MinorPHYPSYSCOLNCT07852286
Evaluation of a Prehabilitation Program in Patients Requiring Scoliosis Surgery.
A study testing Pre-habilitation program in people with Minor and Scoliosis; Juvenile, run by University Hospital, Grenoble at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Minor, Scoliosis; Juvenile, Scoliosis; Adolescence
- What is being tested?
- Pre-habilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 30 Oct 2029
- Phase
- Interventional
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient with severe idiopathic scoliosis requiring surgery
- No known associated pathology
- No previous surgical treatment on the spine
- Able to understand recommendations and express oneself in French
- Child whose parents speak French fluently and are able to understand instructions
- Parent with a myCHUGA account
Show all 10Show fewer
- Having a cellphone and an internet connection
- Child whose parents are affiliated with social security or beneficiaries of such a scheme
- Children who gave their consent to participate in the study
- Child whose parents have signed the study consent form
Who cannot join
- Refusal of consent by a child of an age to give consent or by parents
- Subject excluded from another study
- Subject who cannot be contacted in case of an emergency
- Protected persons covered by articles L1121-5, L1121-6 and L1121-8 of the French Public Health Code.
- Patients whose parents are covered by Article L1121-8 of the French Public Health Code (persons subject to legal protection measures or unable to express their consent)
- Personnel with a hierarchical relationship with the principal investigator
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, Grenoble
La Tronche
Aurélien COURVOISIER, +33 04 76 76 37 10, acourvoisier@chu-grenoble.fr
Olivier DANIEL, +33 04 76 76 37 10, odaniel@chu-grenoble.fr
About this study
Official title: Evaluation of a Prehabilitation Program in Patients Requiring Scoliosis Surgery. A Single-center, Randomized, Controlled, Parallel-group, Open-label Study.
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.
- Conditions
- Minor, Scoliosis; Juvenile, Scoliosis; Adolescence, Surgery, Prehabilitation
- Being tested
- Pre-habilitation program
- Keywords
- Prehabilitation program, Scoliosis surgery, Adapted Physical Activity, Quality of life, Anxiety, Pain, Sleep quality
- Medical subject headings
- Scoliosis, Anxiety Disorders, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-habilitation programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard care for scoliosis surgery - Patients not participating in the prehabilitation program |
| Prehabilitation program group | Experimental | Patients participating in the 3-month prehabilitation program Receives: Other: Pre-habilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day before surgery
Secondary outcomes (16)
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)
Measured: 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)
Measured: 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)
Measured: 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"
Measured: 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
Measured: One day before surgery
Impact on changes over time in quality of life score (EQ5D-Y-3L) in each group
EQ5D-Y-3L questionnaire
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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]
Measured: One day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MinorStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852286
- Sponsor's protocol ID
- 38RC23.0316
- Other IDs
- 2025-A01259-40
- Acronym
- PHYPSYSCOL
- Status last verified
- Sep 2026
- First submitted
- 18 May 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided