PDSAFE Stage 1 Pilot Trial
| ISRCTN | ISRCTN14719805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14719805 |
| Secondary identifying numbers | 15673 |
- Submission date
- 11/12/2013
- Registration date
- 11/12/2013
- Last edited
- 12/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
b.hounsome@soton.ac.uk
Contact information
Scientific
Faculty of Health Sciences
Southampton General Hospital Level E
Centre Block
Southampton
SO16 6YD
United Kingdom
| b.hounsome@soton.ac.uk |
Study information
| Study design | Non-randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinsons disease: Stage 1 Pilot study |
| Study objectives | 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 Parkinsons 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 Parkinsons disease who follow PDSAFE fall less than those who do not during the 6 months of treatment? |
| Ethics approval(s) | 13/SC/0538 |
| Health condition(s) or problem(s) studied | Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Parkinsons Disease; Disease: Parkinson's disease |
| Intervention | 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 | Other |
| 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 study start date | 18/11/2013 |
| Completion date | 31/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 20; UK Sample Size: 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/11/2013 |
| Date of final enrolment | 31/03/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SO16 6YD
United Kingdom
Sponsor information
University/education
Aldermoor Health Centre
Southampton
SO16 6YD
England
United Kingdom
"ROR" |
https://ror.org/01ryk1543 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
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.
