StrokeFallMAPNCT03484351
The Fall Monty Activity Programme Feasibility Study
A study testing Fall Monty Activity Programme (FallMAP) in people with Stroke, run by Curtin University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Fall Monty Activity Programme (FallMAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Apr 2018to 2 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Feasibility of Providing a Newly Developed Multifactorial Falls Prevention Programme for Community-dwelling Patients After Stroke.
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.
- Conditions
- Stroke
- Being tested
- Fall Monty Activity Programme (FallMAP)
- Keywords
- Falls
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall Monty Activity Programme (FallMAP)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Fall Monty Activity Programme (FallMAP) | Experimental | A multifactorial falls prevention activity programme Receives: Other: Fall Monty Activity Programme (FallMAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Qualitative interview data collected after the 12-session programme will be transcribed verbatim, coded, and analysed using (qualitative) thematic analysis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start9 Apr 2018
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lex de Jong, Curtin University
- Investigators
- Lex D de Jong, PhD, Principal investigator, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484351
- Sponsor's protocol ID
- HRE2018-0104
- Acronym
- FallMAP
- Status last verified
- Oct 2018
- First submitted
- 19 Mar 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Verheyden GS, Weerdesteyn V, Pickering RM, Kunkel D, Lennon S, Geurts AC, Ashburn A. Interventions for preventing falls in people after stroke. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008728. doi: 10.1002/14651858.CD008728.pub2.
PubMed 23728680Ashburn A, Hyndman D, Pickering R, Yardley L, Harris S. Predicting people with stroke at risk of falls. Age Ageing. 2008 May;37(3):270-6. doi: 10.1093/ageing/afn066.
PubMed 18456791Sackley C, Brittle N, Patel S, Ellins J, Scott M, Wright C, Dewey ME. The prevalence of joint contractures, pressure sores, painful shoulder, other pain, falls, and depression in the year after a severely disabling stroke. Stroke. 2008 Dec;39(12):3329-34. doi: 10.1161/STROKEAHA.108.518563. Epub 2008 Sep 11.
PubMed 18787199Mackintosh SF, Hill KD, Dodd KJ, Goldie PA, Culham EG. Balance score and a history of falls in hospital predict recurrent falls in the 6 months following stroke rehabilitation. Arch Phys Med Rehabil. 2006 Dec;87(12):1583-9. doi: 10.1016/j.apmr.2006.09.004.
PubMed 17141637Mackintosh SF, Goldie P, Hill K. Falls incidence and factors associated with falling in older, community-dwelling, chronic stroke survivors (> 1 year after stroke) and matched controls. Aging Clin Exp Res. 2005 Apr;17(2):74-81. doi: 10.1007/BF03324577.
PubMed 15977453Weerdesteyn V, de Niet M, van Duijnhoven HJ, Geurts AC. Falls in individuals with stroke. J Rehabil Res Dev. 2008;45(8):1195-213.
PubMed 19235120Rigby H, Gubitz G, Phillips S. A systematic review of caregiver burden following stroke. Int J Stroke. 2009 Aug;4(4):285-92. doi: 10.1111/j.1747-4949.2009.00289.x.
PubMed 19689757Ramnemark A, Nilsson M, Borssen B, Gustafson Y. Stroke, a major and increasing risk factor for femoral neck fracture. Stroke. 2000 Jul;31(7):1572-7. doi: 10.1161/01.str.31.7.1572.
PubMed 10884456Goh HT, Nadarajah M, Hamzah NB, Varadan P, Tan MP. Falls and Fear of Falling After Stroke: A Case-Control Study. PM R. 2016 Dec;8(12):1173-1180. doi: 10.1016/j.pmrj.2016.05.012. Epub 2016 Jun 4.
PubMed 27268565Woodman P, Riazi A, Pereira C, Jones F. Social participation post stroke: a meta-ethnographic review of the experiences and views of community-dwelling stroke survivors. Disabil Rehabil. 2014;36(24):2031-43. doi: 10.3109/09638288.2014.887796. Epub 2014 Mar 6.
PubMed 24597937Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(24):1750-1758. doi: 10.1136/bjsports-2016-096547. Epub 2016 Oct 4.
PubMed 27707740van Duijnhoven HJ, Heeren A, Peters MA, Veerbeek JM, Kwakkel G, Geurts AC, Weerdesteyn V. Effects of Exercise Therapy on Balance Capacity in Chronic Stroke: Systematic Review and Meta-Analysis. Stroke. 2016 Oct;47(10):2603-10. doi: 10.1161/STROKEAHA.116.013839. Epub 2016 Sep 15.
PubMed 27633021Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007146. doi: 10.1002/14651858.CD007146.pub2.
PubMed 19370674Batchelor F, Hill K, Mackintosh S, Said C. What works in falls prevention after stroke?: a systematic review and meta-analysis. Stroke. 2010 Aug;41(8):1715-22. doi: 10.1161/STROKEAHA.109.570390. Epub 2010 Jul 8.
PubMed 20616328Skelton DA, Beyer N. Exercise and injury prevention in older people. Scand J Med Sci Sports. 2003 Feb;13(1):77-85. doi: 10.1034/j.1600-0838.2003.00300.x.
PubMed 12535321
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of Providing a Newly Developed Multifactorial Falls Prevention Programme for Community-dwelling Patients After Stroke.
- ClinicalTrials.gov ID
- NCT03484351
- Acronym / sponsor ID
- FallMAP / HRE2018-0104
- Conditions
- Stroke
- Keywords
- Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Curtin UniversityUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fall Monty Activity Programme (FallMAP) | Experimental | Other: Fall Monty Activity Programme (FallMAP)A multifactorial falls prevention activity programme |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Fall Monty Activity Programme (FallMAP) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Background: PubMed 23728680Verheyden GS, Weerdesteyn V, Pickering RM, Kunkel D, Lennon S, Geurts AC, Ashburn A. Interventions for preventing falls in people after stroke. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008728. doi: 10.1002/14651858.CD008728.pub2.
- Background: PubMed 18456791Ashburn A, Hyndman D, Pickering R, Yardley L, Harris S. Predicting people with stroke at risk of falls. Age Ageing. 2008 May;37(3):270-6. doi: 10.1093/ageing/afn066.
- Background: PubMed 18787199Sackley C, Brittle N, Patel S, Ellins J, Scott M, Wright C, Dewey ME. The prevalence of joint contractures, pressure sores, painful shoulder, other pain, falls, and depression in the year after a severely disabling stroke. Stroke. 2008 Dec;39(12):3329-34. doi: 10.1161/STROKEAHA.108.518563. Epub 2008 Sep 11.
- Background: PubMed 17141637Mackintosh SF, Hill KD, Dodd KJ, Goldie PA, Culham EG. Balance score and a history of falls in hospital predict recurrent falls in the 6 months following stroke rehabilitation. Arch Phys Med Rehabil. 2006 Dec;87(12):1583-9. doi: 10.1016/j.apmr.2006.09.004.
- Background: PubMed 15977453Mackintosh SF, Goldie P, Hill K. Falls incidence and factors associated with falling in older, community-dwelling, chronic stroke survivors (> 1 year after stroke) and matched controls. Aging Clin Exp Res. 2005 Apr;17(2):74-81. doi: 10.1007/BF03324577.
- Background: PubMed 19235120Weerdesteyn V, de Niet M, van Duijnhoven HJ, Geurts AC. Falls in individuals with stroke. J Rehabil Res Dev. 2008;45(8):1195-213.
- Background: PubMed 19689757Rigby H, Gubitz G, Phillips S. A systematic review of caregiver burden following stroke. Int J Stroke. 2009 Aug;4(4):285-92. doi: 10.1111/j.1747-4949.2009.00289.x.
- Background: PubMed 10884456Ramnemark A, Nilsson M, Borssen B, Gustafson Y. Stroke, a major and increasing risk factor for femoral neck fracture. Stroke. 2000 Jul;31(7):1572-7. doi: 10.1161/01.str.31.7.1572.
- Background: PubMed 27268565Goh HT, Nadarajah M, Hamzah NB, Varadan P, Tan MP. Falls and Fear of Falling After Stroke: A Case-Control Study. PM R. 2016 Dec;8(12):1173-1180. doi: 10.1016/j.pmrj.2016.05.012. Epub 2016 Jun 4.
- Background: PubMed 24597937Woodman P, Riazi A, Pereira C, Jones F. Social participation post stroke: a meta-ethnographic review of the experiences and views of community-dwelling stroke survivors. Disabil Rehabil. 2014;36(24):2031-43. doi: 10.3109/09638288.2014.887796. Epub 2014 Mar 6.
- Background: PubMed 27707740Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(24):1750-1758. doi: 10.1136/bjsports-2016-096547. Epub 2016 Oct 4.
- Background: PubMed 27633021van Duijnhoven HJ, Heeren A, Peters MA, Veerbeek JM, Kwakkel G, Geurts AC, Weerdesteyn V. Effects of Exercise Therapy on Balance Capacity in Chronic Stroke: Systematic Review and Meta-Analysis. Stroke. 2016 Oct;47(10):2603-10. doi: 10.1161/STROKEAHA.116.013839. Epub 2016 Sep 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lex D de Jong, PhD principal investigator
Curtin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall Monty Activity Programme (FallMAP) in people with Stroke, run by Curtin University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484351, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.