Effectiveness of PDSAFE to prevent falls among people with Parkinson’s disease
- Conditions
- Disease: Parkinson's diseaseParkinson diseaseNervous System DiseasesTopic: Dementias and neurodegenerationSubtopic: Parkinson's Disease
- Registration Number
- ISRCTN48152791
- Lead Sponsor
- Southampton University Hospitals NHS Trust (UK)
- Brief Summary
2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/25971244 2019 HTA results in https://www.ncbi.nlm.nih.gov/pubmed/31339100 2020 cost-effectiveness results in https://pubmed.ncbi.nlm.nih.gov/32781987/ (added 14/08/2020) 2020 analysis of therapists' delivery and experience in https://pubmed.ncbi.nlm.nih.gov/33153764/ (added 09/11/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 474
1.They have a confirmed diagnosis of Parkinson's disease
2. Live at home
3. Have experienced at least one fall in the previous 12 months
4. Able to give informed consent
5. Able to understand and follow commands
6. Able to complete a programme of exercises
7. Be willing to participate
Target Gender: Male & Female; Lower Age Limit 18 years
People who live in nursing homes and 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, will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Risk of repeat falling between 0-6 months. Fall data will be collected through self-completed monthly diary sheets from baseline to 12 months post-randomisation.
- Secondary Outcome Measures
Name Time Method <br> Secondary outcomes will include:<br> 1. Risk of repeat falling 6-12 months<br> 2. Rate of falling 0-6 and 6-12 months<br> 3. Injurious falls and near falls (from the fall diary)<br> 4. A measure of balance, turning, mobility and quality of life<br> 5. Individual levels of activity will be recorded using the Phone-FITT questionnaire<br>