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Are Serious Games Promoting Mobility an Attractive Alternative to Conventional Self-training for Elderly People?

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ClinicalTrials.gov Identifier: NCT02077049
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
State Secretariat for Education Research and Innovation, Switzerland
Office Ambient Assisted Living
Information provided by (Responsible Party):
Dr. Peter Oesch, Klinik Valens

Brief Summary:

The main objective of this study is to determine whether elderly people in rehabilitation setting show higher adherence to self-training when using computer-based-learning games (i.e. the so called serious games) than when performing conventional exercises. Secondly the study explores to which extend balance and mobility performances vary according to the mode of self-training.

The primary study hypothesis is that elderly people practice longer and more frequently with serious games than with a conventional exercise booklet. The secondary hypothesis is that patients experience a significant higher improvement in their balance capacity by using serious games compared to patients performing conventional exercises.


Condition or disease Intervention/treatment Phase
Mobility Limitations Geriatric Disorder Device: serious games Other: Conventional self-training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Are Serious Games Promoting Mobility an Attractive Alternative to Conventional Self-training for Elderly People? A Randomized Controlled Trial.
Study Start Date : February 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: serious games self-training program
Serious games are played, using Kinect® and Fit Bit®. This program is performed during the 10 days of the intervention on a self-training basis and 2 specific time-slot (2x30 min) per day are allocated for this program.
Device: serious games

Execution of computer-based games that stimulate patient's mobility. The game is displayed on a Television (TV) screen and the patient's movements are detected by the sensors of the Kinect® camera, requiring therefore no game console.

The Fit Bit®, a mobility tracker device, is attached at the patient's belt the whole day and measure all the trips performed and stairs climbed.

This serious games program is instructed individually by experienced physiotherapists.

Other Names:
  • Kinect®
  • Xbox®
  • Windows®
  • Fit Bit®

Active Comparator: Conventional self-training program
conventional physical exercises are performed during the 10 days of the intervention, on a self-training basis and 2 specific time-slot (2x30 min) per day are allocated for this program.
Other: Conventional self-training
Participants perform conventional physical exercises that train their balance capabilities. There are instructed by experienced physiotherapists and are adapted to each patient's physical abilities. Detailed handouts are distributed to each participants.
Other Names:
  • gymnastic exercises
  • home exercises
  • physical exercises




Primary Outcome Measures :
  1. Intensity of self-training [ Time Frame: The intensity of self-training is recorded every day and thus from the begining (t1) till the end (t2) of the intervention phase ie. during 10 working days. ]

    Self-training intensity is defined as the frequency of training sessions (f) multiplied by the duration (T) of each training session. The training intensity (f x T) of the 10-days intervention are summated.

    These data are recorded daily in a logbook by the patient himself from t1 (which equates to approximately day 4 after admission) till the end of the intervention (t2) i.e. 10 workings days later. The logbook is then collected for data extraction at the end of the intervention (t2), which equates to approximately day 16-17 after patient's admission in the clinic.



Secondary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: The test is performed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days ]

    The intervention lasts 10 working days (from t1 to t2), starting from day 4 of the patient's admission in the rehabilitation center.

    The Berg Balance Scale is a clinical test for static and dynamic balance abilities. It is assessed before the start of the intervention (t1), i.e. approximately at day 1-2 after admission and again at the end of the intervention phase (t2) 10 working days later, i.e. approximately at day 16-17 after admission.


  2. Falls Efficacy Scale - International version [ Time Frame: The questionnaire is completed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days ]

    The intervention phase lasts 10 working days (from t1 to t2), starting from day 4 of the patient's admission in the rehabilitation center.

    The Falls Efficacy Scale is a questionnaire measuring the fear of falling. It is assessed before the start of the intervention (t1), i.e. approximately at day 1-2 after admission and again at the end of the intervention phase (t2) 10 working days later, i.e. approximately at day 16-17 after admission.


  3. Local dynamic stability [ Time Frame: The test is performed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days. ]
    Local Dynamic Stability (LDS), a non-linear gait stability index, has been advocated as an early indicator of risk for falls. LDS is measured with a tri-axial accelerometer and quantified by calculating Lyapunov exponent.



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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:

  1. +65 years old
  2. Ability to walk independently over 20meters, with or without walking aids.
  3. Self-training prescribed by the doctor
  4. sufficient written and spoken knowledge of German to fill out questionnaires, with or without help.
  5. Informed consent

Exclusion Criteria:

  1. Cognitive impairment, defined as a Mini-Mental-State Examination (MMSE) score < 26.
  2. Other limiting disorders hampering the practice of computer-based games (e.g. visual impairment, numbness, vertigo)

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): NCT02077049


Locations
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Switzerland
Walenstadtberg Klinik
Walenstadtberg, Saint Gallen, Switzerland, 8881
Sponsors and Collaborators
Klinik Valens
State Secretariat for Education Research and Innovation, Switzerland
Office Ambient Assisted Living
Investigators
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Principal Investigator: Peter Oesch, PhD PT Kliniken Valens

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Peter Oesch, PhD PT, Klinik Valens
ClinicalTrials.gov Identifier: NCT02077049     History of Changes
Other Study ID Numbers: KlinikenValens_Oesch_RCT-2013
EKSG 13/081/1B ( Other Identifier: Cantonal Ethics Committee St.Gallen )
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Keywords provided by Dr. Peter Oesch, Klinik Valens:
elderly
exercise program
self-training
mobility
computer-based learning games
serious game
balance
training adherence
training compliance
Kinect ®
Fit Bit ®
Additional relevant MeSH terms:
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Mobility Limitation
Signs and Symptoms