Parkinson's Disease
Conditions
Keywords
Occupational Therapy, Parkinson's Disease, Feasibility, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden
Brief summary
The purpose of this study is to determine the feasibility of a RCT evaluating the effectiveness of occupational therapy in Parkinson's disease.
Detailed description
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.
Interventions
OTHERoccupational therapy
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.
Sponsors
Stichting Nuts Ohra
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
patients: * 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.
Exclusion criteria
patients: * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient: Combination of AMPS-process skills and COPM-performance measure | 0 and 3 months |
| Caregiver: Zarit Burden Inventory (ZBI) | 0 and 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Patient: AMC Linear Disability Scale (ALDS) | 0 and 3 months |
| Patient: Parkinson's Disease Questionnaire 39 (PDQ-39) | 0 and 3 months |
| Patient: Assessment of Motor and Process Skills(AMPS)- motor skills | 0 and 3 months |
| Patient and Caregiver: EQ-5D and VAS | 0 and 3 months |
| Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure | 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 and caregiver: Resource utilization | 0 and 3 months |
| Patient: Impact on Participation and Autonomy (IPA) | 0 and 3 months |
Countries
Netherlands
Outcome results
None listed