Rehabilitation Program to Improve Balance in Patients With Parkinson's Disease: Dual-Task Exercise - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- UPDRS (Unified Parkinson's Disease Rating Scale)
研究概览
简要总结
The goal of this clinical trial is to learn if a rehabilitative pathway based on dual-task exercise improves balance in patients with Parkinson's disease, compared to a traditional rehabilitation program. It will also investigate the reduction of fall risk, and improvement in autonomy and quality of life.
The main questions it aims to answer are:
- Does dual-task exercise improve balance more effectively than traditional rehabilitation in Parkinson's patients?
- Does dual-task exercise reduce the risk of falls?
- Does dual-task exercise improve patient autonomy in daily activities?
- Does dual-task exercise enhance the overall quality of life for Parkinson's patients? Researchers will compare a dual-task exercise program to a standard rehabilitation program. Both groups will receive 20 sessions, 2-3 times a week for two months, each lasting 45 minutes. The study will be double-blinded, meaning neither participants nor researchers involved in treatment administration and data collection will know group assignments. Randomization will be done using dedicated software to ensure unbiased group distribution.
Participants will:
- Have a confirmed diagnosis of Parkinson's disease (Movement Disorder Society criteria).
- Be in an early to moderate stage of the disease (Hoehn and Yahr score < 3).
- Be over 30 years old.
- Be able to provide informed consent.
- Have a stable medication regimen for at least three months.
Exclusions include:
- Hoehn and Yahr score ≥3.
- Severe cognitive or psychiatric disorders (e.g., dementia).
- Use of interfering medications or treatments.
- Participation in other clinical trials.
- Pregnancy or breastfeeding.
- Need for medication changes during rehabilitation. Evaluations will be conducted at baseline (T=0), after rehabilitation (T=1), and at a two-month follow-up (T=2). Assessments will include the Tinetti Balance and Gait scales, Timed Up and Go (TUG) test, VAS pain scale, TAMPA Scale for Kinesiophobia, Global Perceived Effect (GPE), Barthel Index, EuroQoL-5D-5L, and ABC Scale. UPDRS, Hoehn and Yahr scale, and MOCA Scale will be administered only at baseline (T=0).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Parkinson's Disease (Movement Disorder Society criteria).
- •Early to moderate stage of the disease (Hoehn and Yahr score < 3).
- •Age over 30 years.
- •Ability to provide informed consent.
- •Stable pharmacological therapy for at least 3 months.
排除标准
- •Hoehn and Yahr score ≥
- •Severe cognitive or psychiatric disorders (e.g., dementia).
- •Use of interfering medications or treatments.
- •Participation in another clinical trial.
- •Pregnancy or breastfeeding.
- •Need for changes in pharmacological therapy during the rehabilitation period.
研究组 & 干预措施
Dual-Task Exercise Program
This arm consists of participants assigned to receive a structured rehabilitative pathway based on dual-task exercises. This program integrates motor and cognitive tasks simultaneously, and is designed to improve balance, reduce fall risk, and enhance autonomy and quality of life in Parkinson's patients. Participants in this group will complete a total of 20 sessions, administered 2-3 times per week for a duration of two months, with each session lasting 45 minutes.
干预措施: Dual-Task Exercise (Behavioral)
Standard Rehabilitation Program
This arm consists of participants assigned to receive a standard rehabilitation program. This intervention focuses on traditional motor rehabilitation techniques and serves as the active control group for comparison with the dual-task intervention. Participants in this group will complete a total of 20 sessions, administered 2-3 times per week for a duration of two months, with each session lasting 45 minutes.
干预措施: Standard Rehabilitation (Behavioral)
结局指标
主要结局
UPDRS (Unified Parkinson's Disease Rating Scale)
时间窗: Baseline
It is a widely used scale to assess the severity of symptoms in patients with Parkinson's disease. It consists of four sections: non-motor and mental aspects, motor aspects, motor complications, and treatment. It evaluates aspects such as tremor, rigidity, bradykinesia, balance, and daily activities.
Hoehn and Yahr scale
时间窗: Baseline
It is a staging scale that classifies the severity of Parkinson's disease into five stages, from mild (stage 1) to severe (stage 5), based on the presence of motor symptoms and functional impairment.
MOCA Scale (Montreal Cognitive Assessment)
时间窗: Baseline
The MoCA is a screening tool used to assess cognitive functions. It is designed to detect mild and moderate cognitive impairments, such as those associated with dementia or other neurological conditions. The scale covers various cognitive domains, including attention, concentration, memory, language, visuospatial abilities, abstraction, calculation, and orientation. The maximum score is 30 points, and a score below 26 may indicate the presence of cognitive impairment.
TUG (Timed Up and Go test)
时间窗: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
It is a simple test that measures the time a person takes to stand up from a chair, walk three meters, turn around, return, and sit down. It is used to assess balance and fall risk.
Tinetti Balance and Gait scales
时间窗: -At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion
Two distinct but related scales: * Tinetti Balance Scale: assesses fall risk through various balance tests. * Tinetti Gait Scale: evaluates gait and the related risk of falling. Both scales are used to identify individuals at risk of falling and to monitor the effectiveness of interventions.
次要结局
- Visual Analogue Scale for pain (VAS)(-At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion)
- TAMPA Scale (Tampa Scale for Kinesiophobia)(-At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion)
- Global Perceived Effect (GPE)(-At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion)
- Barthel Index(-At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion)
- EuroQoL-5D-5L (EuroQoLD5L)(-At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion)
- ABC Scale (Activities-specific Balance Confidence Scale)(-At study enrollment (Baseline) -Immediately after completion of the 2-month rehabilitation program -At 2-month follow-up after rehabilitation program completion)
研究者
Teresa Paolucci
Professor, MD, PhD, Physical Medicine and Rehabilitation Physician
G. d'Annunzio University