Effects of Whole-Body Vibration at Different Frequencies on Balance, Gait, Cognitive Functions, and Dual-Task Performance in Patients With Parkinson's Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mini Balance Evaluation Systems Test (Mini-BESTest)
研究概览
简要总结
The aim of this study is to evaluate the effects of different frequencies of Whole Body Vibration (WBV) application on balance, gait, cognitive functions, and dual-task performance in patients with Parkinson's disease.
Study Hypotheses:
H0.1 - There is no effect of different frequencies of WBV application on balance performance in patients with Parkinson's disease.
H1.1 - There is an effect of different frequencies of WBV application on balance performance in patients with Parkinson's disease.
H0.2 - There is no effect of different frequencies of WBV application on gait performance in patients with Parkinson's disease.
H1.2 - There is an effect of different frequencies of WBV application on gait performance in patients with Parkinson's disease.
H0.3 - There is no effect of different frequencies of WBV application on cognitive functions in patients with Parkinson's disease.
H1.3 - There is an effect of different frequencies of WBV application on cognitive functions in patients with Parkinson's disease.
H0.4 - There is no effect of different frequencies of WBV application on dual-task performance in patients with Parkinson's disease.
H1.4 - There is an effect of different frequencies of WBV application on dual-task performance in patients with Parkinson's disease.
H0.5 - There is no effect of different frequencies of WBV application on reaction time in patients with Parkinson's disease.
H1.5 - There is an effect of different frequencies of WBV application on reaction time in patients with Parkinson's disease.
H0.6 - There is no significant difference between medium-frequency and low-frequency WBV in terms of balance performance in patients with Parkinson's disease.
H1.6 - There is a significant difference between medium-frequency and low-frequency WBV in terms of balance performance in patients with Parkinson's disease.
H0.7 - There is no significant difference between medium-frequency and low-frequency WBV in terms of gait performance in patients with Parkinson's disease.
H1.7 - There is a significant difference between medium-frequency and low-frequency WBV in terms of gait performance in patients with Parkinson's disease.
H0.8 - There is no significant difference between medium-frequency and low-frequency WBV in terms of cognitive functions in patients with Parkinson's disease.
H1.8 - There is a significant difference between medium-frequency and low-frequency WBV in terms of cognitive functions in patients with Parkinson's disease.
H0.9 - There is no significant difference between medium-frequency and low-frequency WBV in terms of dual-task performance in patients with Parkinson's disease.
H1.9 - There is a significant difference between medium-frequency and low-frequency WBV in terms of dual-task performance in patients with Parkinson's disease.
H0.10 - There is no significant difference between medium-frequency and low-frequency WBV in terms of reaction time in patients with Parkinson's disease.
H1.10 - There is a significant difference between medium-frequency and low-frequency WBV in terms of reaction time in patients with Parkinson's disease.
详细描述
Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's disease and affects approximately 10 million people worldwide. Each year, more than 60,000 new cases are diagnosed in the United States alone, and this number is reported to be increasing globally. With the aging population, the prevalence of Parkinson's disease is also rising; in particular, it is reported that the prevalence among individuals over 65 years of age ranges between 1 and 2 per 1,000 people. Therefore, Parkinson's disease represents a significant health and social care burden at both individual and societal levels.
Recent studies emphasize that Parkinson's disease is a multidimensional condition and that the changes occurring during its course play a key role in disease progression.
Balance impairment and postural control deficits are among the most common problems in Parkinson's disease. Research has shown that the risk of falls is significantly increased in this patient group, with approximately 60% of patients exhibiting a tendency to fall. Balance disorders not only threaten physical safety but also restrict individuals' independence and participation in activities of daily living. Therefore, balance is considered one of the primary targets for improvement in Parkinson's rehabilitation.
Gait disturbances are another prominent functional limitation in Parkinson's disease. Reduced walking speed, shortened step length, and irregular gait rhythm lead to significant limitations in daily living activities. Loss of gait performance reduces mobility and makes independent living more difficult. For this reason, gait is considered one of the most critical targets in physiotherapy and rehabilitation programs.
Cognitive impairments are also commonly observed in patients with Parkinson's disease. These impairments typically occur in the domains of attention, executive functions, and memory. Cognitive deficits reduce independence in daily activities, limit social participation, and decrease quality of life. In addition, cognitive impairments may negatively affect the sustainability of gains achieved through motor rehabilitation.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 30-80 years with a clinical diagnosis of Parkinson's disease. Hoehn and Yahr stages 1-
- •Stable medical treatment (no changes in medication for the past 4 weeks).
- •Willingness to participate and provision of written informed consent.
- •Score of 24 or higher on the Standardized Mini Mental State Examination (SMMSE).
排除标准
- •Advanced stage Parkinson's disease (Hoehn and Yahr stage >3) or presence of severe motor complications.
- •History of surgical interventions or other neurological/vestibular disorders that may affect balance and gait (E.G., stroke, epilepsy, peripheral neuropathy).
- •Presence of severe cardiovascular or respiratory conditions that may affect stability (E.G., heart failure, uncontrolled hypertension, advanced COPD).
- •Conditions contraindicating whole-body vibration (WBV) application (E.G., severe osteoporosis, active thrombosis).
- •Psychiatric disorders or major depression that may interfere with treatment participation.
- •Significant communication or language impairments affecting participation.
- •Withdrawal Criteria
- •Voluntary withdrawal from the study.
- •Development of health problems during the intervention that prevent completion of the study (E.G., unexpected acute illness or temporary medical condition).
- •Changes in medication or medical status during the study that may affect participation or performance.
- •Non-adherence to the protocol (attendance rate below 80% of sessions).
研究组 & 干预措施
Medium Frequency Whole Body Vibration (WBV) Group
Participants will receive a functional exercise based physiotherapy program in a hospital setting, conducted twice per week for 8 weeks. In addition, Whole Body Vibration (WBV) will be applied for 20 minutes per session at a medium frequency range (12-20 Hz).
干预措施: Functional Exercise Based Physiotherapy (Behavioral)
Low Frequency Whole Body Vibration (WBV) Group
Participants will receive a functional exercise based physiotherapy program in a hospital setting, conducted twice per week for 8 weeks. In addition, Whole Body Vibration (WBV) will be applied for 20 minutes per session at a low frequency range (3-10 Hz).
干预措施: Low-Frequency Whole-Body Vibration Therapy (Device)
Medium Frequency Whole Body Vibration (WBV) Group
Participants will receive a functional exercise based physiotherapy program in a hospital setting, conducted twice per week for 8 weeks. In addition, Whole Body Vibration (WBV) will be applied for 20 minutes per session at a medium frequency range (12-20 Hz).
干预措施: Medium-Frequency Whole-Body Vibration Therapy (Device)
Control Group
Participants, will receive a functional exercise based physiotherapy program in a hospital setting. The program will be supervised and conducted twice per week for 8 weeks.
干预措施: Functional Exercise Based Physiotherapy (Behavioral)
Low Frequency Whole Body Vibration (WBV) Group
Participants will receive a functional exercise based physiotherapy program in a hospital setting, conducted twice per week for 8 weeks. In addition, Whole Body Vibration (WBV) will be applied for 20 minutes per session at a low frequency range (3-10 Hz).
干预措施: Functional Exercise Based Physiotherapy (Behavioral)
结局指标
主要结局
Mini Balance Evaluation Systems Test (Mini-BESTest)
时间窗: Baseline and 8 weeks
Participants will be assessed while standing on a flat and firm surface. During the test, appropriate safety precautions will be taken if necessary to ensure participant safety. The assessment includes 4 subcomponents and 14 items: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each subcomponent represents different aspects of balance control and evaluates specific components of the postural control system. In each section of the assessment, participants will be asked to perform various functional tasks, and their performance will be observed during these tasks. The tasks include sit-to-stand and stand-to-sit transitions, standing balance, forward reach, backward stepping, standing with eyes closed, and turning while walking. Each item is scored on a 0-2 scale (0 = Severe İmpairment, 1 = Moderate İmpairment, 2 = Normal/No İmpairment), with a total score ranging from 0 to 28.
10 Meter Walk Test (10MWT)
时间窗: Baseline and 8 weeks
Participants will be assessed while standing on a flat, firm, and non-slip surface. Participants will be asked to walk a 14 meter walkway, with the central 10 meter section used for timing. Walking speed will be recorded over this 10 meter distance. The test will be performed under two conditions: comfortable walking speed and maximum walking speed, with two trials for each condition. Completion time will be measured using a stopwatch, and walking speed will be calculated and expressed as meters per second (m/s) based on the average of the trials.
次要结局
- Verbal Fluency Test(Baseline and 8 weeks)
- Forward-Backward Digit Span Test(Baseline and 8 weeks)
- Trail Making Test (TMT)(Baseline and 8 weeks)
- Stroop Color and Word Test(Baseline and 8 weeks)
- Dual-Task Gait Test(Baseline and 8 weeks)
- Dual-Task Timed Up and Go (TUG) Test(Baseline and 8 weeks)
- Ruler Drop Test(Baseline and 8 weeks)
研究者
Gülbin Ergin
Prof.Dr
Izmir Bakircay University