The primary objective is to evaluate the effectiveness of occupational therapy in improving daily functioning of patients with Parkinson's Disease and reducing caregivers* burden.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome/endpoint for the patient is the quality and level of
independence in daily functioning, assessed with the Assessment of Motor and
Process Skills (AMPS) and the Amsterdam Medical Centre Linear Disability Score
(ALDS). The primary outcome/ endpoint for the caregivers is their self
perceived burden of care as assessed with the Zarit Burden Inventory (ZBI). The
primary analysis will be the changes between baseline and 3 months after start
of the intervention.
Secondary outcome
Secondary outcomes/endpoints are: self perceived performance in daily
activities (patient and caregiver), participation and autonomy (patient),
quality of life (patient and caregiver), and objective burden of care
(caregiver).
Background summary
Parkinson*s disease (PD) is a complex disabling condition progressively
affecting activities, social participation and quality of life of patients and
their caregivers. Occupational Therapy (OT) aims to optimize functional
performance and engagement in meaningful activities.
Under auspices of the Dutch Association of Occupational Therapy, Parkinson
Centre Nijmegen recently developed an evidence based Guideline for OT in PD.
This guideline highlights the urgent need for high quality intervention studies
to investigate the effectiveness of OT in PD.
Study objective
The primary objective is to evaluate the effectiveness of occupational therapy
in improving daily functioning of patients with Parkinson's Disease and
reducing caregivers* burden.
Study design
A multicentre assessor blind, randomized controlled trial.
Intervention
Patients in the experimental group will receive 10 weeks (max 16 sessions) of
occupational therapy according to a treatment protocol, which is based on the
evidence based guideline *Occupational Therapy in Parkinson*s Disease* and
refined for this study. The intervention will be provided by occupational
therapists with expertise in the area of Parkinson*s Disease (ParkinsonNet
therapists). Patients and their caregivers in the control group will have no
occupational therapy intervention until their last measurement has taken place
(6 months).
Study burden and risks
All participants receive occupational therapy addressing their individual needs
in the area of daily activities within or after the study.
There are four moments of assessments for all participants: at baseline (two
visits) and 3 and 6 months after start of the intervention. The outcome
measurements are non-invasive and will take place at the patient*s home. The
total time for investment voor the measurements will be 7.5 hrs for the patient
and 2.5 hours for the caregiver. The intervention (experimental group) will
take a maximum of 16 hours over a period of 10 weeks.
There are no foreseeable risks associated with participation in the study.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria patients
1 Idiopathic Parkinson's Disease according to accepted criteria.
2 Need for assistance in daily activities
3 Home dwelling;Inclusion criteria caregivers
1 Providing informal support minimal two times a week to a patient who participates in the study
2 Available to take part in the intervention.
Exclusion criteria
1 Co morbidity with symptoms that precludes active partcipation in the intervention (e.g psychosis, severe cardiac failure). Or limitations in activities are dominated by the co morbid condition rather than by Parkinson*s Disease.
2 Current participation in other allied health research (IMPACT, PARKFIT, ERGODIM)
3 Having received occupational therapy in the last 12 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27905.091.09 |