Clinical Trial: Effects of a Physical Rehabilitation Program Using the Nintendo Wii on Children With Osteogenesis Imperfecta (OI)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Effects of a Physical Rehabilitation Program Using the Nintendo Wii on Children With Osteogenesis Imperfecta (OI) Is Nintendo Wii an Effective Intervention for Children Wi

Brief Summary:

Children with osteogenesis imperfecta are described as extremely sedentary and therefore fatigable, which strongly impacts their daily activities. The physical rehabilitation of these children is a fundamental aspect of treatment.

It has been shown that playing Wii console causes the same increase in energy expenditure than practicing moderate exercise, while ensuring user safety. This type of physical exercise with this type of fun game console might have a role in the treatment of OI children on the physical side but also on the psychological side.


Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Current Primary Outcome: Change in physical capacity [ Time Frame: from baseline to 3 months ]

Compare the change in physical capacity between training group of children with OI and control group of children with OI. The physical capacity is measured by maximal oxygen consumption VO2 max (ml/min/kg) measured during incremental exercise on cycle ergometer


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in physical capacity [ Time Frame: From baseline to 9 months ]
    Compare the change in physical capacity between training group of children with OI and control group of children with OI. The physical capacity is measured by maximal oxygen consumption VO2 max (ml/min/kg) measured during incremental exercise on cycle ergometer
  • Compare physical inactivity between training group and control group [ Time Frame: Month 3 ]
    Physical inactivity will be assessed by the Physical Activity Questionnaire (Q-APS)
  • Compare physical inactivity between training group and control group [ Time Frame: Month 9 ]
    Physical inactivity will be assessed by the Physical Activity Questionnaire (Q-APS)
  • Compare functional benefit between training group and control group [ Time Frame: Month 3 ]
    The functional benefit will be evaluated by the Functional Independence Measure (FIM)
  • Compare functional benefit between training group and control group [ Time Frame: Month 9 ]
    The functional benefit will be evaluated by the Functional Independence Measure (FIM)
  • Compare body fat between training group and control group [ Time Frame: Month 3 ]
    Body fat composition will be determined by skinfold measurements
  • Compare body fat between training group and control group [ Time Frame: Month 9 ]
    Body fat composition will be determined by skinfold measurements
  • Compare quality of life between training group and control group [ Time Frame: Month 3 ]
    The quality of life will be determined the Index Questionnaire Reintegration to Normal Life (IRVN)
  • Compare quality of life between training group and control group [ Time Frame: Month 9 ]
    The quality of life will be determined the Index Questionnaire Reintegration to Normal Life (IRVN)
  • Compare muscle strength between training group and control group [ Time Frame: Month 3 ]

    The muscle strength is a composite outcome. It will be assessed by:

    • The grip strength (force applied by the hand)
    • The maximal quadriceps muscle strength will be measured using an isokinetic dynamometer "Contrex"
  • Compare muscle strength between training group and control group [ Time Frame: Month 9 ]

    The muscle strength is a composite outcome. It will be assessed by:

    • The grip strength (force applied by the hand)
    • The maximal quadriceps muscle strength will be measured using an isokinetic dynamometer "Contrex"
  • Compare endurance of lower limbs between training group and control group [ Time Frame: Month 3 ]
    The endurance of the lower limbs will be measured by EMG analysis on incremental torque repetitive exercise
  • Compare endurance of lower limbs between training group and control group [ Time Frame: Month 9 ]
    The endurance of the lower limbs will be measured by EMG analysis on incremental torque repetitive exercise
  • Compare Energy expenditure of lower limbs between training group and control group [ Time Frame: Month 3 ]
    Energy expenditure is a composite outcome. It will be measured by collecting the respiratory exchange and heart rate during endurance, tennis and boxing games using the Nintendo WII
  • Compare Energy expenditure of lower limbs between training group and control group [ Time Frame: Month 9 ]
    Energy expenditure is a composite outcome. It will be measured by collecting the respiratory exchange and heart rate during endurance, tennis and boxing games using the Nintendo WII
  • Training tolerance [ Time Frame: Baseline from 9 months ]

    Reentrainment tolerance is a composite outcome. It will be assessed by :

    • collecting any events related to WII training or any events related to everyday life (fractures, pain,etc.)
    • dropout rate study report


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Saint Etienne

Dates:
Date Received: September 3, 2015
Date Started: July 2013
Date Completion:
Last Updated: January 19, 2016
Last Verified: September 2015