Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 95 of 154 for:    "Skeletal Dysplasias"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02542540
Recruitment Status : Terminated (difficulty to include patients)
First Posted : September 7, 2015
Last Update Posted : January 20, 2016
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Osteogenesis Imperfecta Other: Training with Nintendo Wii console Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 With Osteogenesis Imperfecta
Study Start Date : July 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: OI Children training with Nintendo Wii console
Training for 3 months using the Nintendo Wii console on physical capacity in a group of children with Osteogenesis Imperfecta
Other: Training with Nintendo Wii console
Children with OI and draining for 3 months using Nintendo Wii console

No Intervention: Children with OI without training
No training



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Compare body fat between training group and control group [ Time Frame: Month 3 ]
    Body fat composition will be determined by skinfold measurements

  7. Compare body fat between training group and control group [ Time Frame: Month 9 ]
    Body fat composition will be determined by skinfold measurements

  8. 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)

  9. 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)

  10. 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"

  11. 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"

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Children affiliated to a social security scheme
  • Children diagnosed OI by a competent physician of one of the French specialist centers;
  • OI children type 1 or type 4;
  • Stable OI (far from a fractional episode of at least two months);
  • Children without regular activity on the Nintendo Wii console or other interactive console;
  • Boy or Girl> 6 to 18 years
  • Parents or person having parental authority affiliated to a social security scheme
  • Parents or person having parental authority who signed the consent form for the study.

Exclusion Criteria:

  • - Children who can not walk;
  • Children with severe OI other than type 1 or type 4;
  • Fracture during the last two months;
  • Surgical intervention within the last 8 months;
  • Inability to understand and follow the protocol;
  • Participation in another clinical study;
  • Children, parents or holder of parental authority refusing the written consent.

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): NCT02542540


Locations
Layout table for location information
France
CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Fondation de France
Investigators
Layout table for investigator information
Principal Investigator: Vincent Gautheron, PhD CHU Saint-Etienne

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02542540     History of Changes
Other Study ID Numbers: 1201174
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: September 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Osteogenesis Imperfecta
physical exercise training
Wii
muscular strength

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteogenesis Imperfecta
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases