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

Osteogenesis Imperfecta Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02542540
• Other study ID #: 1201174
• Status: Terminated
• Phase: N/A
• First received: September 3, 2015
• Last updated: January 19, 2016
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

Other:
• Training with Nintendo Wii console
Children with OI and draining for 3 months using Nintendo Wii console

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Compare physical inactivity between training group and control group	Physical inactivity will be assessed by the Physical Activity Questionnaire (Q-APS)	Month 3	No
Secondary	Compare physical inactivity between training group and control group	Physical inactivity will be assessed by the Physical Activity Questionnaire (Q-APS)	Month 9	No
Secondary	Compare functional benefit between training group and control group	The functional benefit will be evaluated by the Functional Independence Measure (FIM)	Month 3	No
Secondary	Compare functional benefit between training group and control group	The functional benefit will be evaluated by the Functional Independence Measure (FIM)	Month 9	No
Secondary	Compare body fat between training group and control group	Body fat composition will be determined by skinfold measurements	Month 3	No
Secondary	Compare body fat between training group and control group	Body fat composition will be determined by skinfold measurements	Month 9	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No