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

Primary Purpose

Scoliosis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Data recording with all sensors
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Scoliosis

Eligibility Criteria

9 Years - 16 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Émilie Chipon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Scoliosis Group

Healthy Volunteers Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Walking speed, step length and single stance time.
Assess the performance of walking in scoliosis patients.
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.

Full Information

First Posted
May 5, 2014
Last Updated
August 29, 2016
Sponsor
University Hospital, Grenoble
Collaborators
TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network
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1. Study Identification

Unique Protocol Identification Number
NCT02134704
Brief Title
MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
Acronym
MOUVSCO
Official Title
Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scoliosis Group
Arm Type
Experimental
Arm Title
Healthy Volunteers Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Data recording with all sensors
Intervention Description
The sensors will be placed in the child body and will allow the collection of all the data of the trial.
Primary Outcome Measure Information:
Title
Relative movements, in mm, of the spinous processes in the three planes of space
Description
Characterize the kinematic anomalies in scoliosis patients compared with healthy volunteers during typical tasks of trunk flexion.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Relative rotations of the bi-acromial line, thoracic and pelvic plan.
Description
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.
Time Frame
2 hours
Title
Walking speed, step length and single stance time.
Description
Assess the performance of walking in scoliosis patients.
Time Frame
2 hours
Title
The surface of displacement of the center of plantar pressure, static relative orientation of the bi-acromial line, thoracic and pelvic plan.
Description
Assess balance and static posture of scoliotic patients.
Time Frame
2 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurelien Courvoisier, Pr
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Émilie Chipon
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.cic-it-grenoble.fr/
Description
Website of the Grenoble clinical investigation center - Technological Innovation

Learn more about this trial

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

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