Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism (SORONOUS)

April 7, 2026 updated by: University Hospital, Montpellier

Cerebral palsy is the primary cause of disability in France. It is a non-progressive condition leading to movement and posture troubles, but also to cognitive and sensory problems. Spasticity is one of the most regular consequences. It leads to a muscular failure with permanent contractions. Muscular dysfunction can generate scoliosis (in 60% of cases). Scoliosis can lead to pain, sitting difficulties (with chances of bedsores), and cardiopulmonary complications.

These children often have cachexia (eating difficulties, trouble with deglutition). It leads to a weakening of their immune defenses, which favors post-operative infections, a weakening of their respiratory muscles, and circulatory difficulties with negative effects on scarring. Cachexia is a pessimistic prognosis.

A back brace can be used to contain the scoliosis but never cures it. Another option for treating this affection would be surgery. Surgery is another treatment. It consists in straightening and holding the spine with metal rods, held by vertebral anchors placed at both ends of the scoliosis. Surgery is the gold standard.

Surgery induces risks such as bleeding, healing complications and infection. The probability to face complications increases with malnutrition.

The first hypothesis is that surgery could improve the nutrients intakes and the weight of the patient.

The investigators also believe that it could improve the patient's body composition (body fat and lean mass) and their basic metabolic rate.

The third hypothesis is that surgery-involved changes (nutrition enhancement, sitting improvement, decrease of respiratory work) could lead to an improvement of the patient's quality and life and respiratory functions.

The SORONOUS project aim to prove the benefits of this surgery from a nutritional and from a general point of view in order to help make the surgical decision and avoid any care delay. In addition, it aim to identify and quantify the post-operative weight gain; while providing us with a better understanding of the behavior of pre-operative cachexia among these patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

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Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects with cerebral palsy
  • Subjects between 10 and 20 years old
  • Neuromuscular scoliosis requiring surgical care (accepted by the patient or their legal representatives)
  • Subjects escaping scoliosis treatment with a brace

Exclusion Criteria:

  • History of spine surgery
  • Impossible follow-up during the study time
  • Peripheral or non spastic palsy
  • Palsy caused by a medullary injury
  • Subject with a contraindication to DXA scan examination (e.g. coronary stents or cardiac metal sutures, pacemaker or automatic defibrillator)
  • Absence of voluntary and informed consent signed by the patient or their legal representatives
  • Patient or their legal representatives with no social security affiliation
  • Patient or their legal representatives deprived of freedom by a judicial or administrative decision
  • Pregnant, laboring, or breastfeeding woman

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Assessment of group before and after spinal surgery
Assessment of food intake, body composition, energy expenditure, quality of life, achievement of customized goals before and after spinal surgery
Diagnostic test: Absorptiometry and indirect calorimetry

Assessment of body composition with dual-energy absorptiometry : 1 month before surgery and 6 months after surgery

Assessment of energy expenditure with indirect calorimetry : 1 month before surgery and 6 months after surgery

Behavioral: Questionnaires

Assessment of food intake with a standardized questionnaire : 6 months before surgery, 1 month before surgery, 3 months after surgery and 6 months after surgery

Assessment of quality of life with the CP Child Score questionnaire : 6 months before surgery, 1 month before surgery, 3 months after surgery and 6 months after surgery

Assessment of the achievement of customized goals established one month before the scoliosis surgery : 3 months after surgery and 6 months after surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dietary intakes modifications before and after scoliosis surgery
Time Frame: Between 1 month before surgery and 6 months after surgery
Assessment of the dietary intakes in kcal/day (dietary intakes per os and/or gastrostomy and/or nasogastric tube) by nutrition questionnaires and based on the average food intake over the last 7 days. Caregivers will provide information on food intake for each day and each meal during the seven days preceding the consultation using a food intake sheet. A standardized table will be used to calculate the equivalents between food intake and energy intake (kcal). An average will be calculated over the 7 days to obtain a dietary intake in kcal/day. Comparison of the dietary intakes between one month before scoliosis surgery and six months after surgery
Between 1 month before surgery and 6 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dietary intakes modifications before and after scoliosis surgery
Time Frame: Between 1 month before surgery and 3 months after surgery
Assessment of the dietary intakes in kcal/day (dietary intakes per os and/or gastrostomy and/or nasogastric tube) by nutrition questionnaires and based on the average food intake over the last 7 days. Caregivers will provide information on food intake for each day and each meal during the seven days preceding the consultation using a food intake sheet. A standardized table will be used to calculate the equivalents between food intake and energy intake (kcal). An average will be calculated over the 7 days to obtain a dietary intake in kcal/day. Comparison of the dietary intakes between one month before scoliosis surgery and six months after surgery
Between 1 month before surgery and 3 months after surgery
Weight comparison before and after scoliosis surgery
Time Frame: Between 1 month before surgery and 6 months after surgery
Weight measurement in kilograms of each participant. Weight comparison between one month before surgery and six months after surgery
Between 1 month before surgery and 6 months after surgery
Weight comparison before and after scoliosis surgery
Time Frame: Between 1 month before surgery and 3 months after surgery
Weight measurement in kilograms of each participant. Weight comparison between one month before surgery and three months after surgery
Between 1 month before surgery and 3 months after surgery
Assessment of the quality of life before and after scoliosis surgery
Time Frame: Between 1 month before surgery and 6 months after surgery

Assessment of the quality of life, comfort, transfers and mobility with the CP Child Score questionnaire (Caregivers' Priorities and Child Health Index of Life with Disabilities). Each domain and the total score are standardized on a scale from 0 to 100. Higher scores indicate better comfort, function, and well-being of the child as perceived by the caregiver.

Comparison of the 1 month before surgery and 6 months after surgery scores
Between 1 month before surgery and 6 months after surgery
Assessment of the quality of life before and after scoliosis surgery
Time Frame: Between 1 month before surgery and 3 months after surgery

Assessment of the quality of life, comfort, transfers ad mobility with the CP Child Score questionnaire (Caregivers' Priorities and Child Health Index of Life with Disabilities). Each domain and the total score are standardized on a scale from 0 to 100. Higher scores indicate better comfort, function, and well-being of the child as perceived by the caregiver.

Comparison of the 1 month before surgery and 3 months after surgery scores
Between 1 month before surgery and 3 months after surgery
Change of respiratory rate before and after surgery
Time Frame: Between 1 month before surgery and 6 months after surgery

Assessment of the respiratory rate (breaths per minute) through clinical examination.

Comparison of the respiratory rate between one month before surgery and six months after surgery
Between 1 month before surgery and 6 months after surgery
Change of respiratory rate before and after surgery
Time Frame: Between one month before surgery and three months after surgery

Assessment of the respiratory rate (breaths per minute) through clinical examination.

Comparison of the respiratory rate between one month before surgery and six months after surgery
Between one month before surgery and three months after surgery
Change of metabolic rate before and after surgery
Time Frame: Between 1 month before surgery and 6 months after surgery
Quantification of the basic metabolic rate (kcal/d) with indirect calorimetry (inhalation chamber or gas mask). Comparison of the metabolic rate one month before surgery and six months after surgery
Between 1 month before surgery and 6 months after surgery
Change of weight distribution before and after surgery
Time Frame: Between one month before surgery and six months after surgery

Assessment of the body composition with dual-energy absorptiometry (DEXA scan). The body composition, including body fat (kg, %) and lean mass (kg, %) will be assessed on the whole body and on different body segments (upper limbs, lower limbs and trunk).

Comparison of the body composition one month before surgery and six months after surgery
Between one month before surgery and six months after surgery
Assessment of the achievement of customized goals established one month before the scoliosis surgery
Time Frame: 3 months after surgery
Specific customized goals will be established one month before surgery with the Goal Attainment Scale. The goals will concern several aspects of daily life (e.g. to dress up, to brush your teeth). The initial Goal is set at -2 point scale. on Each goal is rated on a 5-point scale: Much less than expected (-2); Somewhat less than expected (-1) ; Expected level of achievement (0); Much more than expected outcome (+2), Somewhat more than expected (+1). A higher score (closer to +2) indicates a better outcome, meaning the goal was achieved beyond expectations. Assessment of the achievement of these goals three months after surgery
3 months after surgery
Assessment of the achievement of customized goals established one month before the scoliosis surgery
Time Frame: 6 months after surgery
Specific customized goals will be established one month before surgery with the Goal Attainment Scale. The goals will concern several aspects of daily life (e.g. to dress up, to brush your teeth). The initial Goal is set at -2 point scale. on Each goal is rated on a 5-point scale: Much less than expected (-2); Somewhat less than expected (-1) ; Expected level of achievement (0); Much more than expected outcome (+2), Somewhat more than expected (+1). A higher score (closer to +2) indicates a better outcome, meaning the goal was achieved beyond expectations. Assessment of the achievement of these goals six months after surgery
6 months after surgery
Change of hypoxemia before and after surgery
Time Frame: Between 1 month before surgery and 3 months after surgery

Assessment through night-time oximetry of the number of hypoxemia episodes with oxygen saturation (SpO2 < 90%) and measurement of percentage of time spent in hypoxemia.

Comparison of the hypoxemia between one month before surgery and six months after surgery.
Between 1 month before surgery and 3 months after surgery
Change of hypoxemia before and after surgery
Time Frame: Between 1 month before surgery and 6 months after surgery

Assessment through night-time oximetry of the number of hypoxemia episodes with oxygen saturation (SpO2 < 90%) and measurement of percentage of time spent in hypoxemia.

Comparison of the hypoxemia between one month before surgery and six months after surgery.
Between 1 month before surgery and 6 months after surgery
Change of hypercapnia before and after surgery
Time Frame: Between 1 month before surgery and 3 months after surgery

Assessment through night capnography of the number of hypercapnia episodes (PaCO2 > 50 mmHg) and measurement of percentage of time spent in hypercapnia.

Comparison of the hypercapnia between one month before surgery and six months after surgery.
Between 1 month before surgery and 3 months after surgery
Change of hypercapnia before and after surgery
Time Frame: Between 1 month before surgery and 6 months after surgery

Assessment through night capnography of the number of hypercapnia episodes (PaCO2 > 50 mmHg) and measurement of percentage of time spent in hypercapnia.

Comparison of the hypercapnia between one month before surgery and six months after surgery.
Between 1 month before surgery and 6 months after surgery
Change of tidal volume before and after surgery
Time Frame: Between 1 month before surgery and 3 months after surgery
Assessment of the tidal volume (mL) through spirometry Comparison of the tidal volume between one month before surgery and three months after surgery
Between 1 month before surgery and 3 months after surgery
Change of tidal volume before and after surgery
Time Frame: Between 1 month before surgery and 6 months after surgery
Assessment of the tidal volume (mL) through spirometry Comparison of the tidal volume between one month before surgery and three months after surgery
Between 1 month before surgery and 6 months after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL25_0018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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