Parkinson's is a common, progressive condition that affects the body's nervous system. The aim of PDSAFE is to improve steadiness and avoid falls in people with Parkinson's.
Over time people with Parkinson's become less unsteady, less able to move around 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 prevent falls, but to date research findings have been lacking as to the benefits for people with Parkinson's. This proposal is aimed at defining these benefits together with the costs incurred and any health service cost savings.
The project objective is to find out whether PDSAFE is an effective way of preventing falls. We will assess whether people with Parkinson’s who receive PDSAFE fall less than those who don’t after six months and a year. 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 people with Parkinson's.
This study aims to recruit 600 people with Parkinson’s from South and South West of England. Study participants will have to be living at home, have experienced at least one fall in the past 12 months and be able to understand and follow instructions.
For the first three months, participants will be asked to keep a monthly diary to record if and when they have a fall. They will then be randomly assigned to either the control group or the PDSAFE group where they will continue to keep their diary until the study ends.
Throughout the study we’ll be recording how people, balance and walk, as well as assessing their quality of life.
Those who are in the treatment group, following the programme will have exercises for
- Muscle strengthening
- Movement strategies
There will be up to 12 face to face sessions at home with the physiotherapist reduced over a six month period; starting at twice a week and gradually reducing. Each person’s exercise session will be videoed and a DVD copy will be given to them so they can replay it, along with written exercises, reminding them of the exercises they should be doing on their own every day. People in the control group will be given a DVD about Parkinson’s and will get advice about physical activity and movement strategies at the end of the study.
As well as assessing falls and other outcomes, 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 also 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.
Goodwin VA, Pickering R, Ballinger C, Roberts H, McIntosh E, Lamb S, Nieuwboer A, Rochester L, Ashburn A, and on behalf of the PDSAFE Protocol Development Group. A multi-centre, randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson’s: study protocol. BMC Neurology 2015, 15:81
Fletcher E, Goodwin VA, Richards SH, Campbell JL, Taylor RS. An exercise intervention to prevent falls in Parkinson’s: an economic evaluation. BMC Health Services Research 2012, 12:426
Ashburn A, Pickering R, McIntosh E, Hulbert S, Rochester L, Roberts HC, Nieuwboer A, Kunkel D, Goodwin VA, Lamb SE, Ballinger C, Chivers Seymour K. Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson’s: the PDSAFE RCT. Health Technol Assess 2019;23(36).
- Professor Ann Ashburn
- Dr Helen Roberts
- Dr Claire Ballinger
- Dr Ruth Pickering