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The Fall Monty Activity Programme Feasibility Study (FallMAP)

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ClinicalTrials.gov Identifier: NCT03484351
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Lex de Jong, Curtin University

Study Description
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Brief Summary:

Between 45-73% of people who have had a stroke fall over in the months and years following their stroke. Falls not only lead to injuries such as broken hips, but they may also lead to fear of falling. As a consequence people can get fearful to walk, keep up their household tasks and their social activities such as visiting friends and family.

Research has shown that exercises for strength and balance can help both older people and patients after stroke to get fitter and healthier and help to prevent them from having a fall. People also have less falls if they have learned about falls facts and home safety precautions. Research has further suggested that people have less fear of falling and less injuries from a fall if they have learned how to fall ('safe landing' strategies). Based on these research findings the researchers have developed a new falls prevention programme called the Fall Monty Activity Programme (FallMAP). This programme aims to aid in functional recovery and reduce falls by combining a mix of activities such as falls education, strength and balance exercises, and activities that teach people how to get up from the floor and how to fall safely.

Especially because people with residual impairments following a stroke have an increased risk of a fall, the feasibility of this programme will be tested in a small group of people after stroke first. This study is a first step in establishing whether the different components of the FallMAP are acceptable and practical for both patients after stroke and staff who deliver the program. In particular, it is important to evaluate if it is feasible to provide the seven combined components as one comprehensive programme. Secondly, the question whether participating in the programme can positively influence the participants' fear of falling, quality of life, leg strength, balance and mobility will be explored. If this feasibility study suggests the programme can work in the clinical setting, then a definitive randomised controlled trial will be proposed in order to look at whether the full programme is effective at reducing falls in patients after stroke.


Condition or disease Intervention/treatment Phase
Stroke Other: Fall Monty Activity Programme (FallMAP) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating the Feasibility of Providing a Newly Developed Multifactorial Falls Prevention Programme for Community-dwelling Patients After Stroke.
Actual Study Start Date : April 9, 2018
Actual Primary Completion Date : October 2, 2018
Actual Study Completion Date : October 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fall Monty Activity Programme (FallMAP)
A multifactorial falls prevention activity programme
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]
    Qualitative interview data collected after the 12-session programme will be transcribed verbatim, coded, and analysed using (qualitative) thematic analysis.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484351


Locations
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Australia, Western Australia
Curtin University
Perth, Western Australia, Australia, 6100
Sponsors and Collaborators
Curtin University
Investigators
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Principal Investigator: Lex D de Jong, PhD Curtin University
  Study Documents (Full-Text)

Documents provided by Lex de Jong, Curtin University:
Study Protocol and Statistical Analysis Plan  [PDF] March 5, 2018
Informed Consent Form  [PDF] March 5, 2018

More Information
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Publications:

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Responsible Party: Lex de Jong, Dr. Lex D. de Jong, Curtin University
ClinicalTrials.gov Identifier: NCT03484351    
Other Study ID Numbers: HRE2018-0104
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lex de Jong, Curtin University:
Falls
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases