Spinal SurgeryNCT03069794
Effect of Spinal Surgery on the Posture and the Balance of the Patients Reached of Spinal Pathologies
A study testing Use of stable force platform in people with Spinal Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Surgery
- What is being tested?
- Use of stable force platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2017to 26 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years old
- Patient programmed for spinal surgery
- Patient accepting participation
Who cannot join
- Refusal of participation
- All patient with vestibular disease
- All patient with neurologic disease
- Patient with pathologies not allowing to maintain the prolonged standing.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: 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 .
Read the 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.
- Conditions
- Spinal Surgery
- Being tested
- Use of stable force platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of stable force platformDiagnostic test
Use of stable force platform to appreciate the posture before and after spinal surgery
| Study group | Role | What they receive |
|---|---|---|
| Use of stable force platform | Other | Ennrollment of every patient programmed for spinal surgery in orthopaedic service Receives: Diagnostic Test: Use of stable force platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of foot pressure (COP) positions
COP measurements by using stable force platform
Measured: Day 1- Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start28 Mar 2017
- Primary completion18 Jul 2017
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain Clquin, Study director, Groupe Hospitalier Paris St JosephStéphane WOLFF, MD, Principal investigator, Groupe Hospitalier Paris St Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069794
- Sponsor's protocol ID
- STABILOMETRIE
- Status last verified
- Aug 2019
- First submitted
- 28 Feb 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spinal Surgery on Stable Force Platform Parameters Estimating the Posture and the Balance of the Patients Reached of Spinal Pathologies
- ClinicalTrials.gov ID
- NCT03069794
- Acronym / sponsor ID
- STABILOMETRIE
- Conditions
- Spinal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of stable force platform | Other | Diagnostic Test: Use of stable force platformEnnrollment of every patient programmed for spinal surgery in orthopaedic service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age> 18 years old
- Patient programmed for spinal surgery
- Patient accepting participation
Key exclusion criteria (4 listed)
- Refusal of participation
- All patient with vestibular disease
- All patient with neurologic disease
- Patient with pathologies not allowing to maintain the prolonged standing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of stable force platformUse of stable force platform to appreciate the posture before and after spinal surgery | Diagnostic test | Use of stable force platform |
Primary outcome
Center of foot pressure (COP) positions
Time frame: Day 1- Day 2
COP measurements by using stable force platform
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain Clquin study director
Groupe Hospitalier Paris St Joseph
Stéphane WOLFF, MD principal investigator
Groupe Hospitalier Paris St Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of stable force platform in people with Spinal Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of foot pressure (COP) positions (time frame: Day 1- Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.