An interventional study of Pre-habilitation program in Minor, Scoliosis; Juvenile and Scoliosis; Adolescence, sponsored by University Hospital, Grenoble. Not yet recruiting at 1 site in France. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Other
Scoliosis is a curvature of the spine that, in the most severe cases, may require surgical treatment. This surgery is invasive and complex, causing anxiety for children, adolescents, and their parents. In-hospital medical and surgical care is well standardized, but there are significant disparities among patients (and their families) in the psychological and physical management of this experience.
The hypothesis of the study is that a specific physical and psychological prehabilitation program (a personalized preparation known as "pre-surgical prehabilitation") could improve patient care, particularly in managing anxiety and pre- and postoperative pain throughout the care pathway.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's planned enrollment of 60 is above the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard care for scoliosis surgery - Patients not participating in the prehabilitation program
Patients participating in the 3-month prehabilitation program
Other: Pre-habilitation program
Prehabilitation program in 2 steps Step 1- Physical assessment to evaluate patient's level of physical activity, motor skills, and sleep patterns: * Cardiorespiratory fitness (maximal exercise test) to measure VO2max and respiratory function. * Physical activity : Actigraphy (3 days) ; Physical Activity \[Questionnaire for Older Children (PAQ-C) or Adolescents (PAQ-A)\] * Motor skills: Flexibility ("sit and reach" test) ; Isometric strength (handgrip) ; Static balance ("Flamingo" test) ; Dynamic balance * Sleep quality: Pittsburgh Sleep Quality Index ; Actigraphy for 3 days ; Sleep diary Step 2- Personalized pre-rehabilitation program during 3 months, realized at home. Physical activity will be monitored by an adapted physical education teacher. Patient will complete a physical activity logbook during the pre-rehabilitation program, in which he will record the exercises performed and any difficulties encountered, so that subsequent sessions can be adapted accordingly.
Impact of a personalized prehabilitation program
Hierarchical analysis of 3 subcriteria: pediatric quality of life, anxiety, and pain (difference in the total score on each scale between the two groups): * Pediatric quality of life was assessed using the PedsQL 4.0 Generic Core Scale, which consists of 23 items; the total score on this scale ranges from 0 to 100, with a higher score indicating a better quality of life. * The HAD scale is a tool used to screen for anxiety (7 questions) and depression (7 questions), with a maximum score of 21 for each category (7 or fewer: no symptoms; 8 to 10: possible symptoms; 11 or more: confirmed symptoms) * Pain will be assessed using a visual analog scale (VAS) ranging from 0 "no pain" to 10 "maximum pain." The ranking of the three subcriteria will be determined in advance by a vote of all patients (point-based voting, by majority vote). Parents will be asked to follow the same procedure (vote) to conduct a sensitivity analysis on the results obtained.
Time frame: One day before surgery
Impact on changes over time in the total score and the various dimensions of the Pediatric Quality of Life Inventory (PedsQL 4.0) for children in each patient group
Total score and scores on each dimension of the scale (child self-report) (Physical Functioning ; Emotional Functioning : Social Functioning ; School Functioning)
Time frame: Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery
Impact on changes over time in the total score and the various dimensions of the Pediatric Quality of Life Inventory (PedsQL 4.0) for parents in each group
Total score and scores on each dimension of the scale (child self-report) (Physical Functioning ; Emotional Functioning : Social Functioning ; School Functioning)
Time frame: Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery
Impact on changes over time in the anxiety score (HAD scale) in each patient group
HAD scale is a tool used to screen for anxiety (7 questions) and depression (7 questions) with maximum score for each category = 21 (7 or less: no symptoms ; 8 to 10: possible symptoms ; 11 or more: definite symptom)
Time frame: Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery
Impact on changes over time in the pain score (VAS) in each patient group
Pain will be assessed using Visual Analog Scale (VAS) ranging from 0 "no pain" to 10 "maximum pain"
Time frame: Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery
Impact of a personalized prehabilitation program on preoperative quality of life (EQ5D-Y-3L) in pediatric patients undergoing scoliosis surgery.
EQ5D-Y-3L questionnaire
Time frame: One day before surgery
Impact on changes over time in quality of life score (EQ5D-Y-3L) in each group
EQ5D-Y-3L questionnaire
Time frame: Preoperative consultation (inclusion) ; one day before surgery ; 3, 9 and 15 months after surgery
Description of physical activities per session/weekly (to be determined) by patients (Pre-habilitation Group).
Descriptive analysis of the exercises performed, the intensity levels (Level 1 - Level 2 - Level 3), and the difficulty as perceived by the patients while performing the exercises (the child's assessment of whether "it is difficult to do or not" on a scale of 0 to 10).
Time frame: During the 12 weeks of the pre-habilitation program
Patients' level of fitness for duty (Pre-habilitation Group).
Fitness for duty will be assessed by measuring VO2max (L/min)
Time frame: Initial assessment (within 10 days of inclusion)
Patients' level of physical activity (Pre-habilitation Group).
Physical activity will be eassessed using actigraphy (worn at home for 3 days) and PAQ-C (Physical Activity Questionnaire-Children) or PAQ-A (Physical Activity Questionnaire-Adolescents).
Time frame: Initial assessment (within 10 days of inclusion)
Patients' level of motor skills (flexibility) at the initial assessment (Pre-habilitation Group)
Flexibility will be assessed using "Sit and reach test", measured in centimetres, positive or negative value
Time frame: Initial assessment (within 10 days of inclusion)
Patients' level of motor skills (Isometric strength) at the initial assessment (Pre-habilitation Group)
Isometric strength will be assessed using a handgrip, measured in Arbitrary Units
Time frame: Initial assessment (within 10 days of inclusion)
Patients' level of motor skills (Static balance) at the initial assessment (Pre-habilitation Group)
Static balance will be assessed using using Flamingo test, measured in second
Time frame: Initial assessment (within 10 days of inclusion)
Patients' level of motor skills (Dynamic balance) at the initial assessment (Pre-habilitation Group)
Dynamic balance will be measured by the number of steps taken
Time frame: Initial assessment (within 10 days of inclusion)
Sleep patterns at the initial assessment (Pre-habilitation Group).
Pittsburgh Sleep Quality Index (PSQI) Actigraphy (over 3 nights at home) with a sleep diary
Time frame: Initial assessment (within 10 days of inclusion)
Usability, use by children, and satisfaction with the digital solution (CHUGA patient portal) (Pre-habilitation Group).
Individual interview conducted with an ergonomist to assess patient and parent satisfaction with the digital solution (CHUGA patient portal), with a view to improving it and its use by children.
Time frame: 3 months after surgery (follow-up visit)
Definition of minimal clinically important differences (MCID) for the three sub-criteria of quality of life, anxiety, and pain, for the patient and their parents (Pre-habilitation group).
Patient and parent responses to the questions: * "Are you feeling less pain?" / "Is your child feeling less pain?" \[yes/no\] * "Are you less stressed?" / "Is your child less stressed?" \[yes/no\] * "Do you feel better?" / "Does your child feel better?" \[yes/no\]
Time frame: One day before surgery
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University Hospital, Grenoble