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

Not Applicable

• Conditions: Falls (Accidents) in Old Age
• Interventions: Other: Medimoov; Other: Standard psychomotor therapy

• Registration Number: NCT04134988
• Lead Sponsor: Joel Belmin

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.

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-22
• Status Verified: 2019-12
• Study Start: 2019-12-09
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-19
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medimoov	Medimoov	Bi-weekly 35-minute sessions of an adaptated physical activity administered by a psychomotor therapist for 8 weeks.
Standard rehabilitation	Standard psychomotor therapy	Bi-weekly 35-minute sessions of the standard psychomotor therapy for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in the Fall Efficacy Scale-International (FES-I)	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 Score Physical Performance Battery	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Trail Making Test A and B	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 Victoria Stroop test	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 One-Leg Stand test	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.
Change in the Timed Up And Go	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.
Satisfaction questionnaire	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.

Trial Locations

Locations (1)

Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université; 🇫🇷 Ivry-sur-Seine, Val De Marne, France