Osteogenesis ImperfectaNCT02542540
Effects of a Physical Rehabilitation Program Using the Nintendo Wii on Children With Osteogenesis Imperfecta (OI)
A study testing Training with Nintendo Wii console in people with Osteogenesis Imperfecta, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Training with Nintendo Wii console
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Training with Nintendo Wii console
- Keywords
- Osteogenesis Imperfecta, physical exercise training, Wii, muscular strength
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with Nintendo Wii consoleOther
Children with OI and draining for 3 months using Nintendo Wii console
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Training with Nintendo Wii console |
| Children with OI without training | No intervention | No training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline to 3 months
Secondary outcomes (16)
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
Measured: From baseline to 9 months
Compare physical inactivity between training group and control group
Physical inactivity will be assessed by the Physical Activity Questionnaire (Q-APS)
Measured: Month 3
Compare physical inactivity between training group and control group
Physical inactivity will be assessed by the Physical Activity Questionnaire (Q-APS)
Measured: Month 9
Compare functional benefit between training group and control group
The functional benefit will be evaluated by the Functional Independence Measure (FIM)
Measured: Month 3
Compare functional benefit between training group and control group
The functional benefit will be evaluated by the Functional Independence Measure (FIM)
Measured: Month 9
Compare body fat between training group and control group
Body fat composition will be determined by skinfold measurements
Measured: Month 3
Compare body fat between training group and control group
Body fat composition will be determined by skinfold measurements
Measured: Month 9
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)
Measured: Month 3
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)
Measured: Month 9
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"
Measured: Month 3
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"
Measured: Month 9
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
Measured: Month 3
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
Measured: Month 9
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
Measured: Month 3
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
Measured: Month 9
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
Measured: Baseline from 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: difficulty to include patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Sponsor
- Investigators
- Vincent Gautheron, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542540
- Sponsor's protocol ID
- 1201174
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02542540
- Acronym / sponsor ID
- 1201174
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Osteogenesis Imperfecta, physical exercise training, Wii, muscular strength
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty to include patients
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OI Children training with Nintendo Wii console | Experimental | Other: Training with Nintendo Wii consoleTraining for 3 months using the Nintendo Wii console on physical capacity in a group of children with Osteogenesis Imperfecta |
| Children with OI without training | No intervention | –No training |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- - 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;
Key exclusion criteria (7 listed)
- - 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training with Nintendo Wii consoleChildren with OI and draining for 3 months using Nintendo Wii console | Other | OI Children training with Nintendo Wii console |
Primary outcome
Change in physical capacity
Time frame: from baseline to 3 months
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
16 secondary outcomes
Change in physical capacity
Time frame: From baseline to 9 months
Compare physical inactivity between training group and control group
Time frame: Month 3
Compare physical inactivity between training group and control group
Time frame: Month 9
Compare functional benefit between training group and control group
Time frame: Month 3
Compare functional benefit between training group and control group
Time frame: Month 9
Compare body fat between training group and control group
Time frame: Month 3
Compare body fat between training group and control group
Time frame: Month 9
Compare quality of life between training group and control group
Time frame: Month 3
Compare quality of life between training group and control group
Time frame: Month 9
Compare muscle strength between training group and control group
Time frame: Month 3
Compare muscle strength between training group and control group
Time frame: Month 9
Compare endurance of lower limbs between training group and control group
Time frame: Month 3
Compare endurance of lower limbs between training group and control group
Time frame: Month 9
Compare Energy expenditure of lower limbs between training group and control group
Time frame: Month 3
Compare Energy expenditure of lower limbs between training group and control group
Time frame: Month 9
Training tolerance
Time frame: Baseline from 9 months
Results and safety
The study was stopped early (reason given: difficulty to include patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Gautheron, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with Nintendo Wii console in people with Osteogenesis Imperfecta, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty to include patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical capacity (time frame: from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.