI and their caregivers, regarding their relationship to music, to dance, and a therapeutic program involving popular music, rhythm, and movement sequences designed for people with MCI.

Aim 2 Approach: Participants with MCI will be interviewed for their thoughts, perceptions, and attitudes regarding CRMS.

Aim 3: Evaluate the feasibility and preliminary effects of a 3-week daily (e.g., 3-5 times per week; 1.5-hour classes) program of varied rhythmic movement sequences performed to music for people with MCI and people with PD.

Researchers will also assess participants before and after the program for clinical, biomechanical, functional, and cognitive measures. Intensive programs have previously been shown to be feasible and effective for similar forms of training and will allow efficient collection of data as well as testing of a useful schedule of treatment.

Вмешательства

  • Другое Complex Rhythmic Movement Sequences (CRMS) Sessions
    Researchers will establish complex rhythmic movement sequences (CRMS) as an experimental paradigm to identify spatial and temporal components and learning time courses of complex rhythmic movement. Participants will dance with new partners every 15-20 minutes, a widely practiced method of the dance community to enhance learning. The class format is: 1. practicing previously learned steps 2. 25-minute warmup, partnering/rhythmic exercises 3. learning new steps 4. combining old and new steps 5.

Первичные конечные точки

  • Four-Square Step Test (FSST) [Срок оценки: Baseline and post-intervention (3 to 5 weeks)]
  • Gait Speed [Срок оценки: Baseline and post-intervention (3 to 5 weeks)]
  • Body Position Spatial Task (BPST) [Срок оценки: Baseline and post-intervention (3 to 5 weeks)]
  • 30-Second Sit-to-Stand test [Срок оценки: Baseline and post-intervention (3 to 5 weeks)]
  • 360 Turn Test (Steps) [Срок оценки: Baseline and post-intervention (3 to 5 weeks)]
  • 360 Turn Test (Time) [Срок оценки: Baseline and post-intervention (3 to 5 weeks)]
Вторичные конечные точки (3)
  • Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual) [Срок оценки: Baseline and post-intervention (3 to 5 weeks)]
  • Short Form 12-Quality of Life (SF12) [Срок оценки: Baseline and post-intervention (3 to 5 weeks)]
  • Activities-specific Balance Confidence Scale (ABC) [Срок оценки: Baseline and post-intervention (3 to 5 weeks)]

Критерии участия

Inclusion Criteria for Young adults and adults with normal cognition (NC):

  • 18 to 35 Years old
  • Montreal Cognitive Assessment (MoCA) score of 26 to 30

Inclusion Criteria for Older Adults:

  • 50 to 79 with or without MCI
  • 50 to 79 years old with Parkinson's disease (PD), who do NOT have impaired decision-making capacity
  • Participants who achieve less than 150 minutes moderate or 75 minutes vigorous aerobic activity per week (as per the US Department of Health and Human Services (HHS)),

Exclusion Criteria for all groups:

  • Acute medical illness requiring hospitalization;
  • Uncontrolled congestive heart failure;
  • History of stroke in the past three years;
  • Inability to perform study procedures;
  • Medical or physical conditions that would preclude participation (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal failure, history of angina with activity);
  • On medications that could adversely affect cognition, e.g., antipsychotics, opioids, stimulants, chemotherapy, and neurologic prescriptions to treat Multiple Sclerosis. When applicable, enrollment will be delayed until dosages are stable on e.g., Aricept, Namenda, anticholinesterase inhibitors, for at least 3 months
  • Psychotic disorders
  • Confounding neurologic conditions \[e.g., active central nervous system (CNS) opportunistic infections, seizure disorders, head injury with loss of consciousness >30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae\]
  • Substance Use Disorder, Major Depressive Disorder, and Generalized Anxiety Disorder within six months of evaluation.
  • Inability to provide informed consent

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Emory University, Executive Park, Wesley Woods — Atlanta

Идентификаторы

NCT: NCT07697664 · 2025P010753

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗