Parkinson's disease Nervous System Diseases Parkinson's disease
Conditions
Interventions
The participants will be randomly allocated to either immediate OT and PT versus no treatment for the duration of the trial.
Treatment arm: Physiotherapy and occupational therapy will be delivered in
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, no age limit 2. Idiopathic PD defined by the UK Parkinson's Disease Society Brain Bank Criteria. These criteria are in standard use throughout the NHS in the UK and were supported by the NICE guidelines. 3. PD patients who report limitations in activities of daily living (ADL). We will stratify patients according to their baseline Nottingham Extended Activities of Daily Living (NEADL) score which means we will be able to examine the efficacy of these interventions at different levels of ADL disability.
Exclusion criteria
Exclusion criteria: Current information as of 02/09/2009: 1. Dementia, as usually defined clinically by the patient's physician. From our experience in another trial, some patients with moderate to severe dementia have difficulty in completing self-assessment forms. 2. Received occupational therapy or physiotherapy in the last 1 year Initial information at time of registration: 1. Dementia, as usually defined clinically by the patient's physician. From our experience in another trial, some patients with moderate to severe dementia have difficulty in completing self-assessment forms. 2. Received occupational therapy in the last 2 years or physiotherapy in the last 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Instrumental activities of daily living (NEADL; patient completed). NEADL specifically assesses aspects of patient function to which OT and PT are directed. NEADL was originally developed for stroke trials, but has now been used more widely as a generic outcome measure, such as in intervention studies for older people with general frailty and in those with specific problems (e.g. visual impairment and respiratory disease). NEADL questionnaires will be completed at baseline, 3, 9 and 15 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life, assessed by the Parkinson's Disease Questionnaire 39 (PDQ 39) and EuroQol-5D (EQ-5D), both to be completed by the patient at baseline, 3, 9 and 15 months 2. Cost-effectiveness: cost per quality adjusted life year (EQ-5D; see first secondary outcome measure), patient-completed health economics questionnaire at 9 and 15 months 3. Hoehn and Yahr scale at entry/baseline (investigator completed) 4. Serious adverse events throughout trial (investigator completed) 5. Carer quality of life, assessed by the Short Form 12 (SF-12) (carer completed) at baseline, 3, 9 and 15 months | — |
Countries
United Kingdom
Outcome results
None listed