Clinical trial NCT02542540: Effects of a Physical Rehabilitation Program Using the Nintendo Wii on Children With Osteogenesis Imperfecta (OI)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteogenesis Imperfecta
Keywords: Osteogenesis Imperfecta
physical exercise training
Wii
muscular strength
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2015-09-07
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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.

Primary outcomes:
measure: Change in physical capacity
timeFrame: from baseline to 3 months
Secondary outcomes:
measure: Change in physical capacity
timeFrame: From baseline to 9 months
measure: Compare physical inactivity between training group and control group
timeFrame: Month 3
measure: Compare physical inactivity between training group and control group
timeFrame: Month 9
measure: Compare functional benefit between training group and control group
timeFrame: Month 3
measure: Compare functional benefit between training group and control group
timeFrame: Month 9
measure: Compare body fat between training group and control group
timeFrame: Month 3
measure: Compare body fat between training group and control group
timeFrame: Month 9
measure: Compare quality of life between training group and control group
timeFrame: Month 3
measure: Compare quality of life between training group and control group
timeFrame: Month 9
measure: Compare muscle strength between training group and control group
timeFrame: Month 3
measure: Compare muscle strength between training group and control group
timeFrame: Month 9
measure: Compare endurance of lower limbs between training group and control group
timeFrame: Month 3
measure: Compare endurance of lower limbs between training group and control group
timeFrame: Month 9
measure: Compare Energy expenditure of lower limbs between training group and control group
timeFrame: Month 3
measure: Compare Energy expenditure of lower limbs between training group and control group
timeFrame: Month 9
measure: Training tolerance
timeFrame: Baseline from 9 months
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Vincent Gautheron, PhD
role: PRINCIPAL_INVESTIGATOR
References: