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MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis (MOUVSCO)

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ClinicalTrials.gov Identifier: NCT02134704
Recruitment Status : Terminated (All patients were recruted but it has been difficulte to recrute all volunteers (15/30) . However data should be sufficient for analyse of data.)
First Posted : May 9, 2014
Last Update Posted : August 30, 2016
Sponsor:
Collaborators:
TIMC-IMAG
Clinical Investigation Centre for Innovative Technology Network
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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.

The aim of this study is the detailed analysis of postural anomalies in moderate scoliosis patients compared with healthy volunteers


Condition or disease Intervention/treatment Phase
Scoliosis Other: Data recording with all sensors Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Experimental: Scoliosis Group Other: Data recording with all sensors
The sensors will be placed in the child body and will allow the collection of all the data of the trial.

Experimental: Healthy Volunteers Group Other: Data recording with all sensors
The sensors will be placed in the child body and will allow the collection of all the data of the trial.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Relative rotations of the bi-acromial line, thoracic and pelvic plan. [ Time Frame: 2 hours ]
    • 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.

  2. Walking speed, step length and single stance time. [ Time Frame: 2 hours ]
    Assess the performance of walking in scoliosis patients.

  3. 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 ]
    Assess balance and static posture of scoliotic patients.



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Ages Eligible for Study:   9 Years to 16 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Scoliosis Group - Inclusion Criteria:

  • female children patients from 9 to 16 years old,
  • patients with idiopathic scoliosis lumbar left and / or right thoracic,
  • patients with moderate scoliosis: Cobb angle measured on a radiograph between 10 ° and 25°,
  • both parents of patients must be affiliated to social security or similarly regime.

Healthy Volunteers Group - Inclusion Criteria:

  • female children from 9 to 16 years old, matched in age and size with scoliosis patients,
  • children with no neuromuscular disease that may have an influence on the required tasks,
  • both parents of children must be affiliated to social security or similarly regime,

Exclusion Criteria:

  • refusal to consent: from child's in age to consent or from both parents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134704


Locations
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France
Émilie Chipon
Grenoble, Isère, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
TIMC-IMAG
Clinical Investigation Centre for Innovative Technology Network
Investigators
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Principal Investigator: Aurelien Courvoisier, Pr University Hospital, Grenoble
Additional Information:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02134704    
Other Study ID Numbers: MOUVSCO-DCIC-1411
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases