NCT02542540

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

September 3, 2015

Last Update Submit

January 19, 2016

Conditions

Osteogenesis Imperfecta

Keywords

Osteogenesis Imperfectaphysical exercise trainingWiimuscular strength

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Change in physical capacity

    From baseline to 9 months

  • Compare physical inactivity between training group and control group

    Month 3

  • Compare physical inactivity between training group and control group

    Month 9

  • Compare functional benefit between training group and control group

    Month 3

  • Compare functional benefit between training group and control group

    Month 9

  • +11 more secondary outcomes

Study Arms (2)

OI Children training with Nintendo Wii console

EXPERIMENTAL

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

Children with OI without training

NO INTERVENTION

No training

Interventions

Training with Nintendo Wii consoleOTHER

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

OI Children training with Nintendo Wii console

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Vincent Gautheron, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 7, 2015

Study Start

July 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 20, 2016

Record last verified: 2015-09

Locations

FR(1)