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

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

Study Overview

• Status: Terminated
• Conditions: Scoliosis
• Intervention / Treatment: Other: Data recording with all sensors

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Isère
    • Grenoble, Isère, France, 38043
      • Émilie Chipon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours
Walking speed, step length and single stance time.	Assess the performance of walking in scoliosis patients.	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.	2 hours

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Clinical Investigation Centre for Innovative Technology Network; TIMC-IMAG
• Investigators: Principal Investigator: Aurelien Courvoisier, Pr, University Hospital, Grenoble

Publications and helpful links

Helpful Links

• Website of the Grenoble clinical investigation center - Technological Innovation

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Estimate): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: MOUVSCO-DCIC-1411