Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fear of Falling and Risk of Falling
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|ClinicalTrials.gov Identifier: NCT04134988|
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : December 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Falls (Accidents) in Old Age||Other: Medimoov Other: Standard psychomotor therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Bi-weekly 35-minute sessions of an adaptated physical activity administered by a psychomotor therapist for 8 weeks.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134988
|Contact: Nolwenn Lapierre, PhDfirstname.lastname@example.org|
|Contact: Joël Belmin, MD, PhDemail@example.com|
|Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université||Recruiting|
|Ivry-sur-Seine, Val De Marne, France, 94200|
|Contact: Nolwenn Lapierre, PhD +33766673212 firstname.lastname@example.org|
|Contact: joël Belmin, MD, PhD +149594565 email@example.com|
|Principal Investigator:||Joël Belmin, MD, PhD||RIVAGES|