Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fear of Falling and Risk of Falling
NCT ID: NCT04134988
Last Updated: 2019-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-12-09
2020-09-30
Brief Summary
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Detailed Description
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The intervention group will follow bi-weekly sessions with Medimoov. The control group will follow the usual rehabilitation program: the standard psychomotor therapy program.
Both interventions will be consistent with rehabilitation programs prescribed by participants' physicians. Each intervention, guided by a psychomotor therapist, will last eight weeks with bi-weekly sessions of 35 minutes.
Participants will be randomly assigned to one of the two groups. Three assessments will be conducted focusing on physical and cognitive capacities. The first assessment will be conducted five or fewer days before the beginning of the rehabilitation program, the second will occur during week 4 and the third one during week 8, at the end of the rehabilitation program. Assessments will be blinded: assessors will not know the assigned group of each participant.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Medimoov
Bi-weekly 35-minute sessions of an adaptated physical activity administered by a psychomotor therapist for 8 weeks.
Medimoov
The Medimoov game platform (created by NaturalPad©) is a physio-gaming medical device, which comes in the form of functional and postural rehabilitation software. Associating movement capture and videogames, Medimoov contributes to the older adults' motivation and engagement and offers adapted physical activities.
Standard rehabilitation
Bi-weekly 35-minute sessions of the standard psychomotor therapy for 8 weeks.
Standard psychomotor therapy
Psychomotor therapists are among the professionals recommended by the French national health authority. They intervene on psychomotor dimensions of falls, namely the motor, sensory and cognitive aspects.
Interventions
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Medimoov
The Medimoov game platform (created by NaturalPad©) is a physio-gaming medical device, which comes in the form of functional and postural rehabilitation software. Associating movement capture and videogames, Medimoov contributes to the older adults' motivation and engagement and offers adapted physical activities.
Standard psychomotor therapy
Psychomotor therapists are among the professionals recommended by the French national health authority. They intervene on psychomotor dimensions of falls, namely the motor, sensory and cognitive aspects.
Eligibility Criteria
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Inclusion Criteria
* To be able to give consent,
* French-speaking,
* To be able to stand upright in a bipedal position, feet together for a time greater than 10 seconds with/without an assistive device,
* To have a score ≥13 on the Short Fall Efficacy Scale (FES-I) (moderate fear of falling).
Exclusion Criteria
* Not being able to correctly distinguish the elements on the screen,
* To be in palliative care,
* To be under a legal protection measure,
* To score under 16 at the Mini Mental State Examination,
* To have an acute pathology,
* To have had recent hip surgery (\<2 months).
65 Years
ALL
No
Sponsors
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Joel Belmin
OTHER
Responsible Party
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Joel Belmin
Professor
Principal Investigators
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Joël Belmin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
RIVAGES
Locations
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Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université
Ivry-sur-Seine, Val De Marne, France
Countries
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Central Contacts
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Facility Contacts
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Nolwenn Lapierre, PhD
Role: primary
joël Belmin, MD, PhD
Role: backup
References
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Dargent-Molina P, Cassou B. Prévention des chutes chez les personnes âgées de plus de 75 ans vivant à leur domicile: analyse des interventions efficaces et perspectives de santé publique. Bull Épidémiologique Hebd. 2017;16-17:336-43.
Tallon G, Seilles A, Melia G, et al. Intérêt du serious game Medimoov pour améliorer l'autonomie fonctionnelle chez la personne âgée institutionnalisée. Montpellier, 2015.
Lister C, West JH, Cannon B, Sax T, Brodegard D. Just a fad? Gamification in health and fitness apps. JMIR Serious Games. 2014 Aug 4;2(2):e9. doi: 10.2196/games.3413.
Skjaeret N, Nawaz A, Morat T, Schoene D, Helbostad JL, Vereijken B. Exercise and rehabilitation delivered through exergames in older adults: An integrative review of technologies, safety and efficacy. Int J Med Inform. 2016 Jan;85(1):1-16. doi: 10.1016/j.ijmedinf.2015.10.008. Epub 2015 Oct 28.
Melia G, Seilles A, Tallon G. Évaluation d'un jeu sérieux thérapeutique. 2025; 4.
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
Siegrist M. Test-Retest Reliability of Different Versions of the Stroop Test. J Psychol. 1997; 131: 299-306.
Hauer KA, Kempen GI, Schwenk M, Yardley L, Beyer N, Todd C, Oster P, Zijlstra GA. Validity and sensitivity to change of the falls efficacy scales international to assess fear of falling in older adults with and without cognitive impairment. Gerontology. 2011;57(5):462-72. doi: 10.1159/000320054. Epub 2010 Oct 22.
Freire AN, Guerra RO, Alvarado B, Guralnik JM, Zunzunegui MV. Validity and reliability of the short physical performance battery in two diverse older adult populations in Quebec and Brazil. J Aging Health. 2012 Aug;24(5):863-78. doi: 10.1177/0898264312438551. Epub 2012 Mar 15.
Wagner S, Helmreich I, Dahmen N, Lieb K, Tadic A. Reliability of three alternate forms of the trail making tests a and B. Arch Clin Neuropsychol. 2011 Jun;26(4):314-21. doi: 10.1093/arclin/acr024. Epub 2011 May 15.
Lapierre N, Um Din N, Igout M, Chevrier J, Belmin J. Effects of a Rehabilitation Program Using a Patient-Personalized Exergame on Fear of Falling and Risk of Falls in Vulnerable Older Adults: Protocol for a Randomized Controlled Group Study. JMIR Res Protoc. 2021 Aug 26;10(8):e24665. doi: 10.2196/24665.
Other Identifiers
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MEDIMOOV_01
Identifier Type: -
Identifier Source: org_study_id