NCT04134988

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

October 11, 2019

Last Update Submit

December 17, 2019

Conditions

Falls (Accidents) in Old Age

Keywords

FallOlder adultsFear of fallingSerious gamesTechnologyRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Change in the Score Physical Performance Battery

    This 5-minute test focuses on the static balance, walks, lower limb strength and fall risk. The score varies between 0 and 12, a score under 6 indicates a low performance and a high fall risk. Higher scores mean a better outcome.

    Before, at mid-term (Week 4) and at the end of the program (Week 8).

  • Change in the Fall Efficacy Scale-International (FES-I)

    This five-minute questionnaire is composed of seven questions on daily activities and focus on the fear of falling. Each question can be scored between 1 (" Not at all concerned ") to 4 points (" Very concerned "). Higher scores mean a worse outcome.

    Before, at mid-term (Week 4) and at the end of the program (Week 8).

Secondary Outcomes (5)

  • Change in the Victoria Stroop test

    Before, at mid-term (Week 4) and at the end of the program (Week 8)

  • Change in the Trail Making Test A and B

    Before, at mid-term (Week 4) and at the end of the program (Week 8)

  • Change in the Timed Up And Go

    Before, at mid-term (Week 4) and at the end of the program (Week 8)

  • Change in the One-Leg Stand test

    Before, at mid-term (Week 4) and at the end of the program (Week 8)

  • Satisfaction questionnaire

    At the end of the program (Week 8)

Study Arms (2)

Medimoov

EXPERIMENTAL

Bi-weekly 35-minute sessions of an adaptated physical activity administered by a psychomotor therapist for 8 weeks.

Other: Medimoov

Standard rehabilitation

ACTIVE COMPARATOR

Bi-weekly 35-minute sessions of the standard psychomotor therapy for 8 weeks.

Other: Standard psychomotor therapy

Interventions

MedimoovOTHER

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.

Medimoov
Standard psychomotor therapyOTHER

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.

Standard rehabilitation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université

Ivry-sur-Seine, Val De Marne, 94200, France

RECRUITING

Related Publications (11)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 25654660BACKGROUND

  • 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.

    PMID: 26559887BACKGROUND

  • Melia G, Seilles A, Tallon G. Évaluation d'un jeu sérieux thérapeutique. 2025; 4.

    BACKGROUND

  • 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.

    PMID: 1202204BACKGROUND

  • Siegrist M. Test-Retest Reliability of Different Versions of the Stroop Test. J Psychol. 1997; 131: 299-306.

    BACKGROUND

  • 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.

    PMID: 20975251BACKGROUND

  • 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.

    PMID: 22422762BACKGROUND

  • 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.

    PMID: 21576092BACKGROUND

  • 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.

    PMID: 34435968DERIVED

Study Officials

  • Joël Belmin, MD, PhD

    RIVAGES

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nolwenn Lapierre, PhD

CONTACT

+33766673212nolwennlapierre@gmail.com

Joël Belmin, MD, PhD

CONTACT

+33149594565j.belmin@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 22, 2019

Study Start

December 9, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

December 19, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)