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Trial registered on ANZCTR


Registration number
ACTRN12617001183370
Ethics application status
Approved
Date submitted
9/08/2017
Date registered
11/08/2017
Date last updated
24/10/2019
Date data sharing statement initially provided
19/11/2018
Date results information initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A tailored fall prevention program for people with Parkinson's disease
Scientific title
A tailored and multifactorial fall prevention program for people with Parkinson's disease: a single group feasibility and acceptability study
Secondary ID [1] 292614 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 304294 0
falls 304295 0
Condition category
Condition code
Neurological 303642 303642 0 0
Parkinson's disease
Injuries and Accidents 303688 303688 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a multifactorial fall prevention program (i.e. multiple interventions tailored to the individual and targeting their specific fall risk factors) which will run for 4-6 months (depending on the participant's needs). The intervention will consist of environmental modification, behavioural modification and exercise, which will be delivered to participants in their homes by occupational therapists and physiotherapists. Participants will receive 6 to 12 therapy home visits depending on their need. The ratio of physiotherapy and occupational therapy home visits will depend on each participant’s physical abilities, functional cognition, ability to engage with the different components of the intervention, identified goals and issues of safety. All participants will receive weekly phone calls between visits to monitor progress and address any intervention related problems which arise.

The environmental and behavioural components of the program will be delivered as a home and community safety package. Strategies will be discussed with the participant (and any care-partner), and implemented through the use of diaries and goal setting. Environmental adaptations to reduce fall risk will be introduced (eg, removal of clutter, improving lighting) and participants who display unsafe patterns of movement will be taught how to use cues and strategies to initiate and maintain safe movement. Participants with be provided with a home safety booklet which will be adapted to their cognitive abilities and will outline recommendations. Situational cues will be used as prompts to reinforce behaviour. Adherence to the environmental and behavioural components of the program will be monitored by the occupational therapist through discussions with the participant and any care-partner and the use of participant diaries.

The home-based exercise component of the program will be individually prescribed and delivered and will include commonly used exercises for fall prevention (www.webb.org.au) These exercises address known remediable risk factors for falls in people with PD (i.e. leg muscle weakness, poor balance and freezing of gait). Exercises will be performed in 30 minute sessions, up to 6 times per week. In order to maximise efficacy and minimise adverse events, programs will be individually prescribed and progressed according to the participant’s physical and cognitive abilities. Participants will be shown how to exercise with a stable support nearby if necessary. Exercises will also be taught to any care-partner who will provide supervision and assistance (including appropriate cueing) as required. Participants and any care partner will be provided with an exercise booklet which will include clear pictorial and simple written instructions, as well as a log book in which they will record completed exercise.
Intervention code [1] 298826 0
Prevention
Intervention code [2] 298829 0
Rehabilitation
Intervention code [3] 298830 0
Behaviour
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303004 0
Feasibility of the intervention, evaluated through:
recruitment rates
retention rates
adherence to the program and
adverse events associated with the program.
Timepoint [1] 303004 0
End of study
Primary outcome [2] 303005 0
Acceptability of the intervention and assessment process, determined from open-ended interview data
Timepoint [2] 303005 0
End of study
Secondary outcome [1] 337665 0
Falls rates collected using a falls calendar
Timepoint [1] 337665 0
Falls calendars will be collected monthly for 12 months from commencing the study.
Secondary outcome [2] 337666 0
Rate of fall related-injuries collected using the falls calendar
Timepoint [2] 337666 0
Monthly throughout the study
Secondary outcome [3] 337667 0
Proportion of fallers collected using falls calendars
Timepoint [3] 337667 0
Monthly throughout the study
Secondary outcome [4] 337668 0
Perceptions of fall risk and response to these perceptions, collected via a semi-structured interview
Timepoint [4] 337668 0
Prior to commencing the intervention
Secondary outcome [5] 337669 0
Fall prevention behaviours collected with the Falls Behavioural Scale for the Older Person questionnaire
Timepoint [5] 337669 0
Before and after the intervention
Secondary outcome [6] 337670 0
Fear of falling using the Iconographical Falls Efficacy Scale
Timepoint [6] 337670 0
Before and after the intervention
Secondary outcome [7] 337671 0
Freezing of gait using the New Freezing of Gait Questionnaire
Timepoint [7] 337671 0
Before and after the intervention
Secondary outcome [8] 337672 0
Balance using the miniBESTest
Timepoint [8] 337672 0
Before and after the intervention
Secondary outcome [9] 337673 0
Fall risk using the Physiological Profile Assessment (includes measures of visual contrast sensitivity, proprioception, quadriceps strength, hand reaction time and postural sway while standing on a rubber mat with eyes open).
Timepoint [9] 337673 0
Before and after the intervention
Secondary outcome [10] 337674 0
Walking speed (measured over 4m)
Timepoint [10] 337674 0
Before and after the intervention
Secondary outcome [11] 337675 0
Cognition measured with the Montreal Cognitive Assessment
Timepoint [11] 337675 0
Before and after the intervention
Secondary outcome [12] 337676 0
Anxiety and Depression (measured with the Hospital Anxiety and Depression Scale)
Timepoint [12] 337676 0
Before and after the intervention
Secondary outcome [13] 337677 0
Physical activity measured with the Incidental and Planned Exercise Questionnaire for older people
Timepoint [13] 337677 0
Before and after the intervention
Secondary outcome [14] 337678 0
Health-related quality of life measured with the Parkinson's disease Questionnaire-39 (PDQ-39)
Timepoint [14] 337678 0
Before and after the intervention
Secondary outcome [15] 337679 0
Pain measured with the King's Parkinson's Disease Pain Scale
Timepoint [15] 337679 0
Before and after the intervention
Secondary outcome [16] 337680 0
Care-partner burden measured with the Zarit Burden Interview questionnaire
Timepoint [16] 337680 0
Before and after the intervention
Secondary outcome [17] 337727 0
Pain measured with the Brief Pain Inventory
Timepoint [17] 337727 0
Before and after the intervention

Eligibility
Key inclusion criteria
At least 1 fall in the prior 6 months
No change to Parkinson's disease medications in the 2 weeks prior to commencing the study
Able to walk at least 10 m with or without a walking aid
Participants with significant cognitive impairment (Montreal Cognitive Assessment <19 or, a level of functional cognition that the researchers deem requires assistance to participate) will require an able care-partner who is willing to participate with them to assist them with the intervention.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical conditions which would preclude or interfere with study safety and conduct.
Severe cognitive impairment (Montreal Cognitive Assessment <5)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Mixed methods study with a multifactorial fall prevention intervention and semi-structured interviews
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Twenty participants with idiopathic PD (and where appropriate, their care-partners) will be recruited. Twenty participants will be sufficient to determine the feasibility and acceptability of this protocol, and to inform the future design of a randomised trial.

Feasibility and secondary outcomes will be explored using descriptive statistics. Any changes in secondary outcome measures between baseline and post-test will be explored with paired samples t-tests. The qualitative data analysis will be explored through analysis of the interview data.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297202 0
University
Name [1] 297202 0
The University of Sydney, Ageing in Place Seed Grant
Address [1] 297202 0
The University of Sydney
NSW 2006
Australia
Country [1] 297202 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 296212 0
None
Name [1] 296212 0
Address [1] 296212 0
Country [1] 296212 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298359 0
The University of Sydney
Ethics committee address [1] 298359 0
The University of Sydney
NSW 2006
Australia
Ethics committee country [1] 298359 0
Australia
Date submitted for ethics approval [1] 298359 0
05/07/2017
Approval date [1] 298359 0
17/08/2017
Ethics approval number [1] 298359 0

Summary
Brief summary
Despite advances in management, falls continue to be a major problem for people with Parkinson’s disease (PD). Most falls prevention research excludes people with PD with cognitive impairment; however these are the people most at risk of falls. The objective of this study is to determine the feasibility and acceptability of a multifactorial fall prevention program and assessment for people with PD, including people with impaired cognition and freezing of gait.

A mixed methods study with a single group trial of a 4 to 6 month multifactorial home-based fall prevention intervention will be conducted. The intervention will consist of behavioural modification, environmental modification and exercise. The intervention will be delivered by physiotherapists and occupational therapists.

Semi-structured interviews will be conducted with participants before and after the intervention. Before the intervention the interview will explore participant’s perceptions of risk and their response to this perceived risk, and after the intervention questions will explore intervention acceptability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76830 0
Dr Natalie Allen
Address 76830 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe, NSW, 1825
Country 76830 0
Australia
Phone 76830 0
+61293519016
Fax 76830 0
Email 76830 0
natalie.allen@sydney.edu.au
Contact person for public queries
Name 76831 0
Dr Natalie Allen
Address 76831 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe, NSW, 1825
Country 76831 0
Australia
Phone 76831 0
+61293519016
Fax 76831 0
Email 76831 0
natalie.allen@sydney.edu.au
Contact person for scientific queries
Name 76832 0
Dr Natalie Allen
Address 76832 0
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe, NSW, 1825
Country 76832 0
Australia
Phone 76832 0
+61293519016
Fax 76832 0
Email 76832 0
natalie.allen@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary