The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
191
Patients in the experimental group will receive 10 weeks (maximum 16 hours) occupational therapy according to a treatment protocol, which is based on the Dutch evidence based guideline for occupational therapy in Parkinson's Disease and refined for this study.
Meander Medisch Centrum
Amersfoort, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Tergooiziekenhuizen
Blaricum, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Canadian Occupational Performance Measure (COPM)
Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 months (see secondary outcome measures)
Time frame: 3 months
Perceive Recall Plan Perform Measure (PRPP)
Observational measure. Activity performance patient
Time frame: 3 months
Zarit Burden Inventory (ZBI)
Perceived caregiver burden.(caregiver)
Time frame: 3 months
Parkinson's Disease Questionnaire 39 (PDQ-39)
Health related Quality of life (Parkinson specific; patient)
Time frame: 3 months
Resource utilization questionnaire
For evaluating costs. (patient and caregiver)
Time frame: 3 months
Objective Caregiving Burden
Evaluating hours of care (costs). (caregiver)
Time frame: 3 months
Activity Card Sort (ACS)
Participation measure:% retained activities.(patient)
Time frame: 3 months
The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)
Satisfaction with participation (patient)
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St Jansdal
Harderwijk, Netherlands
Tergooiziekenhuizen
Hilversum, Netherlands
St. Antonius
Utrecht, Netherlands
Diakonessenhuis
Zeist, Netherlands
Gelre Ziekenhuizen
Zutphen, Netherlands
Isala Klinieken
Zwolle, Netherlands
Becks depression Inventory (BDI)
Mood and Depression. (patient)
Time frame: 3 months
Hospital Anxiety and Depression Scale (HADS)
Mood and depression. (caregiver).
Time frame: 3 months
The Utrecht Proactive Coping Competence list (UPCC)
Proactive coping skills. (patient and caregiver)
Time frame: 3 months
Fatigue Severity Scale (FSS)
Impact of fatigue (patient)
Time frame: 3 months
Canadian Occupational Performance Measure (COPM-satisfaction)
Perceived satisfaction with performance. (patient)
Time frame: 3 months
Quality of life-overall
One question on rating overall quality of life (VAS scale). (patient and caregiver).
Time frame: 3 months
Zarit Burden Inventory (ZBI)
Perceived caregiver burden. (caregiver)
Time frame: 6 months
Parkinson's Disease Questionnaire 39 (PDQ-39)
Health related Quality of life (Parkinson specific)
Time frame: 6 months
Objective Caregiving Burden
Evaluating hours of care (costs). (caregiver).
Time frame: 6 months
Euroqol EQ-5D
Quality of life. Used for patient and caregiver in evaluation of cost effectiveness
Time frame: 6 months
Canadian Occupational Performance Measure (COPM)
Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 months (follow up) wil be used in a secondary analysis and analysis of cost effectiveness.
Time frame: 6 months
Canadian Occupational Performance Measure (COPM-satisfaction)
Perceived satisfaction with performance. (patient)
Time frame: 6 months
The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)
Satisfaction with participation (patient)
Time frame: 6 months
Becks depression Inventory (BDI)
Mood and Depression. (patient)
Time frame: 6 months
Hospital Anxiety and Depression Scale (HADS)
Mood and depression. (caregiver).
Time frame: 6 months
The Utrecht Proactive Coping Competence list (UPCC)
Proactive coping skills. (patient and caregiver)
Time frame: 6 months
Fatigue Severity Scale (FSS)
Impact of fatigue (patient)
Time frame: 6 months