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Effectiveness of PDSAFE to prevent falls among people with Parkinson’s disease

A randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN48152791
Enrollment
600
Registered
2014-04-17
Start date
2014-07-01
Completion date
Unknown
Last updated
2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Dementias and neurodegeneration

Interventions

We will recruit 600 to the pre-randomisation falls collection period, we estimate with drop outs approximately 540 will be randomly allocated to one of two groups
intervention or control. Allocation will be stratified by centre and allocated in blocks with random size of 2, 4,6 or 8. The treating therapist will access allocation on the CTU website.
DVD will be developed with the PwPD. The frequency of the intervention sessions will be faded over time, one hour twice a week for 2 month, once a week for 2 months followed by once a month for 3 mont

Sponsors

Southampton University Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcomes will include: 1. Risk of repeat falling 6-12 months 2. Rate of falling 0-6 and 6-12 months 3. Injurious falls and near falls (from the fall diary) 4. A measure of balance, turning, mobility and quality of life 5. Individual levels of activity will be recorded using the Phone-FITT questionnaire

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026