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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03069794
Other study ID # STABILOMETRIE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 28, 2017
Est. completion date August 26, 2019

Study information

Verified date August 2019
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date August 26, 2019
Est. primary completion date July 18, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center of foot pressure (COP) positions COP measurements by using stable force platform Day 1- Day 2
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