Effect of Spinal Surgery on the Posture and the Balance of the Patients Reached of Spinal Pathologies

August 26, 2019 updated by: Groupe Hospitalier Paris Saint Joseph

Effect of Spinal Surgery on Stable Force Platform Parameters Estimating the Posture and the Balance of the Patients Reached of Spinal Pathologies

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At the inclusion, Day 1 and day 2 after surgery, the patient will stand on the stabilometric platform, with arms extended along the body, barefoot at 30 ° with a 2 cm gap at the heels.

He will fix a target located 1 meter away from him, in silence and will be instructed to "stand as still as possible, with his arms along his body, look in the direction of the visual target, do not think about anything. ". Then there will be a collection of data in 3 shots of 90 seconds, with a rest period between each shot, using the Winposture® software. The patient will answer health related quality of life questionnaires.

6 months after inclusion, patients will answer health related quality of life questionnaires.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Paris Saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Use of stable force platform
Ennrollment of every patient programmed for spinal surgery in orthopaedic service
Diagnostic test: Use of stable force platform
Use of stable force platform to appreciate the posture before and after spinal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center of foot pressure (COP) positions
Time Frame: Day 1- Day 2
COP measurements by using stable force platform
Day 1- Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Study Director: Romain Clquin, Groupe Hospitalier Paris St Joseph
  • Principal Investigator: Stéphane WOLFF, MD, Groupe Hospitalier Paris St Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Actual)

July 18, 2017

Study Completion (Actual)

August 26, 2019

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • STABILOMETRIE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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