Mindfulness-Enhanced Cognitive-Motor Dual-Task Training Using Balance and Isokinetic Systems for Parkinson's Disease With Mild Cognitive Impairment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
The goal of this clinical trial is to learn if Mindfulness-Enhanced Dual-Task Training work to treat PD-MCI in adults. The main questions it aims to answer are:
Does Mindfulness-Enhanced Dual-Task Training improve the cognitive or motor function of participants? Can the combination of Dual-Task Training and Mindfulness achieve better effects?
Researchers will compare 3 groups (Dual-Task Training + Mindfulness, Dual-Task Training, and conventional motor task training) to see if Dual-Task Training and Mindfulness works to treat PD-MCI.
Participants will:
Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Between 55 and 75 years.
- •Disease Diagnosis: Clinically diagnosed with Idiopathic Parkinson's Disease (PD) according to the UK Parkinson's Disease Society Brain Bank Criteria.
- •Disease Stage: Hoehn & Yahr (H&Y) stages 1 to 2.
- •Cognitive Function: Montreal Cognitive Assessment (MoCA) score between 23 and 26, indicating mild cognitive impairment (MCI).
- •Medication Stability: Stable doses of antiparkinsonian medications for at least 4 weeks prior to screening.
- •Subjective Cognitive Complaints: Self-reported or informant-reported cognitive decline persisting for at least 6 months.
- •Ambulatory Ability: Able to walk independently, with or without assistive devices.
- •Sensory Abilities: Adequate vision and hearing to comply with study procedures.
- •Informed Consent: Willingness to provide written informed consent and comply with study requirements.
排除标准
- •Other Neurological Disorders: Presence of other neurological conditions that could affect cognitive function, such as Alzheimer's disease, stroke, or brain tumors.
- •Psychiatric Conditions: Severe psychiatric disorders, including major depressive disorder or schizophrenia.
- •Substance Abuse: Recent history of drug or alcohol abuse.
- •Serious Medical Conditions: Uncontrolled hypertension, diabetes, heart disease, or other conditions that could interfere with study participation or outcomes.
- •Severe Cognitive Impairment: Diagnosis of Parkinson's Disease Dementia (PDD).
- •Other Factors Affecting Cognition: Recent head trauma, uncontrolled thyroid dysfunction, vitamin B12 deficiency, or other conditions known to affect cognitive function.
- •Deep Brain Stimulation (DBS): History of DBS treatment. Participation in Other Clinical Trials: Participation in another clinical trial that could interfere with this study within the last 3 months.
研究组 & 干预措施
MDT group
Mindfulness-enhanced Dual-task Training
干预措施: Cognitive-Motor Dual-Task Training (Device)
MDT group
Mindfulness-enhanced Dual-task Training
干预措施: Mindfulness Training (Other)
DT group
Dual-task Training
干预措施: Cognitive-Motor Dual-Task Training (Device)
DT group
Dual-task Training
干预措施: Quiet Rest (Other)
ST group
Single-task Training
干预措施: Single-task Training (Device)
ST group
Single-task Training
干预措施: Quiet Rest (Other)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: From enrollment to the end of treatment at 4 weeks
The Montreal Cognitive Assessment (MoCA) is a widely used neuropsychological tool for detecting mild cognitive impairment (MCI). It assesses multiple cognitive domains, including attention, executive function, memory, language, visuospatial ability, abstraction, calculation, and orientation. The total score is 30 points, with higher scores indicating better cognitive function.
次要结局
未报告次要终点
研究者
Jingzhi Zhang
technician in charge
Nanjing Mingzhou Rehabilitation Hospital