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PDSAFE Stage 1 Pilot Trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14719805
Enrollment
20
Registered
2013-12-11
Start date
2013-11-18
Completion date
Unknown
Last updated
2018-07-02

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

Conditions

Topic: Dementias and Neurodegenerative Diseases Research Network

Interventions

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. Samp

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026