The Fall Monty Activity Programme Feasibility Study (FallMAP)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Fall Monty Activity Programme (FallMAP)
Sponsored by

About this trial
This is an interventional health services research trial for Stroke focused on measuring Falls
Eligibility 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.
Sites / Locations
- Curtin University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fall Monty Activity Programme (FallMAP)
Arm Description
A multifactorial falls prevention activity programme
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03484351
Brief Title
The Fall Monty Activity Programme Feasibility Study
Acronym
FallMAP
Official Title
Evaluating the Feasibility of Providing a Newly Developed Multifactorial Falls Prevention Programme for Community-dwelling Patients After Stroke.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
October 2, 2018 (Actual)
Study Completion Date
October 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Curtin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Falls
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fall Monty Activity Programme (FallMAP)
Arm Type
Experimental
Arm Description
A multifactorial falls prevention activity programme
Intervention Type
Other
Intervention Name(s)
Fall Monty Activity Programme (FallMAP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Qualitative interview data collected after the 12-session programme will be transcribed verbatim, coded, and analysed using (qualitative) thematic analysis.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lex D de Jong, PhD
Organizational Affiliation
Curtin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Curtin University
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23728680
Citation
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.
Results Reference
background
PubMed Identifier
18456791
Citation
Ashburn 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.
Results Reference
background
PubMed Identifier
18787199
Citation
Sackley 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.
Results Reference
background
PubMed Identifier
17141637
Citation
Mackintosh 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.
Results Reference
background
PubMed Identifier
15977453
Citation
Mackintosh 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.
Results Reference
background
PubMed Identifier
19235120
Citation
Weerdesteyn V, de Niet M, van Duijnhoven HJ, Geurts AC. Falls in individuals with stroke. J Rehabil Res Dev. 2008;45(8):1195-213.
Results Reference
background
PubMed Identifier
19689757
Citation
Rigby 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.
Results Reference
background
PubMed Identifier
10884456
Citation
Ramnemark 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.
Results Reference
background
PubMed Identifier
27268565
Citation
Goh 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.
Results Reference
background
PubMed Identifier
24597937
Citation
Woodman 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.
Results Reference
background
PubMed Identifier
27707740
Citation
Sherrington 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.
Results Reference
background
PubMed Identifier
27633021
Citation
van 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.
Results Reference
background
PubMed Identifier
19370674
Citation
Gillespie 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.
Results Reference
background
PubMed Identifier
20616328
Citation
Batchelor 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.
Results Reference
background
PubMed Identifier
12535321
Citation
Skelton 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.
Results Reference
background
PubMed Identifier
20817938
Citation
Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.
Results Reference
background
PubMed Identifier
26093805
Citation
Corbetta D, Imeri F, Gatti R. Rehabilitation that incorporates virtual reality is more effective than standard rehabilitation for improving walking speed, balance and mobility after stroke: a systematic review. J Physiother. 2015 Jul;61(3):117-24. doi: 10.1016/j.jphys.2015.05.017. Epub 2015 Jun 18.
Results Reference
background
PubMed Identifier
25865864
Citation
Hill AM, McPhail SM, Waldron N, Etherton-Beer C, Ingram K, Flicker L, Bulsara M, Haines TP. Fall rates in hospital rehabilitation units after individualised patient and staff education programmes: a pragmatic, stepped-wedge, cluster-randomised controlled trial. Lancet. 2015 Jun 27;385(9987):2592-9. doi: 10.1016/S0140-6736(14)61945-0. Epub 2015 Apr 9.
Results Reference
background
PubMed Identifier
23788832
Citation
Luck T, Motzek T, Luppa M, Matschinger H, Fleischer S, Sesselmann Y, Roling G, Beutner K, Konig HH, Behrens J, Riedel-Heller SG. Effectiveness of preventive home visits in reducing the risk of falls in old age: a randomized controlled trial. Clin Interv Aging. 2013;8:697-702. doi: 10.2147/CIA.S43284. Epub 2013 Jun 12.
Results Reference
background
PubMed Identifier
10591231
Citation
Cumming RG, Thomas M, Szonyi G, Salkeld G, O'Neill E, Westbury C, Frampton G. Home visits by an occupational therapist for assessment and modification of environmental hazards: a randomized trial of falls prevention. J Am Geriatr Soc. 1999 Dec;47(12):1397-402. doi: 10.1111/j.1532-5415.1999.tb01556.x.
Results Reference
background
PubMed Identifier
27309492
Citation
Harrison M, Ryan T, Gardiner C, Jones A. Psychological and emotional needs, assessment, and support post-stroke: a multi-perspective qualitative study. Top Stroke Rehabil. 2017 Mar;24(2):119-125. doi: 10.1080/10749357.2016.1196908. Epub 2016 Jun 16.
Results Reference
background
PubMed Identifier
28438076
Citation
Tse T, Binte Yusoff SZ, Churilov L, Ma H, Davis S, Donnan GA, Carey LM; START research team. Increased work and social engagement is associated with increased stroke specific quality of life in stroke survivors at 3 months and 12 months post-stroke: a longitudinal study of an Australian stroke cohort. Top Stroke Rehabil. 2017 Sep;24(6):405-414. doi: 10.1080/10749357.2017.1318339. Epub 2017 Apr 24.
Results Reference
background
PubMed Identifier
27592402
Citation
Moon Y, Sosnoff JJ. Safe Landing Strategies During a Fall: Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2017 Apr;98(4):783-794. doi: 10.1016/j.apmr.2016.08.460. Epub 2016 Aug 31.
Results Reference
background
PubMed Identifier
9596532
Citation
Hsiao ET, Robinovitch SN. Common protective movements govern unexpected falls from standing height. J Biomech. 1998 Jan;31(1):1-9. doi: 10.1016/s0021-9290(97)00114-0.
Results Reference
background
PubMed Identifier
12757814
Citation
DeGoede KM, Ashton-Miller JA, Schultz AB. Fall-related upper body injuries in the older adult: a review of the biomechanical issues. J Biomech. 2003 Jul;36(7):1043-53. doi: 10.1016/s0021-9290(03)00034-4.
Results Reference
background
PubMed Identifier
19407919
Citation
Groen BE, Smulders E, de Kam D, Duysens J, Weerdesteyn V. Martial arts fall training to prevent hip fractures in the elderly. Osteoporos Int. 2010 Feb;21(2):215-21. doi: 10.1007/s00198-009-0934-x. Epub 2009 May 1.
Results Reference
background
PubMed Identifier
21479777
Citation
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
Results Reference
background
PubMed Identifier
10512918
Citation
Duncan PW, Wallace D, Lai SM, Johnson D, Embretson S, Laster LJ. The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke. 1999 Oct;30(10):2131-40. doi: 10.1161/01.str.30.10.2131.
Results Reference
background
PubMed Identifier
16649886
Citation
Kollen B, Kwakkel G, Lindeman E. Time dependency of walking classification in stroke. Phys Ther. 2006 May;86(5):618-25.
Results Reference
background
PubMed Identifier
17908575
Citation
Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.
Results Reference
background
PubMed Identifier
18292215
Citation
Blum L, Korner-Bitensky N. Usefulness of the Berg Balance Scale in stroke rehabilitation: a systematic review. Phys Ther. 2008 May;88(5):559-66. doi: 10.2522/ptj.20070205. Epub 2008 Feb 21.
Results Reference
background
PubMed Identifier
12422327
Citation
Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.
Results Reference
background
PubMed Identifier
16180952
Citation
Whitney SL, Wrisley DM, Marchetti GF, Gee MA, Redfern MS, Furman JM. Clinical measurement of sit-to-stand performance in people with balance disorders: validity of data for the Five-Times-Sit-to-Stand Test. Phys Ther. 2005 Oct;85(10):1034-45.
Results Reference
background
PubMed Identifier
20298832
Citation
Mong Y, Teo TW, Ng SS. 5-repetition sit-to-stand test in subjects with chronic stroke: reliability and validity. Arch Phys Med Rehabil. 2010 Mar;91(3):407-13. doi: 10.1016/j.apmr.2009.10.030.
Results Reference
background
PubMed Identifier
19520733
Citation
Beninato M, Portney LG, Sullivan PE. Using the International Classification of Functioning, Disability and Health as a framework to examine the association between falls and clinical assessment tools in people with stroke. Phys Ther. 2009 Aug;89(8):816-25. doi: 10.2522/ptj.20080160. Epub 2009 Jun 11.
Results Reference
background
PubMed Identifier
22915174
Citation
Donath L, Zahner L, Roth R, Fricker L, Cordes M, Hanssen H, Schmidt-Trucksass A, Faude O. Balance and gait performance after maximal and submaximal endurance exercise in seniors: is there a higher fall-risk? Eur J Appl Physiol. 2013 Mar;113(3):661-9. doi: 10.1007/s00421-012-2471-0. Epub 2012 Aug 23.
Results Reference
background
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The Fall Monty Activity Programme Feasibility Study
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