Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism

NCT07255495 | Not Yet Recruiting

• 1 other identifier: RECHMPL25_0018
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Palsy; Scoliosis

Keywords

energy metabolism; quality of life; nutritional support

Outcome Measures

Primary Outcomes (1)

• 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

  Between 1 month before surgery and 6 months after surgery

Secondary Outcomes (17)

• Dietary intakes modifications before and after scoliosis surgery

  Between 1 month before surgery and 3 months after surgery

• Weight comparison before and after scoliosis surgery

  Between 1 month before surgery and 6 months after surgery

• Weight comparison before and after scoliosis surgery

  Between 1 month before surgery and 3 months after surgery

• Assessment of the quality of life before and after scoliosis surgery

  Between 1 month before surgery and 6 months after surgery

• Assessment of the quality of life before and after scoliosis surgery

  Between 1 month before surgery and 3 months after surgery

Study Arms (1)

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

Diagnostic Test: Absorptiometry and indirect calorimetry; Behavioral: Questionnaires

Interventions

Questionnaires BEHAVIORAL

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

Assessment of group before and after spinal surgery

Absorptiometry and indirect calorimetry DIAGNOSTIC_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

Assessment of group before and after spinal surgery

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Cerebral Palsy; Scoliosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

DELPONT Marion, MD

CONTACT

0467335035; m-delpont@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: December 1, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)