Clinical trial NCT04134988: Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fear of Falling and Risk of Falling
Official title: Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fall Apprehension and Risk: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Falls (Accidents) in Old Age
Keywords: Fall
Older adults
Fear of falling
Serious games
Technology
Randomized controlled trial
Lead sponsor: RIVAGES
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of an adapted physical activity with an interactive gaming platform on fall apprehension and risks. Half of the participants will receive a rehabilitation program using the Medimoov gaming program, the other half will receive the standard rehabilitation program.

Detailed description: Medimoov is an innovative interactive gaming platform offering adapted physical activity. Like most serious games, it targets both physical and cognitive components. Studies that evaluate serious games lack an appropriate control group, thus this study aims to evaluate the efficacy of serious games played with the Medimoov platform on fear of falling and fall risks. This pilot study is an open randomized controlled trial in parallel groups with blind data collection for the primary outcome.

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.

Eligibility criteria: Inclusion Criteria:

* To be at least 65 years old,
* 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 answer the questionnaires,
* 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).

Primary outcomes:
measure: Change in the Score Physical Performance Battery
timeFrame: Before, at mid-term (Week 4) and at the end of the program (Week 8).
measure: Change in the Fall Efficacy Scale-International (FES-I)
timeFrame: Before, at mid-term (Week 4) and at the end of the program (Week 8).
Secondary outcomes:
measure: Change in the Victoria Stroop test
timeFrame: Before, at mid-term (Week 4) and at the end of the program (Week 8)
measure: Change in the Trail Making Test A and B
timeFrame: Before, at mid-term (Week 4) and at the end of the program (Week 8)
measure: Change in the Timed Up And Go
timeFrame: Before, at mid-term (Week 4) and at the end of the program (Week 8)
measure: Change in the One-Leg Stand test
timeFrame: Before, at mid-term (Week 4) and at the end of the program (Week 8)
measure: Satisfaction questionnaire
timeFrame: At the end of the program (Week 8)
Other outcomes:
Locations:
city: Ivry-sur-Seine
country: France
facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université
state: Val De Marne
Study officials:
affiliation: RIVAGES
name: Joël Belmin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.