ScoliosisMOUVSCONCT02134704
MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
A study testing Data recording with all sensors in people with Scoliosis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The hypothesis of this study is that moderate scoliosis patients have postural and kinematic differences (static and dynamic) compared with healthy volunteers and it is possible to characterize and quantify. Read more about this study
- Who is it for?
- Ages 9 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- Data recording with all sensors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Jun 2016
- 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 9 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- refusal to consent: from child's in age to consent or from both parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
The hypothesis of this study is that moderate scoliosis patients have postural and kinematic differences (static and dynamic) compared with healthy volunteers and it is possible to characterize and quantify.
The aim of this study is the detailed analysis of postural anomalies in moderate scoliosis patients compared with healthy volunteers
Read the detailed description
Subjects participating in the study must wear sensors that will be arrange at the shoulders, spine, pelvis and legs. Subjects will perform under the direction of the investigator, different tasks of a total duration of 45 minutes.
During the period of experimentation, the data collected will be:
- the positions of each one of the sensors in all three planes of space,
- the ground support forces
- Conditions
- Scoliosis
- Being tested
- Data recording with all sensors
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data recording with all sensorsOther
The sensors will be placed in the child body and will allow the collection of all the data of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis Group | Experimental | Not described Receives: Other: Data recording with all sensors |
| Healthy Volunteers Group | Experimental | Not described Receives: Other: Data recording with all sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative movements, in mm, of the spinous processes in the three planes of space
Characterize the kinematic anomalies in scoliosis patients compared with healthy volunteers during typical tasks of trunk flexion.
Measured: 2 hours
Secondary outcomes (3)
Relative rotations of the bi-acromial line, thoracic and pelvic plan.
- Assess the existence of kinematic differences between the scoliosis patients and healthy volunteers during forward bending.
- Assess the kinematic differences between the scoliosis patients and healthy volunteers when they sit and up from a stool.
- Assess the kinematic differences between the scoliosis patients and healthy volunteers during walking.
Measured: 2 hours
Walking speed, step length and single stance time.
Assess the performance of walking in scoliosis patients.
Measured: 2 hours
The surface of displacement of the center of plantar pressure, static relative orientation of the bi-acromial line, thoracic and pelvic plan.
Assess balance and static posture of scoliotic patients.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: All patients were recruted but it has been difficulte to recrute all volunteers (15/30) . However data should be sufficient for analyse of data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Aurelien Courvoisier, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134704
- Sponsor's protocol ID
- MOUVSCO-DCIC-1411
- Acronym
- MOUVSCO
- Status last verified
- Aug 2016
- First submitted
- 5 May 2014
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
- ClinicalTrials.gov ID
- NCT02134704
- Acronym / sponsor ID
- MOUVSCO / MOUVSCO-DCIC-1411
- Conditions
- Scoliosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All patients were recruted but it has been difficulte to recrute all volunteers (15/30) . However data should be sufficient for analyse of data.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 May 2014 (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.
The hypothesis of this study is that moderate scoliosis patients have postural and kinematic differences (static and dynamic) compared with healthy volunteers and it is possible to characterize and quantify.
The aim of this study is the detailed analysis of postural anomalies in moderate scoliosis patients compared with healthy volunteers
Detailed description
Subjects participating in the study must wear sensors that will be arrange at the shoulders, spine, pelvis and legs. Subjects will perform under the direction of the investigator, different tasks of a total duration of 45 minutes.
During the period of experimentation, the data collected will be:
- the positions of each one of the sensors in all three planes of space,
- the ground support forces
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoliosis Group | Experimental | Other: Data recording with all sensors |
| Healthy Volunteers Group | Experimental | Other: Data recording with all sensors |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- refusal to consent: from child's in age to consent or from both parents
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 |
|---|---|---|
| Data recording with all sensorsThe sensors will be placed in the child body and will allow the collection of all the data of the trial. | Other | Healthy Volunteers Group, Scoliosis Group |
Primary outcome
Relative movements, in mm, of the spinous processes in the three planes of space
Time frame: 2 hours
Characterize the kinematic anomalies in scoliosis patients compared with healthy volunteers during typical tasks of trunk flexion.
3 secondary outcomes
Relative rotations of the bi-acromial line, thoracic and pelvic plan.
Time frame: 2 hours
Walking speed, step length and single stance time.
Time frame: 2 hours
The surface of displacement of the center of plantar pressure, static relative orientation of the bi-acromial line, thoracic and pelvic plan.
Time frame: 2 hours
Results and safety
The study was stopped early (reason given: All patients were recruted but it has been difficulte to recrute all volunteers (15/30) . However data should be sufficient for analyse of data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Website of the Grenoble clinical investigation center - Technological InnovationLink provided by the sponsor.
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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.
Aurelien Courvoisier, Pr principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data recording with all sensors in people with Scoliosis, run by University Hospital, Grenoble 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 0 inclusion and 1 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 30 Aug 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: All patients were recruted but it has been difficulte to recrute all volunteers (15/30) . However data should be sufficient for analyse of data.). 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?
Relative movements, in mm, of the spinous processes in the three planes of space (time frame: 2 hours). 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 30 Aug 2016.