NCT03069794

Brief Summary

Many studies are in favour of the importance of the rachis on the postural balance of the body.It is possible to study the upright posture by determining the center of pressure using a platform of strength.The spinal surgery have two objectives ,mechanic and neurologic .By deformation correction and stabilizing vertebral stages via arthrodesis, it seems to hypothesize that surgery can modify postural balance. This study aim to evaluate spinal surgery effect on posture using that plaftorm .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

March 28, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

February 28, 2017

Last Update Submit

August 26, 2019

Conditions

Spinal Surgery

Outcome Measures

Primary Outcomes (1)

  • Center of foot pressure (COP) positions

    COP measurements by using stable force platform

    Day 1- Day 2

Study Arms (1)

Use of stable force platform

OTHER

Ennrollment of every patient programmed for spinal surgery in orthopaedic service

Diagnostic Test: Use of stable force platform

Interventions

Use of stable force platformDIAGNOSTIC_TEST

Use of stable force platform to appreciate the posture before and after spinal surgery

Use of stable force platform

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> 18 years old
  • Patient programmed for spinal surgery
  • Patient accepting participation

You may not qualify if:

  • Refusal of participation
  • All patient with vestibular disease
  • All patient with neurologic disease
  • Patient with pathologies not allowing to maintain the prolonged standing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • Romain Clquin

    Groupe Hospitalier Paris St Joseph

    STUDY DIRECTOR

  • Stéphane WOLFF, MD

    Groupe Hospitalier Paris St Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

March 28, 2017

Primary Completion

July 18, 2017

Study Completion

August 26, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

FR(1)