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

December 17, 2019 updated by: Joel Belmin

Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fall Apprehension and Risk: A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val De Marne
      • Ivry-sur-Seine, Val De Marne, France, 94200
        • Recruiting
        • Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before, at mid-term (Week 4) and at the end of the program (Week 8).
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.
Before, at mid-term (Week 4) and at the end of the program (Week 8).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before, at mid-term (Week 4) and at the end of the program (Week 8)
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.
Before, at mid-term (Week 4) and at the end of the program (Week 8)
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.
Before, at mid-term (Week 4) and at the end of the program (Week 8)
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.
Before, at mid-term (Week 4) and at the end of the program (Week 8)
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.
At the end of the program (Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joel Belmin

Investigators

  • Principal Investigator: Joël Belmin, MD, PhD, RIVAGES

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 9, 2019

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (ACTUAL)

October 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MEDIMOOV_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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