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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteogenesis Imperfecta

Intervention / Treatment
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* Other: Training with Nintendo Wii console


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OI Children training with Nintendo Wii console<br>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<br>* Children with OI and draining for 3 months using Nintendo Wii console<br>|
| No Intervention: Children with OI without training<br>No training | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical capacity | 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 | from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical capacity | 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 | From baseline to 9 months | 
| Compare physical inactivity between training group and control group | Physical inactivity will be assessed by the Physical Activity Questionnaire (Q-APS) | Month 3 | 
| Compare physical inactivity between training group and control group | Physical inactivity will be assessed by the Physical Activity Questionnaire (Q-APS) | Month 9 | 
| Compare functional benefit between training group and control group | The functional benefit will be evaluated by the Functional Independence Measure (FIM) | Month 3 | 
| Compare functional benefit between training group and control group | The functional benefit will be evaluated by the Functional Independence Measure (FIM) | Month 9 | 
| Compare body fat between training group and control group | Body fat composition will be determined by skinfold measurements | Month 3 | 
| Compare body fat between training group and control group | Body fat composition will be determined by skinfold measurements | Month 9 | 
| Compare quality of life between training group and control group | The quality of life will be determined the Index Questionnaire Reintegration to Normal Life (IRVN) | Month 3 | 
| Compare quality of life between training group and control group | The quality of life will be determined the Index Questionnaire Reintegration to Normal Life (IRVN) | Month 9 | 
| Compare muscle strength between training group and control group | 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 | Month 3 | 
| Compare muscle strength between training group and control group | 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 | Month 9 | 
| Compare endurance of lower limbs between training group and control group | The endurance of the lower limbs will be measured by EMG analysis on incremental torque repetitive exercise | Month 3 | 
| Compare endurance of lower limbs between training group and control group | The endurance of the lower limbs will be measured by EMG analysis on incremental torque repetitive exercise | Month 9 | 
| Compare Energy expenditure of lower limbs between training group and control group | 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 | Month 3 | 
| Compare Energy expenditure of lower limbs between training group and control group | 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 | Month 9 | 
| Training tolerance | 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 | Baseline from 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteogenesis Imperfecta, physical exercise training, Wii, muscular strength