Integrated Motor-Cognitive Training in Parkinson's Disease: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility Outcomes: Eligibility Rate
研究概览
简要总结
Parkinson's disease is a progressive neurodegenerative condition characterized by both motor symptoms (such as bradykinesia, rigidity, tremor, and postural instability) and non-motor symptoms, including cognitive impairments (affecting working memory, executive functions, and attention). Combined interventions that target both domains simultaneously or consecutively have shown potential to produce superior benefits compared to isolated motor or cognitive training.
The purpose of this study is to evaluate the feasibility, adherence, and preliminary clinical results of efficacy of an integrated and combined motor-cognitive rehabilitation training in patients diagnosed with Parkinson's disease.
This feasibility study will enroll 12 participants with Parkinson's disease. All participants will undergo a comprehensive 10-session integrated rehabilitation program combining digital cognitive individual stimulation and group functional motor training. The primary focus is to assess acceptability, safety, and adherence to this combined approach, while secondary outcomes will observe changes in relevant cognitive and motor clinical variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease
- •Presence of motor symptoms attributable to Parkinson's disease
- •Availability to participate in both treatments (cognitive and motor)
- •Severity of symptoms compatible with participation in group physical therapy
- •Absence of other medical conditions that could interfere with treatment delivery
- •Montreal Cognitive Assessment (MoCA) score >= 18
- •Consent to participate in group-based motor training
- •Absence of falls in the 3 months prior to baseline evaluation
排除标准
- •Concomitant major neurological or psychiatric disorders
- •Severe cardio-pulmonary, renal, or hepatic diseases
- •Changes in baseline pharmacological therapy within 3 months prior to enrollment
研究组 & 干预措施
Combined Motor-Cognitive Training Group
Participants will receive a 10-session integrated rehabilitation program combining individual digital cognitive stimulation and group functional motor training
干预措施: Combined group motor training and individual digital cognitive stimulation (Behavioral)
结局指标
主要结局
Feasibility Outcomes: Eligibility Rate
时间窗: Baseline
Calculated as the ratio of eligible patients to the total number of screened patients.
Feasibility Outcomes: Recruitment Rate
时间窗: Baseline
Calculated as the ratio of recruited patients to total eligible patients.
Feasibility Outcomes: Monthly Recruitment Rate
时间窗: Baseline
Defined as the average number of participants enrolled per month.
Feasibility Outcomes: Drop-out Rate
时间窗: score changes after intervention (4 weeks, T1)
The percentage of participants who withdraw from the study.
Feasibility Outcomes: Adherence Rate
时间窗: score changes after intervention (4 weeks, T1)
The percentage of scheduled training sessions attended
Feasibility Outcomes: Longitudinal Retention Rate
时间窗: Post-intervention follow-up assessment (3 months after intervention completion)
The percentage of enrolled participants who complete all follow-up assessments
Feasibility Outcomes: Self-Reported Acceptability
时间窗: score changes after intervention (4 weeks, T1)
Participants will complete a questionnaire at the end of the intervention to evaluate their subjective experience, perceived benefits, and difficulties of the treatment. Items are rated on a 5-point Likert scale ranging from 1 ("low") to 5 ("extremely high"), with higher scores indicating a more positive evaluation or greater perceived benefit/difficulty.
Feasibility Outcomes: Adverse Events
时间窗: score changes after intervention (4 weeks, T1)
The incidence and severity of any adverse events (e.g., falls or excessive fatigue) recorded during the study.
Feasibility Outcomes: Motor Exercise Intensity
时间窗: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
The Borg Rating of Perceived Exertion (RPE) will be used to monitor and quantify physical and cognitive effort. Total score ranges from 6 to 20. Higher scores indicate greater perceived exertion
Feasibility Outcomes: Motor Exercise Exertion
时间窗: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
The Borg Intensity Scale-Exerciser (BIS-E) will be used to quantify exertion. Total score ranges from 0 to 30, higher scores indicate greater perceived balance effort, difficulty, and postural instability during circuit stations.
Feasibility Outcomes: Digital Cognitive Progression Index (NeuronUP Activity Score)
时间窗: Monitored during every training session (Up to 4 weeks, from Sessions 1 through 10)
Digital Cognitive Progression Index (NeuronUP Activity Score) will be used to quantifies session-by-session cognitive performance and adaptive difficulty progression across the 10 training sessions. The score is calculated using NeuronUP's standardized algorithm based on accuracy, total completed phases, and maximum difficulty reached, yielding a score from 0 to 100. Higher scores reflect greater task proficiency and successful progression to higher difficulty levels. This metric serves as an exploratory/feasibility measure of intra-intervention cognitive learning.
次要结局
- Motor Outcomes: Change in dynamic balance, mobility, and gait(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Motor Outcomes: Change in Gait speed(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Motor Outcomes: Change in Distance Walked(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Motor Outcomes: Change in Dynamic Balance(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Motor Outcomes: Change in Finger motor speed(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Cognitive Outcomes: Change in Global cognitive function(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Cognitive Outcomes: Change in Visual search and processing speed(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Cognitive Outcomes: Change in executive function, cognitive flexibility, and set-shifting.(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Cognitive Outcomes: Change in Information processing speed and attention(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Cognitive Outcomes: Decision-making processing speed and cognitive-motor control(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Cognitive Outcomes: Change in perceptive-motor speed(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Change in Quality of Life(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))
- Change in Fatigue(Baseline (T0), post-treatment (4 weeks, T1), and follow-up (T2, 3 months post-treatment))