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

Scoliosis Clinical Trial

— MOUVSCO  

Official title:

Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02134704
• Other study ID #: MOUVSCO-DCIC-1411
• Status: Terminated
• Phase: N/A
• First received: May 5, 2014
• Last updated: August 29, 2016
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 16 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
France	Émilie Chipon	Grenoble	Isère

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network, TIMC-IMAG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Walking speed, step length and single stance time.	Assess the performance of walking in scoliosis patients.	2 hours	No
Secondary	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	No

External Links

•   Website of the Grenoble clinical investigation center - Technological Innovation