Randomised controlled trial to assess the clinical- and cost-effectiveness of physiotherapy and occupational therapy in Parkinson's disease

Not Applicable

Completed

Conditions: Parkinson's disease
Nervous System Diseases

Registration Number: ISRCTN17452402

Lead Sponsor: niversity of Birmingham (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 750

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 <br>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<br>3. Hoehn and Yahr scale at entry/baseline (investigator completed) <br>4. Serious adverse events throughout trial (investigator completed)<br>5. Carer quality of life, assessed by the Short Form 12 (SF-12) (carer completed) at baseline, 3, 9 and 15 months