NCT02134704

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

May 5, 2014

Last Update Submit

August 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Relative rotations of the bi-acromial line, thoracic and pelvic plan.

    2 hours

  • Walking speed, step length and single stance time.

    2 hours

  • The surface of displacement of the center of plantar pressure, static relative orientation of the bi-acromial line, thoracic and pelvic plan.

    2 hours

Study Arms (2)

Scoliosis Group

EXPERIMENTAL
Other: Data recording with all sensors

Healthy Volunteers Group

EXPERIMENTAL
Other: Data recording with all sensors

Interventions

The sensors will be placed in the child body and will allow the collection of all the data of the trial.

Healthy Volunteers GroupScoliosis Group

Eligibility Criteria

Age9 Years - 16 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Émilie Chipon

Grenoble, Isère, 38043, France

Location

Related Links

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Aurelien Courvoisier, Pr

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 9, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations