Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
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, and more prone to falls. Although drugs are available to treat the symptoms of Parkinson's disease, balance control and falls do not improve. There is some evidence that physiotherapy can help but to date there is not enough evidence. This proposal is aimed at defining the benefits of physiotherapy together with the costs incurred and any health service cost savings. PDSAFE is a new personalised exercise-based treatment. The aim of this study is to find out whether people with Parkinson's disease who follow PDSAFE fall less often.

Who can participate?
People with Parkinson's disease who live at home and have experienced at least one fall in the previous 12 months.

What does the study involve?
Participants follow the PDSAFE programme, which includes exercises for balance, muscle strengthening and techniques for improving walking, freezing (unable to move), steadiness and avoiding falls. Each participant’s treatment session is videoed, transferred to a DVD or tablet computer and returned to them so that they can replay it at home. This enables multiple replays of a session as required and acts as a reminder of the activity, instructions, information and feedback.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Southampton General Hospital (UK)

When is the study starting and how long is it expected to run for?
November 2013 to March 2014

Who is funding the study?
NIHR Health Technology Assessment Programme (HTA) (UK)

Who is the main contact?
Dr Barry Hounsome

Trial website

Contact information



Primary contact

Dr Barry Hounsome


Contact details

Faculty of Health Sciences
Southampton General Hospital Level E
Centre Block
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson’s disease: Stage 1 Pilot study


Study hypothesis

PDSAFE is a novel, personalised, exercise-based 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. While there is some evidence that physiotherapy can help to improve movement and stability, to date there are insufficient research findings to quantify the benefits for PwPD.

The study to aims to assess the effectiveness and cost-effectiveness of PDSAFE, compared to routine care, comprises of two stages:

Stage 1: a pilot study.
Stage 2: a randomised controlled trial (RCT) (a separate ethics application will be submitted for Stage 2).

This ethics application refers to Stage 1 only. The current protocol provides details of the stage 1 pilot study; a separate protocol will be submitted for the RCT in stage 2 of the study. The Stage 1 pilot study will allow the newly developed PDSAFE intervention to be evaluated on a small sample of PwPD before being adopted in the stage 2 RCT. The stage 2 RCT will aim to define the benefits, together with the costs incurred and any health service cost savings, of the PDSAFE intervention. The stage 2 trial will seek to answer the question: do people with Parkinson’s disease who follow PDSAFE fall less than those who do not during the 6 months of treatment?

Ethics approval


Study design

Non-randomised interventional trial

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Parkinson’s Disease; Disease: Parkinson's disease


Therapy, For the stage 1 pilot study the intervention will take place over period of up to six weeks. A total of up to 10 sessions of therapy each lasting for one hour (30 minutes of exercises; 30 minutes of discussing/developing strategies to avoid falls) will be delivered. The programme will be videoed for the person to continue and will include advice about progression of exercise.

Sample size of up to 20 participants was deemed appropriate for the pilot trial stage of the study. The sample size for the main trial is based on a power calculation

Intervention type



Not Applicable

Drug names

Primary outcome measure

Review assessments before stage 2 RCT commences.; Timepoint(s): Baseline; 1 month; within 2 wks of 1mnth intervention completion; Baseline; falls diary over 3 mnths

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Have a confirmed Consultant’'s diagnosis of Parkinson’'s disease
2. Live at home
3. Have experienced at least one fall in the previous 12 months
4. Able to follow commands
5. Be willing to participate
6. Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type


Age group




Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Participant exclusion criteria

1. People who live in nursing homes
2. Those who are not independently mobile, i.e. in need of assistance to walk inside, or rated the highest (worst) on the Hoehn & Yahr disease severity scale
3. Previous entry or randomisation in the present trial
4. Participation in a clinical trial of an investigational medicinal product in the last 90 days

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital
SO16 6YD
United Kingdom

Sponsor information


University of Southampton (UK)

Sponsor details

Aldermoor Health Centre
SO16 6YD
United Kingdom

Sponsor type




Funder type


Funder name

NIHR Health Technology Assessment Programme (HTA) (UK) ; Grant Codes: 10/57/21

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/06/2018: Chief Investigator Prof Ann Ashburn confirmed that publication of the results of the pilot study was not planned. The results will be available in the project record held in the NIHR Journals Library. 25/05/2018: No publications found, verifying study status with principal investigator 20/04/2016: Plain English summary added.