TerminatedNot Applicable

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

Stopped: difficulty to include patients

France20 participantsStarted 2013-07

Plain-language 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.

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in physical capacity

Timeframe: from baseline to 3 months

Trial details

NCT IDNCT02542540

SponsorCentre Hospitalier Universitaire de Saint Etienne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Osteogenesis Imperfecta trials