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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03484351




Registration number
NCT03484351
Ethics application status
Date submitted
19/03/2018
Date registered
30/03/2018

Titles & IDs
Public title
The Fall Monty Activity Programme Feasibility Study
Scientific title
Evaluating the Feasibility of Providing a Newly Developed Multifactorial Falls Prevention Programme for Community-dwelling Patients After Stroke.
Secondary ID [1] 0 0
HRE2018-0104
Universal Trial Number (UTN)
Trial acronym
FallMAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Fall Monty Activity Programme (FallMAP)

Experimental: Fall Monty Activity Programme (FallMAP) - A multifactorial falls prevention activity programme


Other interventions: Fall Monty Activity Programme (FallMAP)
The programme delivered during this feasibility study will consist of a total of 12 multifactorial falls prevention group exercise sessions of 90-100 minutes in duration, followed by a 20-30 minute social activity. The sessions will be offered over a period of 8 weeks. Each session will comprise (a mix of) seven program components of the intervention: 1) falls prevention education, 2) FaME group-based exercises for strength and dynamic balance, 3) (Preparing for) home exercises, 4) Interactive, virtual reality gamefied exercises, 5) Getting on and off the floor / floorwork / safe landing \& falls technique activities, 6) Home falls hazard evaluation and 7) A social activity after the exercise session.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The participants'/staff's experiences with undergoing/delivering the FallMAP programme will be collected by means of individual semi-structured interviews according to an interview topics guide.
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* Aged over 50 and more than 6 months post-stroke.
* Living in the community.
* Having a good cognition (= 25 points on the Short Mini-Mental State Examination).
* Able to walk at least three times weekly outside the home without hands-on supervision (with or without the use of a walking aid).
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The presence of medical issues preventing someone from participating in moderate to vigorous strength and balance exercises.
* A receptive aphasia impacting on ability to follow instructions.
* The inability to provide informed consent.

Study design
Purpose of the study
Other
Allocation to intervention
NA
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
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/10/2018
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Curtin University - Perth
Recruitment postcode(s) [1] 0 0
6100 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Curtin University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lex D de Jong, PhD
Address 0 0
Curtin University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03484351