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

NCT ID: NCT02542540

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Osteogenesis Imperfecta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Training with Nintendo Wii console

Intervention Type: OTHER

Children with OI and draining for 3 months using Nintendo Wii console

Children with OI without training

No training

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Training with Nintendo Wii console

Children with OI and draining for 3 months using Nintendo Wii console

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation de France

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Gautheron, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

1201174

Identifier Type: -

Identifier Source: org_study_id