Feasibility of a Trial Evaluating the Effectiveness of Occupational Therapy in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- Patient: Combination of AMPS-process skills and COPM-performance measure
研究概览
简要总结
The purpose of this study is to determine the feasibility of a RCT evaluating 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 recently developed Dutch clinical practice guideline for OT in PD offers a good basis for conducting an intervention study. This proposed pilot study is an important step towards setting up a large scale RCT to evaluate the effectiveness of OT in improving daily functioning of patients with PD and reducing caregivers' burden.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic Parkinson's Disease according to UK Brain Bank Criteria
- •home dwelling
- •indication for occupational therapy (according to criteria in the evidence based guideline)
- •Inclusion criteria caregivers:
- •available to provide informal support minimal two times a week to a patient who participates in the study.
排除标准
- •not capable of completing the self assessment forms (i.e. due to language or severe cognitive problems)
- •comorbidity 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 (IMPACT, PARKFIT, ERGODIM)
- •having received occupational therapy intervention in the last 12 months
研究组 & 干预措施
occupational therapy
干预措施: occupational therapy (Other)
No occupational therapy
Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (3 months).
结局指标
主要结局
Patient: Combination of AMPS-process skills and COPM-performance measure
时间窗: 0 and 3 months
Caregiver: Zarit Burden Inventory (ZBI)
时间窗: 0 and 3 months
次要结局
- Patient: Impact on Participation and Autonomy (IPA)(0 and 3 months)
- Patient: AMC Linear Disability Scale (ALDS)(0 and 3 months)
- Patient: Parkinson's Disease Questionnaire 39 (PDQ-39)(0 and 3 months)
- Patient and Caregiver: EQ-5D and VAS(0 and 3 months)
- Patient and caregiver: Resource utilization(0 and 3 months)
- Caregiver: Canadian Occupational Performance Measure (COPM)(0 and 3 months)
- Caregiver: Questionnaire Objective Caregiving Burden(0 and 3 months)
- Caregiver: SF-36(0 and 3 months)
- Patient and caregiver in intervention group: satisfaction with intervention(3 months)
- Patient: Assessment of Motor and Process Skills(AMPS)- motor skills(0 and 3 months)
- Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure(0 and 3 months)