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

Not Applicable

Terminated

• Conditions: Scoliosis
• Interventions: Other: Data recording with all sensors

• Registration Number: NCT02134704
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Study Start: 2014-09
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers Group	Data recording with all sensors	-
Scoliosis Group	Data recording with all sensors	-

Primary Outcome Measures

Name	Time	Method
Relative movements, in mm, of the spinous processes in the three planes of space	2 hours	Characterize the kinematic anomalies in scoliosis patients compared with healthy volunteers during typical tasks of trunk flexion.

Secondary Outcome Measures

Name	Time	Method
Walking speed, step length and single stance time.	2 hours	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.	2 hours	Assess balance and static posture of scoliotic patients.
Relative rotations of the bi-acromial line, thoracic and pelvic plan.	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.

Trial Locations

Locations (1)

Émilie Chipon; 🇫🇷 Grenoble, Isère, France