Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000753550
Ethics application status
Approved
Date submitted
9/07/2015
Date registered
21/07/2015
Date last updated
19/07/2019
Date data sharing statement initially provided
19/07/2019
Date results information initially provided
19/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Home-based, tailored intervention for reducing falls after stroke: the Falls After Stroke Trial (FAST) Feasibility Trial
Scientific title
Home-based, tailored intervention for reducing falls after stroke: the Falls After Stroke Trial (FAST) Feasibility Trial
Secondary ID [1] 287066 0
nil
Universal Trial Number (UTN)
Trial acronym
FAST Feasibility
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 295561 0
Falls 295562 0
Condition category
Condition code
Stroke 295830 295830 0 0
Haemorrhagic
Stroke 295831 295831 0 0
Ischaemic
Physical Medicine / Rehabilitation 295832 295832 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community dwelling-stroke survivors will be assigned to the experimental group to test the feasibility of the intervention. The experimental group will receive a home-based, tailored intervention consisting of habit forming exercise and/or safety training depending on their level of disability. For example, the faster walkers (> 0.8 m/s) will have most emphasis on habit-forming exercise, the slower walkers (< 0.4 m/s) will have most emphasis on safety training, while the middle group (0.4-0.8
m/s) will have a combination of both habit-forming exercise and safety training. Habit-forming exercise will be based on the successful Lifestyle integrated Functional Exercise program (Clemson et al., 2012). This program encourages participants to look for ways of doing more physical
activity. Activities which challenge their balance and strength will be incorporated into specific daily tasks. They will be performed intentionally and consciously until they become habitual and embedded in daily occupation. Feedback, monitoring and positive reinforcement will be used to enhance the performance of these activities and the self-efficacy of the participants. The safety intervention will focus on environmental adaptations to reduce fall hazards and protective behaviours to reduce risk. The
Westmead Home Safety Assessment (Clemson et al 1999), and the Falls Behavioural Scale for Older People, validated by Clemson and colleagues (Clemson et al., 2008a), will be used to identify environmental hazards, as well as risks, so that the participants and therapist can generate
solutions. The home-based tailored intervention will be delivered through 7 weekly home visits followed by three booster sessions at Weeks 9, 13, 19 with two phone calls during Week 15 and 23. All home visits will be pproximately 1 hour duration and all home visits and phone calls will be
delivered by a physiotherapists or an occupational therapist with experience in neurological rehabilitation. The herapists delivering the intervention and participants will keep exercise logs to monitor adherence and adverse events.
Intervention code [1] 292296 0
Prevention
Intervention code [2] 292297 0
Rehabilitation
Intervention code [3] 292298 0
Treatment: Other
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295520 0
The primary outcome measure will be falls defined according to a recent consensus statements and Cochrane review recommendations as “an unexpected event in which the participant comes to rest on the ground, floor, or lower level” (Lamb et al., 2005). Participants will self report using monthly falls calendars
Timepoint [1] 295520 0
6 months
Secondary outcome [1] 315756 0
Balance will be measured using the Berg Balance Scale (Berg et al 1992). It has demonstrate good test-retest reliability and validity in measuring balance after stroke (Berg et al 1995).
Timepoint [1] 315756 0
0 and 6 months
Secondary outcome [2] 315757 0
Balance will also be measured using the Step Test (Hill et al 1996). The test has demonstrate good test-retest reliability and validity in measuring balance after stroke ( Hill et al 1996, Blennerhasset et al
2009)
Timepoint [2] 315757 0
0 and 6 mths
Secondary outcome [3] 315758 0
Self-efficacy will be measured using the Activities Specific Balance
Confidence Scale It has demonstrated good test-retest reliability and
adequate internal consistency (Powell and Myers, 1995; ).
Timepoint [3] 315758 0
0 and 6 mths
Secondary outcome [4] 315759 0
Self-efficacy will also be measured using the Modified Falls Efficacy Scale to measure confidence in performing daily activity without risk of falling. It has demonstrated good test-retest reliability and adequate internal consistency (Lamb et al., 2005).
Timepoint [4] 315759 0
0 and 6 mths
Secondary outcome [5] 315760 0
Mobility will be assessed using the 6-min walk test (6MWT) The 6MWT will be conducted according to the recently updated guidelines (Holland et al, 2014). It is commonly used as a functional submaximal measure of oxygen uptake and exercise capacity (Solway et al., 2001) and is a valid and reliable clinical measure of walking ability in stroke survivors (Fulk et al., 2008).
Timepoint [5] 315760 0
0 and 6 mths
Secondary outcome [6] 315761 0
Mobility will also be assessed using the 10-m walk test (self-selected and fast speed: step length, and cadence). The 10-m walk test will be conducted with a moving start and finish to take into account any acceleration and deceleration.
Timepoint [6] 315761 0
0 and 6 mths
Secondary outcome [7] 315762 0
Habitual physical activity will be assessed using the Incidental and Planned Exercise Questionnaire (IPEQ) which has been validated and which provide estimates of the frequency and duration of planned and casual day-to-day activities (Delbare et al 2010)
Timepoint [7] 315762 0
0 and 6 mths
Secondary outcome [8] 315763 0
Habitual physical activity will also be assessed using the ActivPALTM, an accelerometer-based monitor to measure physical activity for 7 days. Time on feet, time in sitting and lying and steps per day will be analysed (Grant et al., 2008).
Timepoint [8] 315763 0
0 and 6 months
Secondary outcome [9] 315764 0
Community participation will be measured using the Late-Life Function and Disability Instrument which measures limitation and frequency of participation in life tasks across personal, social and community domains
(Sayers et al., 2004).
Timepoint [9] 315764 0
0 and 6 months
Secondary outcome [10] 315765 0
Health-related quality of life will be measured using the EuroQual-5D (EQ-5D) (Kind et al 2005), which provides a measure of overall health using a visual analogue scale.
Timepoint [10] 315765 0
0 and 6 mths
Secondary outcome [11] 315766 0
Adherence to Intervention schedule measured as percentage of home visits and telephone calls delivered
Timepoint [11] 315766 0
6 mths

Eligibility
Key inclusion criteria
People with stroke will be screened and invited to participate if they:
a) are within 2 years of their first stroke (either ischaemic or haemorrhagic)
b) have been discharged from formal rehabilitation and are communitydwelling
c) can walk, defined as ‘being able to walk 10 m across flat ground with or
without a gait aid’
d)are adults capable of providing consent (ie, score greater than or equal
to 20 on Mini-Mental State Examination score, Folstein et al 1975)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They will be excluded if they:
a) have moderate to severe receptive aphasia as determined by a score of less than 25/30 on the Frenchay Screening Aphasia Test (Enderby et al., 1987).

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)
Participants will be recruited via professional networks and all will be assigned to the experimental intervention for the feasibility trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not relevant
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Adherence to the intervention protocol and number of falls and proportion of fallers will be analysed descriptively as well as pre-post changes in outcomes in this feasibility trial.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Funding for large trial secured
Date of first participant enrolment
Anticipated
31/07/2015
Actual
14/09/2015
Date of last participant enrolment
Anticipated
Actual
2/11/2015
Date of last data collection
Anticipated
Actual
31/05/2016
Sample size
Target
20
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 291624 0
University
Name [1] 291624 0
Macquarie University
Country [1] 291624 0
Australia
Primary sponsor type
Individual
Name
Professor Catherine dean
Address
Dept of Health Professions
Macquarie university
Ground Floor
75 Talavera Rd
Macquarie Park
NSW 2109
Country
Australia
Secondary sponsor category [1] 290296 0
University
Name [1] 290296 0
Macquarie University
Address [1] 290296 0
Dept of Health Professions
Macquarie university
Ground Floor
75 Talavera Rd
Macquarie Park
NSW 2109
Country [1] 290296 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293155 0
Macquarie University Human Research Ethics Committee (HREC Medical Sciences)
Ethics committee address [1] 293155 0
Building C5C East
Macquarie University
NSW 2109 Australia
Ethics committee country [1] 293155 0
Australia
Date submitted for ethics approval [1] 293155 0
Approval date [1] 293155 0
17/06/2015
Ethics approval number [1] 293155 0
5201500456

Summary
Brief summary
The aim of the Falls After Stroke Trial (FAST) is to test the effect of homebased, tailored intervention to reduce falls. A sample of communitydwelling stroke survivors who have finished formal rehabilitation, and therefore are at a high risk of falling again will assigned to an experimental group (habit-forming exercise and safety training) to test the feasibility of the intervention.
The primary hypothesis is that the home-based, tailored intervention will be safe and reduce both the proportion of people falling and rate of falls over a one-year period in stroke survivors living in the community.
The secondary hypotheses are:
2. That home-based, tailored intervention will also be associated with improvements in improving: balance, self-efficacy, mobility, physical activity, community participation, and health-related quality of life.

This feasibility trial will test the experimental intervention over 6 months and evaluate feasibility of recruitment, intervention and assessment protocols as well as monitoring outcomes and adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58690 0
Prof Catherine Dean
Address 58690 0
Ground Floor
75 Talavera Road
Macquarie University NSW 2109
Country 58690 0
Australia
Phone 58690 0
+61 2 9850 6620
Fax 58690 0
Email 58690 0
[email protected]
Contact person for public queries
Name 58691 0
Prof catherine Dean
Address 58691 0
Ground Floor
75 Talavera Road
Macquarie University NSW 2109
Country 58691 0
Australia
Phone 58691 0
+61 2 9850 6620
Fax 58691 0
Email 58691 0
[email protected]
Contact person for scientific queries
Name 58692 0
Prof Catherine Dean
Address 58692 0
Ground Floor
75 Talavera Road
Macquarie University NSW 2109
Country 58692 0
Australia
Phone 58692 0
+61 2 9850 6620
Fax 58692 0
Email 58692 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
feasibility trial


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.