A Randomised Controlled Trial of the Effectiveness of PDSAFE to prevent Falls among People with Parkinson's Disease.
The aim of PDSAFE is to improve balance and avoid falls in people with Parkinson's disease. Parkinson's disease is a common, progressive condition that affects the body's nervous system.
Over time people with Parkinson's disease 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 Parkinson's disease, 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 people with Parkinson's disease.
To address this we have developed PDSAFE, a novel personalised treatment based on the latest published research evidence and our extensive experience of managing the movement and stability problems of people with Parkinson's disease. We are conducting a trial looking to answer the question: "Do people with Parkinson's disease who follow PDSAFE fall less than those who do not during the six months of treatment?" We will also be looking at falling during the six months after treatment.
We aim to recruit 600 people with Parkinson's disease from three areas: The South and South West of England; and in Newcastle Upon Tyne. To be included, those interested in taking part must:- have a diagnosis of Parkinson's disease; live at home; have experienced at least one fall in the previous twelve months; and understand and follow instructions.
For the first three months, we ask participants to record on monthly diary sheets when, and if they experience a fall. Then each person is randomly allocated to join either the "control" group (who continue with their usual care) or the "treatment" group (who receive the PDSAFE intervention). Everyone continues to record any falls on monthly diary sheets until the end of the study. Our main measurement is 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 three, six and twelve months after they were allocated to a group.
People in the treatment group follow the PDSAFE programme which includes exercises for balance, muscle strengthening and techniques for improving walking, freezing (unable to move), steadiness and avoiding falls. It is delivered by physiotherapists in peoples' homes over a six month period. People in the control group are 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.
Interview study
We are also asking forty 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.
