Investigation of the Effects of Dual-Task Balance and Gait Training Combined With Cognitive Training in Parkinson's Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change from Baseline in Static Standing Balance Parameters at 12 Training Sessions
研究概览
简要总结
The aim of the study is to examine the effects of a structured, cognitive dimension-specific cognitive training combined with dual-task balance and gait training on balance, gait, and cognition in individuals with Parkinson's disease.
详细描述
Parkinson's disease (PD) is the most common movement disorder and the second most prevalent neurodegenerative disease after Alzheimer's disease. In addition to cardinal motor symptoms such as bradykinesia, rigidity, and resting tremor, PD is associated with a wide spectrum of non-motor symptoms that substantially increase overall disease burden. Among these, cognitive impairment is particularly significant, occurring up to six times more frequently in individuals with PD compared to the healthy population.
Although research on cognition in PD has increased over the past two decades, knowledge and treatment strategies for cognitive deficits remain limited compared to those addressing motor symptoms. Since no effective treatment currently exists to prevent or delay cognitive decline in PD, investigations into cognitive interventions are gaining increasing importance for understanding and managing this disabling aspect of the disease, which may emerge at all stages.
One promising intervention is RehaCom, a computer-based program that provides personalized cognitive training modules tailored to individual needs. Previous studies have demonstrated that RehaCom improves cognitive performance, enhances quality of life, and optimizes function in impaired domains. By prioritizing learning principles and offering individualized training for specific cognitive dimensions, RehaCom has also been shown to promote neural plasticity in patients with PD.
Motor learning literature emphasizes that not only training intensity but also conditions resembling real-life scenarios are critical for effective rehabilitation. Daily activities often require walking and maintaining balance while simultaneously performing additional tasks, such as speaking (cognitive dual-task) or carrying an object (motor dual-task). Dual-task training, which integrates motor training with either a cognitive or an additional motor task, is a comprehensive approach supported by strong evidence. Compared to single-task practice, dual-task training enhances motor learning, yields greater functional gains, and facilitates transfer of these improvements to activities of daily living.
Considering the deficiencies in cognition as a reason for the progressive and irreversible nature of the pathogenesis of PD, the present study hypothesizes that providing structured cognitive skills training will be more effective in improving both motor and cognitive functions. However, a review of the literature indicates that studies in this area remain limited. Therefore, the present study aims to implement and evaluate a rehabilitation program combining cognitive training with dual-task-focused balance and gait exercises in individuals with PD.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with idiopathic Parkinson's disease by a neurologist.
- •Evaluated between Stage 1-3 according to the Hoehn and Yahr Staging Scale.
- •Aged 40 years or older.
- •Agreed to participate in the study after being given sufficient information.
排除标准
- •Patients with a Montreal Cognitive Assessment score of 20 and below.
- •Patients with cardiovascular, vestibular, musculoskeletal or additional neurological disease.
研究组 & 干预措施
Cognitive Training Combined with Dual-Task Training Group (DUAL-COG)
The intervention will start with core stability training, followed by dual-task balance and gait training. After completion of the dual-task training phase, participants will undergo structured cognitive training.
干预措施: Dual-Task Balance and Gait Training (Other)
Cognitive Training Combined with Dual-Task Training Group (DUAL-COG)
The intervention will start with core stability training, followed by dual-task balance and gait training. After completion of the dual-task training phase, participants will undergo structured cognitive training.
干预措施: Core Stability Training (Other)
Cognitive Training Combined with Dual-Task Training Group (DUAL-COG)
The intervention will start with core stability training, followed by dual-task balance and gait training. After completion of the dual-task training phase, participants will undergo structured cognitive training.
干预措施: Cognitive Training (Other)
Dual-Task Training Group (DUAL)
The intervention will start with core stability training, followed by dual-task balance and gait training.
干预措施: Core Stability Training (Other)
Dual-Task Training Group (DUAL)
The intervention will start with core stability training, followed by dual-task balance and gait training.
干预措施: Dual-Task Balance and Gait Training (Other)
结局指标
主要结局
Change from Baseline in Static Standing Balance Parameters at 12 Training Sessions
时间窗: From enrollment to the end of the 6-Week training program
The static standing balance of participants will be assessed using the Huber 360° Evolution System (LPG Systems, Valence, France). The following measurements will be performed with this device: Postural Stability Test: Postural stability will be evaluated in parallel feet (eyes open/closed) and single-leg positions. Each test will be repeated three times, with a 10-second rest interval between repetitions. The displacement area (mm²), and path length (mm) of the center of pressure will be recorded. Additionally, during the test, the displacement of the center of pressure per unit time will be recorded as velocity (mm/s).
Change from Baseline in Dynamic Standing Balance Parameters at 12 Training Sessions
时间窗: From enrollment to the end of the 6-Week training program
The dynamic standing balance of participants will be assessed using the Huber 360° Evolution System (LPG Systems, Valence, France). The following measurements will be performed with this device: Limits of Stability Test: During the test, participants will be instructed to shift their weight toward eight different directions. Each test will be repeated three times, with a 10-second rest interval between repetitions. Outcome measures will include the displacement of the center of pressure in each direction (mm) and the sway area (mm²) resulting from the displacement of the center of pressure across all directions.
Change from Baseline in Spatial Gait Analysis Parameters at 12 Training Sessions
时间窗: From enrollment to the end of the 6-Week training program
The C-Mill VR+ system (Motek Medical, Amsterdam, The Netherlands) will be used for the evaluation. The analysis will include the recording of step length (mm), step width (mm) and stride length (mm).
Change from Baseline in Temporal Gait Analysis Parameters at 12 Training Sessions
时间窗: From enrollment to the end of the 6-Week training program
The C-Mill VR+ system (Motek Medical, Amsterdam, The Netherlands) will be used for the evaluation. The analysis will include the recording of stance phase duration (ms), swing phase duration (ms), and double support phase duration (ms).
Change from Baseline in Walking Distance Parameter at 12 Training Sessions
时间窗: From enrollment to the end of the 6-Week training program
The C-Mill VR+ system (Motek Medical, Amsterdam, The Netherlands) will be used for the evaluation. The analysis will include the recording of walking distance (m) as a functional performance outcome.
Change from Baseline in Gait Speed at 12 Training Sessions
时间窗: From enrollment to the end of the 6-Week training program
The C-Mill VR+ system (Motek Medical, Amsterdam, The Netherlands) will be used in the evaluation. The analysis will include recording the displacement of the individual per unit time on the running belt as gait speed (m/s).
Change from Baseline in Montreal Cognitive Assessment (MoCA) Score at 12 Training Sessions
时间窗: From enrollment to the end of the 6-Week training program
Montreal Cognitive Assessment (MoCA), which provides a general cognitive screening in different cognitive functions such as attention, concentration, executive functions, memory, language, visual structuring skills, abstract thought, calculation and orientation, will be used in the general evaluation of cognition. MoCA is an effective scale especially in the evaluation of mild cognitive impairments in Parkinson's disease (PD). The cut-off score range of MoCA has been shown to be 18-26 points in individuals with PD who has mild cognitive impairment. The administration of MoCA takes approximately 10 minutes. The highest total score that can be obtained from the test is 30. Accordingly, a score of 21 points and above is considered normal.
Change in Domain-Specific Cognitive Assessment Parameters from Baseline after 12 Training Sessions
时间窗: From enrollment to the end of the 6-Week training program
In the comprehensive evaluation of cognition, specific evaluation will be made for the sub-domains of cognition which are "Attention", "Memory" and "Executive Functions" will be made using the screening modules of the RehaCom software. Before each evaluation, a practice mode will be applied in which the patient is informed about the things to be careful about during the evaluation, the expected task and the purpose of the evaluation. In all screening results, the z-values, mean of reaction time (ms), median of reaction time (ms), standard deviation of reaction time (ms) and correct, incorrect, error and skip numbers in the tests will be recorded as standardized data compared with the data of at least 200 age and gender matched healthy individuals in RehaCom's database.
次要结局
- Change from Baseline in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3: Motor Examination Scores at 12 Training Sessions(From enrollment to the end of the 6-Week training program)
- Change from Baseline in Activities-Specific Balance Confidence (ABC) Scale Scores at 12 Training Sessions(From enrollment to the end of the 6-Week training program)
- Change from Baseline in Percentile of Evaluation of Dual-Task Effect at 12 Training Sessions(From enrollment to the end of the 6-Week training program)
研究者
Arzu Güçlü Gündüz
Professor, PhD, PT
Gazi University