Cerebral PalsySORONOUSNCT07255495
Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism
A study testing Absorptiometry and indirect calorimetry and Questionnaires in people with Cerebral Palsy and Scoliosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Cerebral Palsy, Scoliosis
- What is being tested?
- Absorptiometry and indirect calorimetry and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University hospital Montpellier
Montpellier, 34295
DELPONT Marion, MD, m-delpont@chu-montpellier.fr
BRUT Océane, oceane.brut@chu-montpellier.fr
About this study
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.
Read more
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.
- Conditions
- Cerebral Palsy, Scoliosis
- Being tested
- Absorptiometry and indirect calorimetry, Questionnaires
- Keywords
- energy metabolism, quality of life, nutritional support
- Medical subject headings
- Cerebral Palsy, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorptiometry and indirect calorimetryDiagnostic test
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
QuestionnairesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Assessment of group before and after spinal surgery | Experimental | Assessment of food intake, body composition, energy expenditure, quality of life, achievement of customized goals before and after spinal surgery Receives: Diagnostic Test: Absorptiometry and indirect calorimetry; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary intakes modifications before and after scoliosis 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
Measured: Between 1 month before surgery and 6 months after surgery
Secondary outcomes (17)
Dietary intakes modifications before and after scoliosis 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
Measured: Between 1 month before surgery and 3 months after surgery
Weight comparison before and after scoliosis surgery
Weight measurement in kilograms of each participant. Weight comparison between one month before surgery and six months after surgery
Measured: Between 1 month before surgery and 6 months after surgery
Weight comparison before and after scoliosis surgery
Weight measurement in kilograms of each participant. Weight comparison between one month before surgery and three months after surgery
Measured: Between 1 month before surgery and 3 months after surgery
Assessment of the quality of life before and after scoliosis 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
Measured: Between 1 month before surgery and 6 months after surgery
Assessment of the quality of life before and after scoliosis 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
Measured: Between 1 month before surgery and 3 months after surgery
Change of respiratory rate before and 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
Measured: Between 1 month before surgery and 6 months after surgery
Change of respiratory rate before and 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
Measured: Between one month before surgery and three months after surgery
Change of metabolic rate before and 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
Measured: Between 1 month before surgery and 6 months after surgery
Change of weight distribution before and 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
Measured: Between one month before surgery and six months after surgery
Assessment of the achievement of customized goals established one month before the scoliosis 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
Measured: 3 months after surgery
Assessment of the achievement of customized goals established one month before the scoliosis 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
Measured: 6 months after surgery
Change of hypoxemia before and 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.
Measured: Between 1 month before surgery and 3 months after surgery
Change of hypoxemia before and 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.
Measured: Between 1 month before surgery and 6 months after surgery
Change of hypercapnia before and 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.
Measured: Between 1 month before surgery and 3 months after surgery
Change of hypercapnia before and 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.
Measured: Between 1 month before surgery and 6 months after surgery
Change of tidal volume before and 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
Measured: Between 1 month before surgery and 3 months after surgery
Change of tidal volume before and 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
Measured: Between 1 month before surgery and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255495
- Sponsor's protocol ID
- RECHMPL25_0018
- Acronym
- SORONOUS
- Status last verified
- Apr 2026
- First submitted
- 25 Aug 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism
- ClinicalTrials.gov ID
- NCT07255495
- Acronym / sponsor ID
- SORONOUS / RECHMPL25_0018
- Conditions
- Cerebral Palsy, Scoliosis
- Keywords
- energy metabolism, quality of life, nutritional support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 1 Dec 2025 (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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of group before and after spinal surgery | Experimental | Diagnostic Test: Absorptiometry and indirect calorimetry, Behavioral: QuestionnairesAssessment of food intake, body composition, energy expenditure, quality of life, achievement of customized goals before and after spinal surgery |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| Absorptiometry and indirect calorimetryAssessment 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 | Diagnostic test | Assessment of group before and after spinal surgery |
| QuestionnairesAssessment 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 | Behavioural | Assessment of group before and after spinal surgery |
Primary outcome
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
17 secondary outcomes
Dietary intakes modifications before and after scoliosis surgery
Time frame: 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 comparison before and after scoliosis surgery
Time frame: 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 before and after scoliosis surgery
Time frame: 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
Change of respiratory rate before and after surgery
Time frame: 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
Change of weight distribution before and after surgery
Time frame: 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
Assessment of the achievement of customized goals established one month before the scoliosis surgery
Time frame: 6 months after surgery
Change of hypoxemia before and after surgery
Time frame: 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
Change of hypercapnia before and after surgery
Time frame: 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
Change of tidal volume before and after surgery
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorptiometry and indirect calorimetry and Questionnaires in people with Cerebral Palsy and Scoliosis, run by University Hospital, Montpellier 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 9 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: opening soon, as of the sponsor's last update on 13 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DELPONT Marion, MD (0467335035 ext. 33, m-delpont@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary intakes modifications before and after scoliosis surgery (time frame: Between 1 month before surgery and 6 months after surgery). 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 13 Apr 2026.