PD REHAB

PD REHAB is a randomised controlled trial to assess the clinical and cost-effectiveness of Physiotherapy and Occupational Therapy in Parkinson's Disease.

This study is closed to recruitment and follow up has completed at the end of September 2013. Results are being prepared for publication.

Design

PD REHAB is a large, pragmatic, multicentre, randomised, controlled trial of combined occupational therapy (OT) and physiotherapy (PT) versus no therapy in patients with Parkinson's disease (PD) who report limitations in activities of daily living.

Randomisation is online, using a computer generated minimisation algorithm. The trial will necessarily be open label due to the nature of the intervention.

Aim of Study

The trial will evaluate the clinical and cost-effectiveness of combined NHS OT and PT for PD versus no therapy.

Setting

Community-based therapy in approximately 40 elderly care and neurology units throughout the UK to reflect population diversity.

Target population

Patients with PD of any age who report limitations in activities of daily living.

Intervention

PT and OT will be administered in the community. The framework for the content of the therapy will be agreed in advance by expert groups based on our previous work on standard NHS OT and the PT Evaluation Project. Training will be provided for trial therapists, who will have a spectrum of experience to ensure uniformity of practice across the country. Therapists providing the intervention will complete intervention record forms, as used in previous complex intervention trials, to allow us to monitor intervention delivery.

Measurement of outcomes and costs

The primary outcome measure will be instrumental activities of daily living measured using the Nottingham Extended Activities of Daily Living scale (NEADL) as activities of daily living (ADL) is the target of the intervention. Secondary outcomes will be: health-related quality of life (Parkinson's Disease Questionnaire 39, PDQ-39; EuroQol EQ-5D), cost-effectiveness (cost per quality adjusted life year), adverse events and carer quality of life (Carer Short Form 12, SF12). Outcomes will be assessed before randomisation and by post at 3, 9 and 15 months post randomisation.