Ann Ashburn: A randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinsons Disease

Parkinson's disease (PD) is a common, progressive condition that affects the body's nervous system. Over time PwPD are likely to become less steady, less able to move around within their homes and outside and more prone to falls. Although drugs are available to treat the symptoms of PD, reduced balance control and falls do not respond to drugs. There is some evidence that physiotherapy can help but to date there are insufficient research findings to quantify the benefits for PwPD. This proposal is aimed at defining these benefits together with the costs incurred and any health service cost savings. Our main questions are, do PwPD who follow PDSAFE fall less than those who do not during the 6 months of treatment and during six months after treatment? PDSAFE is a novel personalised treatment (PDSAFE) based on the latest published research evidence and our extensive experience of managing the movement and stability problems of PwPD. We aim to recruit 600 PwPD from four areas in the South of England. People with a diagnosis of PD, who live at home, have experienced at least one fall in the previous 12 months and can understand and follow instructions, are the type of person we aim to recruit to the research study. For the first three months they will record on monthly diary sheets when and if they have experienced a fall. Then each person will be allocated at random to join either the control group or the treatment group. Everyone will continue to record any fall events on monthly diary sheets until the end of the study. Our main measurement is the rate of falls and the risk of falling more than once. We will also record how people turn, balance, walk and their quality of life at the start of the study and at 3, 6 and 12 months after they were allocated to a group. People in the treatment group will follow the PDSAFE programme which will include exercises for balance, muscle strengthening and techniques for improving walking, freezing (unable to move), steadiness and avoiding falls. Each personÕs treatment session will be videoed, transferred to a DVD or tablet computer and returned to them so that they can replay it at home. This will enable multiple replays of a session as required and act as a reminder of the activity, instructions, information and feedback. The intensity of the treatment will be reduced over a six month period; starting with one hour twice a week for a month, then once a week for two months followed by once a month for three months. PDSAFE will be delivered by physiotherapists in peoples' homes. People in the control group will be given a DVD with guidance on a stretching and relaxation programme. The cost of PDSAFE will be assessed using information about the treatment delivery costs and financial expenses experienced by people in the study. We will ask 40 people in the treatment group to tell us what they thought of the treatment, if they continued with PDSAFE or stopped during or after the study finished. This information will be used to further develop the treatment and enhance clinical services.