A Randomized Controlled Trial of Home-Based Calligraphic Handwriting Exercises in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in Manual Dexterity
研究概览
简要总结
Parkinson's disease is a progressive neurodegenerative disorder with no curative treatment currently available. Its symptoms lead to increasing limitations in daily activities, with impairments in manual dexterity being particularly relevant. Handwriting difficulties are common in patients with Parkinson's disease; however, it remains unclear whether a rehabilitation program based on handwriting exercises can improve overall manual dexterity and daily functioning.
This randomized, single-blind controlled trial aims to evaluate the effects of a 12-week home-based calligraphic handwriting exercise program on manual dexterity in patients with Parkinson's disease. Participants will be recruited from the Movement Disorders Clinic of Hospital 12 de Octubre (Madrid, Spain) and randomly assigned to either an intervention group or a control group.
Manual dexterity will be primarily assessed using the Purdue Pegboard Test across scheduled study visits. Secondary outcomes will include measures of dexterity related to activities of daily living, quality of life, and motor function.
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40 to 80 years
- •Clinical diagnosis of Parkinson's disease according to the UK Brain Bank criteria.
- •Hoehn and Yahr stage 1 to 4
- •Assessed in the ON-medication state (approximately 90 minutes after levodopa intake)
- •Stable antiparkinsonian treatment for at least 4 weeks prior to study entry and maintained throughout the study period
排除标准
- •Parkinson's disease-related dementia, defined as a Montreal Cognitive Assessment (MoCA) score < 21
- •Upper limb comorbidities unrelated to Parkinson's disease that could interfere ith exercise performance (e.g., arthritis, recent fractures, stroke sequelae, or peripheral neuropathy)
- •Severe tremor or severe dyskinesias affecting the dominant hand, defined as:
- •a score ≥ 3 on UPDRS-III items 20 or 22, or
- •score ≥ 2 on UPDRS-IV item 33
研究组 & 干预措施
Calligraphic Handwriting Exercise Program
Participants assigned to this group will perform a structured home-based calligraphic handwriting exercise program designed to improve fine motor control and manual dexterity over a 12-week period.
干预措施: Calligraphic Handwriting Exercise Program (Behavioral)
Usual Care
Participants assigned to this group will receive usual clinical care and will not participate in the calligraphic handwriting exercise program during the study period.
结局指标
主要结局
Change in Manual Dexterity
时间窗: Baseline and up to 12 weeks
Manual dexterity will be assessed using the Purdue Pegboard Test. The primary outcome will be the change in Purdue Pegboard Test score from baseline across scheduled study visits.
次要结局
未报告次要终点
研究者
Sara Llamas Velasco
Postdoctoral Researcher in Neurology
Hospital Universitario 12 de Octubre