Effectiveness of Occupational Therapy in Parkinson's Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 10
- 主要终点
- Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease.
详细描述
Parkinson's disease is a complex disabling condition progressively affecting activities and participation of patients. Occupational Therapy aims to optimise functional performance and engagement in meaningful roles and activities. The lack of scientific evidence for the effectiveness of Occupational Therapy (OT) in Parkinson's Disease (PD) highlights the urgent need for high quality intervention studies. The Dutch clinical practice guideline for OT in PD (2008)offers a good basis for conducting an intervention study. The completed OTiP pilot underscored the feasibility and the need for a large scale trial.
The OTiP study evaluates the effectiveness of OT in improving daily functioning of patients 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease
- •Indication for referral to occupational therapy
- •Home dwelling
- •Inclusion criteria caregivers
- •Available for informal support minimal two times a week to a patient who participates in the study
- •Available to take part in the intervention
排除标准
- •Not capable of completing the self assessment forms (i.e. due to language problems or severe cognitive problems_MMSE score < 24).
- •Co morbidity with symptoms that interfere with actively taking part in the intervention (e.g psychosis, severe heart condition). Or limitations in activities are dominated by the co morbid condition rather than by Parkinson's Disease.
- •Current participation in other allied health research (i.e. PARKFIT)
- •Having received occupational therapy intervention in the last 3 months
研究组 & 干预措施
occupational therapy
10 weeks occupational therapy according to a protocol (OTiP protocol) based on the Dutch guidelines of occupational therapy in Parkinson's disease
干预措施: Occupational Therapy (Behavioral)
No occupational therapy
Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (6 months).
结局指标
主要结局
Canadian Occupational Performance Measure (COPM)
时间窗: 3 months
Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 months (see secondary outcome measures)
次要结局
- Parkinson's Disease Questionnaire 39 (PDQ-39)(6 months)
- Hospital Anxiety and Depression Scale (HADS)(6 months)
- Perceive Recall Plan Perform Measure (PRPP)(3 months)
- Resource utilization questionnaire(3 months)
- Becks depression Inventory (BDI)(6 months)
- The Utrecht Proactive Coping Competence list (UPCC)(6 months)
- Fatigue Severity Scale (FSS)(6 months)
- Euroqol EQ-5D(6 months)
- Zarit Burden Inventory (ZBI)(6 months)
- Objective Caregiving Burden(6 months)
- Canadian Occupational Performance Measure (COPM)(6 months)
- Activity Card Sort (ACS)(3 months)
- The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)(6 months)
- Canadian Occupational Performance Measure (COPM-satisfaction)(6 months)
- Quality of life-overall(3 months)
- Zarit Burden Inventory (ZBI)(3 months)
- Parkinson's Disease Questionnaire 39 (PDQ-39)(3 months)
- Objective Caregiving Burden(3 months)
- The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)(3 months)
- Becks depression Inventory (BDI)(3 months)
- Hospital Anxiety and Depression Scale (HADS)(3 months)
- The Utrecht Proactive Coping Competence list (UPCC)(3 months)
- Fatigue Severity Scale (FSS)(3 months)
- Canadian Occupational Performance Measure (COPM-satisfaction)(3 months)