Assessment of Methods Used in Evaluating Balance Rehabilitation in Parkinson's Patients: Determination of Responsiveness and Minimal Clinically Important Difference Values
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Biodex
研究概览
简要总结
Balance rehabilitation holds an important place in the treatment of Parkinson's patients. Before and after treatment, patients are evaluated using various measurement methods. In calculations of changes post-treatment, although statistically significant changes are detected, clinical differences are often not observed. Jaeschke et al. developed the concept of minimal clinically important difference (MCID) to address this. They have worked on methods to determine the level of MCID. These measurements help clinicians understand which results can be interpreted as clinically meaningful for the patient.
Responsiveness refers to how sensitive a measurement tool is to changes, whereas MCID focuses on determining whether these changes are clinically significant. Both concepts are crucial for understanding and interpreting the performance of measurement tools.
Identifying which patients have a high risk of balance problems and falls, and screening those at risk, is important for making treatment decisions. Determining which change values are clinically significant (MCID) and identifying which tests are more sensitive in detecting changes (responsiveness) are essential in monitoring patients.
详细描述
Parkinson's disease (PD) is a chronic progressive neurodegenerative disease characterized by the degeneration or loss of dopaminergic neurons in the nigrostriatal and other neuronal systems, along with the formation of Lewy bodies in dopaminergic neurons, and it manifests with both motor and non-motor symptoms and findings. It is the second most common neurodegenerative disease after Alzheimer's disease. The average onset age is between 60-80 years. It is more commonly seen in men and the white race. In Turkey, the prevalence has been reported as 111/100,000. In societies where the average lifespan is increasing, the frequency of PD and the associated economic burden are also expected to increase.
The etiology of Parkinson's disease includes environmental, genetic, and aging-related processes. These factors trigger mechanisms leading to neuron degeneration and loss, causing PD.
The clinical presentation of Parkinson's disease consists of motor and non-motor symptoms and findings. The main motor symptoms are bradykinesia, rigidity, postural instability, and resting tremor. Other observed findings include akinesia, freezing phenomenon, postural and gait disorders, reciprocal movement disorder, masked facial expression, impaired orofacial functions and speech, swallowing disorder, respiratory function impairment, loss of hand dexterity, and coordination. Cognitive impairments, depression, sleep disorders, autonomic dysfunction, loss of smell, fatigue, and sialorrhea are among the non-motor symptoms.
Patients with primary motor findings and accompanying symptoms are evaluated using the Parkinson's Disease United Kingdom Brain Bank Criteria and the National Institute of Neurological Disorders and Stroke (NINDS) diagnostic criteria. A definitive diagnosis is made by pathologically demonstrating Lewy bodies in a biopsy. The Hoehn-Yahr Scale is frequently used to determine the severity of the disease.
The treatment of Parkinson's disease includes medical treatment, surgical treatment, and rehabilitation. Rehabilitation plays an important role at all stages of PD. In the early stages, it helps maintain well-being and improve general conditioning; in the later stages, it is crucial for coping with motor and non-motor complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease
- •Aged between 50-80 years
- •Modified Hoehn and Yahr stage 1.5 - 3
- •On stable medical treatment for the last 3 months
- •Mini-Mental State Examination score > 23
- •Approval of the informed consent form
排除标准
- •Age below 50 or above 80 years
- •Musculoskeletal disorders, severe osteoarthritis, peripheral neuropathy, or history of -previous lower extremity joint replacement
- •Cardiovascular disease, especially uncontrolled hypertension exceeding 180/110 mm Hg at rest within the last four weeks, or recent myocardial infarction
- •Orthostatic hypotension
- •Body weight exceeding 100 kg
- •Respiratory system disease
- •Presence of severe dyskinesia, visual impairment, and uncontrolled on-off fluctuations
结局指标
主要结局
Biodex
时间窗: One Month
Determination of the minimal clinical important change values of balance scores (fall risk test) determined by the Biodex balance system in Parkinson's disease
次要结局
- timed up and go test(One Month)
- International Fall Activity Scale(One Month)