Idiopathic ScoliosisLevPOSNCT06152601
Early Standing in Minors Operated on for Idiopathic Scoliosis
A study testing anticipated bipedal standing position in the immediate post-operative phase in people with Idiopathic Scoliosis and ERAS, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The implementation of an enhanced rehabilitation after surgery (ERAS) program in major orthopedic surgery and in scoliosis surgery in children and adolescents has become a marker of good practice. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Idiopathic Scoliosis, ERAS
- What is being tested?
- anticipated bipedal standing position in the immediate post-operative phase
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2024to 1 Mar 2025
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Programming of spinal surgery via the posterior approach for idiopathic scoliosis eligible for an ERAS program
- Person affiliated or beneficiary of a social security scheme
- Free, informed and written consent signed by the legal guardians of the minor patient
- Free and informed consent of the minor patient
Who cannot join
- Scoliosis linked to a neuromuscular pathology
- Physical status score of American Society of Anesthesiologists (ASA) > 2
- Severe or unbalanced associated conditions (cardiac, pulmonary, coagulopathy or anticoagulant treatment with curative intent, long-term corticosteroid therapy)
- Malnutrition
- Major cognitive disorders
- Impossibility for the parent(s) to contact the pediatrician or the hospital service if necessary (minor patients)
Show all 12Show fewer
- Pregnancy
- Feeding with milk
- Severe disability related to scoliosis with impossibility of ambulation
- Surgical assembly planned unstable or requiring the wearing of a corset
- Refusal of minor patient or of the legal guardians of the minor patient
- Patient under legal protection, guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Standing in Children and Adolescent Operated on for Idiopathic Scoliosis
The implementation of an enhanced rehabilitation after surgery (ERAS) program in major orthopedic surgery and in scoliosis surgery in children and adolescents has become a marker of good practice. Investigators are already applying anesthetic, surgical, peri-operative medicine and rehabilitation techniques allowing accelerated and improved rehabilitation for scoliosis operated patients in the establishment. To improve patient care, the Investigators want to develop the ERAS program. The objective of this research will be to validate the feasibility of getting up early on D0 in post-anesthesia care unit (PACU) or ICU in children who have just had surgery for idiopathic scoliosis.
Read the detailed description
The study hypothesize that entry into an early mobilizing physiotherapy program, i.e., from the immediate postoperative period, from the PACU or the ICU, could improve the outcome of patients in terms of pain, anxiety, re-empowerment, length of stay and ultimately overall satisfaction.
Following a general anesthesia, the patient is monitored in the PACU the time to recover respiratory, neurological and hemodynamic autonomy. It is also in PACU that the team optimize pain management, through opioid treatments if necessary.
The first physiotherapy sessions including sitting on the edge of the bed and getting up for the first time are technical acts that require good cooperation from the patient and adequate pain relief. Usually, physiotherapy rehabilitation is started on the first postoperative day. However, once the stability of vital functions and the analgesia have been optimized, the early postoperative phase seems to be a privileged moment to begin this rehabilitation program. This early physiotherapy treatment could also have a beneficial psychological effect on the rest of the treatment.
Although most centers tend to generalize ERAS programs and early rehabilitation techniques, to date there is no publication on the feasibility of early rehabilitation from the immediate postoperative period, nor on the expected benefit of such a program. The fact of starting the rehabilitation immediately postoperatively or as soon as the PACU could have several advantages. The optimization of pain management performed in the PACU could facilitate the physiotherapy session. In addition, it turns out that the rehabilitation and progressive re-empowerment of the patient have a positive psychological and physical effect on the rest of the treatment. The early re-empowerment of the patient allows him to regain control of his body and his care which has a positive psychological effect on the care. Early mobilization fights muscle contracture with positive effects on pain and patient comfort.
This research propose to validate the feasibility of standing up early on D0 in PACU or ICU in children who have just had surgery for idiopathic scoliosis. Immediately postoperatively, during his stay in a PACU or ICU, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position.
- Conditions
- Idiopathic Scoliosis, ERAS
- Being tested
- anticipated bipedal standing position in the immediate post-operative phase
- Keywords
- idiopathic scoliosis, physiotherapies, ERAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anticipated bipedal standing position in the immediate post-operative phaseProcedure or surgery
Realization of a first stand-up within 6 hours after entry into PACU or extubation for admitted patients intubated, in PACU or on admission to ICU by a state-certified physiotherapist.
Immediately postoperatively, during his stay in a Intensive Care Unit, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position.
| Study group | Role | What they receive |
|---|---|---|
| Group experimental | Experimental | Patient between 12 and 18 years old with a spinal surgery for idiopathic scoliosis programmed. Immediately postoperatively, during his stay in a PACU or ICU, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position. Receives: Procedure: anticipated bipedal standing position in the immediate post-operative phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of the anticipated bipedal standing position within 6 hours postoperative
success of a Stand up in a bipedal standing position during more than 3 seconds in the post-operative phase within 6 hours postoperative. The procedure of anticipated bipedal standing position is realised according to the same procedure as usual but carried out in advance, at six hours postoperative, after validation of the prerequisites for the procedure.
Measured: Hour 6
Secondary outcomes (11)
pain measured by visual analog scale at baseline
pain measured by visual analog scale at baseline. The visual analog scale measure the pain from 0 to 10. 0 means no pain and 10 means the worst possible pain
Measured: day 0
pain measured by visual analog scale at the first day postoperative
pain measured by visual analog scale at the first day postoperative. The visual analog scale measure the pain from 0 to 10. 0 means no pain and 10 means the worst possible pain
Measured: day 1
pain measured by visual analog scale at the second day postoperative
pain measured by visual analog scale at the second day postoperative. The visual analog scale measure the pain from 0 to 10. 0 means no pain and 10 means the worst possible pain
Measured: day 2
pain measured by visual analog scale at the third day postoperative
pain measured by visual analog scale at the third day postoperative. The visual analog scale measure the pain from 0 to 10. 0 means no pain and 10 means the worst possible pain
Measured: day 3
Morphine consumption baseline
consumption in morphine per day
Measured: Day 0
Morphine consumption at Day 1
consumption in morphine per day
Measured: Day 1
Morphine consumption at Day 2
consumption in morphine per day
Measured: Day 2
Morphine consumption at Day 3
consumption in morphine per day
Measured: Day 3
Postoperative length of stay
Postoperative length of stay
Measured: Day 7
success of the anticipated bipedal standing position in the early post operative phase (within 2 hours postoperative)
success of a Stand up in a bipedal standing position during more than 3 seconds in the immediate post-operative phase (i.e., within 2 hours postoperative). The procedure of anticipated bipedal standing position is realised according to the same procedure as usual but carried out in advance, in the early post operative phase in the post-anesthesia care unit (PACU), after validation of the prerequisites for the procedure.
Measured: Hour 2
success of the anticipated bipedal standing position in the early post operative phase (within 3 hours postoperative)
success of a Stand up in a bipedal standing position during more than 3 seconds in the post-operative phase (i.e., within 3 hours postoperative). The procedure of anticipated bipedal standing position is realised according to the same procedure as usual but carried out in advance, in the early post operative phase in the post-anesthesia care unit (PACU), after validation of the prerequisites for the procedure.
Measured: Hour 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start19 Mar 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Dr DELORT, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152601
- Sponsor's protocol ID
- RC31/21/0611
- Acronym
- LevPOS
- Status last verified
- Oct 2026
- First submitted
- 13 Sep 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Standing in Children and Adolescent Operated on for Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06152601
- Acronym / sponsor ID
- LevPOS / RC31/21/0611
- Conditions
- Idiopathic Scoliosis, ERAS
- Keywords
- idiopathic scoliosis, physiotherapies, ERAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 30 Nov 2023 (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.
The implementation of an enhanced rehabilitation after surgery (ERAS) program in major orthopedic surgery and in scoliosis surgery in children and adolescents has become a marker of good practice. Investigators are already applying anesthetic, surgical, peri-operative medicine and rehabilitation techniques allowing accelerated and improved rehabilitation for scoliosis operated patients in the establishment. To improve patient care, the Investigators want to develop the ERAS program. The objective of this research will be to validate the feasibility of getting up early on D0 in post-anesthesia care unit (PACU) or ICU in children who have just had surgery for idiopathic scoliosis.
Detailed description
The study hypothesize that entry into an early mobilizing physiotherapy program, i.e., from the immediate postoperative period, from the PACU or the ICU, could improve the outcome of patients in terms of pain, anxiety, re-empowerment, length of stay and ultimately overall satisfaction.
Following a general anesthesia, the patient is monitored in the PACU the time to recover respiratory, neurological and hemodynamic autonomy. It is also in PACU that the team optimize pain management, through opioid treatments if necessary.
The first physiotherapy sessions including sitting on the edge of the bed and getting up for the first time are technical acts that require good cooperation from the patient and adequate pain relief. Usually, physiotherapy rehabilitation is started on the first postoperative day. However, once the stability of vital functions and the analgesia have been optimized, the early postoperative phase seems to be a privileged moment to begin this rehabilitation program. This early physiotherapy treatment could also have a beneficial psychological effect on the rest of the treatment.
Although most centers tend to generalize ERAS programs and early rehabilitation techniques, to date there is no publication on the feasibility of early rehabilitation from the immediate postoperative period, nor on the expected benefit of such a program. The fact of starting the rehabilitation immediately postoperatively or as soon as the PACU could have several advantages. The optimization of pain management performed in the PACU could facilitate the physiotherapy session. In addition, it turns out that the rehabilitation and progressive re-empowerment of the patient have a positive psychological and physical effect on the rest of the treatment. The early re-empowerment of the patient allows him to regain control of his body and his care which has a positive psychological effect on the care. Early mobilization fights muscle contracture with positive effects on pain and patient comfort.
This research propose to validate the feasibility of standing up early on D0 in PACU or ICU in children who have just had surgery for idiopathic scoliosis. Immediately postoperatively, during his stay in a PACU or ICU, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group experimental | Experimental | Procedure: anticipated bipedal standing position in the immediate post-operative phasePatient between 12 and 18 years old with a spinal surgery for idiopathic scoliosis programmed. Immediately postoperatively, during his stay in a PACU or ICU, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Programming of spinal surgery via the posterior approach for idiopathic scoliosis eligible for an ERAS program
- Person affiliated or beneficiary of a social security scheme
- Free, informed and written consent signed by the legal guardians of the minor patient
- Free and informed consent of the minor patient
Key exclusion criteria (12 listed)
- Scoliosis linked to a neuromuscular pathology
- Physical status score of American Society of Anesthesiologists (ASA) > 2
- Severe or unbalanced associated conditions (cardiac, pulmonary, coagulopathy or anticoagulant treatment with curative intent, long-term corticosteroid therapy)
- Malnutrition
- Major cognitive disorders
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 |
|---|---|---|
| anticipated bipedal standing position in the immediate post-operative phaseRealization of a first stand-up within 6 hours after entry into PACU or extubation for admitted patients intubated, in PACU or on admission to ICU by a state-certified physiotherapist. Immediately postoperatively, during his stay in a Intensive Care Unit, the patient will be offered a physiotherapy session including a lifting phase in a bipedal standing position. | Procedure or surgery | Group experimental |
Primary outcome
success of the anticipated bipedal standing position within 6 hours postoperative
Time frame: Hour 6
success of a Stand up in a bipedal standing position during more than 3 seconds in the post-operative phase within 6 hours postoperative. The procedure of anticipated bipedal standing position is realised according to the same procedure as usual but carried out in advance, at six hours postoperative, after validation of the prerequisites for the procedure.
11 secondary outcomes
pain measured by visual analog scale at baseline
Time frame: day 0
pain measured by visual analog scale at the first day postoperative
Time frame: day 1
pain measured by visual analog scale at the second day postoperative
Time frame: day 2
pain measured by visual analog scale at the third day postoperative
Time frame: day 3
Morphine consumption baseline
Time frame: Day 0
Morphine consumption at Day 1
Time frame: Day 1
Morphine consumption at Day 2
Time frame: Day 2
Morphine consumption at Day 3
Time frame: Day 3
Postoperative length of stay
Time frame: Day 7
success of the anticipated bipedal standing position in the early post operative phase (within 2 hours postoperative)
Time frame: Hour 2
success of the anticipated bipedal standing position in the early post operative phase (within 3 hours postoperative)
Time frame: Hour 3
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 29 Oct 2026.
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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.
François Dr DELORT principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anticipated bipedal standing position in the immediate post-operative phase in people with Idiopathic Scoliosis and ERAS, run by University Hospital, Toulouse 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 4 inclusion and 12 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 29 Oct 2026. 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?
success of the anticipated bipedal standing position within 6 hours postoperative (time frame: Hour 6). 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 29 Oct 2026.