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Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fear of Falling and Risk of Falling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134988
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Joel Belmin, RIVAGES

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.

Condition or disease Intervention/treatment Phase
Falls (Accidents) in Old Age Other: Medimoov Other: Standard psychomotor therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fall Apprehension and Risk: A Randomized Controlled Trial
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medimoov
Bi-weekly 35-minute sessions of an adaptated physical activity administered by a psychomotor therapist for 8 weeks.
Other: 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.

Active Comparator: Standard rehabilitation
Bi-weekly 35-minute sessions of the standard psychomotor therapy for 8 weeks.
Other: 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.




Primary Outcome Measures :
  1. Change in the Score Physical Performance Battery [ Time Frame: Before, at mid-term (Week 4) and at the end of the program (Week 8). ]
    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.

  2. Change in the Fall Efficacy Scale-International (FES-I) [ Time Frame: Before, at mid-term (Week 4) and at the end of the program (Week 8). ]
    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.


Secondary Outcome Measures :
  1. Change in the Victoria Stroop test [ Time Frame: Before, at mid-term (Week 4) and at the end of the program (Week 8) ]
    This 5-minute test to evaluate inhibition and selective attention is scored according to the realization time and errors in realization. The test includes three parts, the time of realization and the number or error are compared to a standard for each part of the test. Higher scores mean a worse outcome.

  2. Change in the Trail Making Test A and B [ Time Frame: Before, at mid-term (Week 4) and at the end of the program (Week 8) ]
    This evaluation focuses on executive functions including number and letter recognition, cognitive flexibility, visual scan, and motor functions. This evaluation lasts 10 minutes. The score of each test (A and B) is the number of seconds required to complete the task and is compared to a standard: for the Test A a score above 78 indicates a deficiency, for the Test B a score above 273 indicates a deficiency. Higher scores mean a worse outcome.

  3. Change in the Timed Up And Go [ Time Frame: Before, at mid-term (Week 4) and at the end of the program (Week 8) ]
    This test consists in standing up from a chair with armrest, walking three meters, turning around and coming back to sit. The test lasts less than one minute, fall risk is identified if the score is inferior than one and the duration of the test superior to 20 seconds.

  4. Change in the One-Leg Stand test [ Time Frame: Before, at mid-term (Week 4) and at the end of the program (Week 8) ]
    Standing in one leg as long as possible on each foot. This time is compared to a standard. Higher scores mean a better outcome.

  5. Satisfaction questionnaire [ Time Frame: At the end of the program (Week 8) ]
    Composed of 10 questions, its aim is to evaluate the participants' experience and the self-confidence after the rehabilitation program. The questionnaire lasts approximately 2 minutes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134988


Contacts
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Contact: Nolwenn Lapierre, PhD +33766673212 nolwennlapierre@gmail.com
Contact: Joël Belmin, MD, PhD +33149594565 j.belmin@aphp.fr

Locations
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France
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université Recruiting
Ivry-sur-Seine, Val De Marne, France, 94200
Contact: Nolwenn Lapierre, PhD    +33766673212    nolwennlapierre@gmail.com   
Contact: joël Belmin, MD, PhD    +149594565    j.belmin@aphp.fr   
Sponsors and Collaborators
Joel Belmin
Investigators
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Principal Investigator: Joël Belmin, MD, PhD RIVAGES
Publications:
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.
Melia G, Seilles A, Tallon G. Évaluation d'un jeu sérieux thérapeutique. 2025; 4.
Siegrist M. Test-Retest Reliability of Different Versions of the Stroop Test. J Psychol. 1997; 131: 299-306.

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Responsible Party: Joel Belmin, Professor, RIVAGES
ClinicalTrials.gov Identifier: NCT04134988    
Other Study ID Numbers: MEDIMOOV_01
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joel Belmin, RIVAGES:
Fall
Older adults
Fear of falling
Serious games
Technology
Randomized controlled trial