An observational study in Cerebral Palsy and Hemiplegia, sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française. Recruiting at 1 site in France. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Observational
This retrospective study evaluates the functional impact of individualized multisite neuro-orthopedic upper limb surgery in children with unilateral cerebral palsy (hemiplegic CP). Using a before-and-after design in which each patient serves as their own control, the study analyzes data collected in routine clinical care up to 3-5 years before and 1-2 years after surgery. The primary outcome is upper limb function as measured by the Modified Melbourne Assessment (MA2), which assesses range of motion and dexterity. Secondary outcomes include unimanual precision and fluidity (MA2), global manual dexterity (Box and Block Test), bimanual performance (Assisting Hand Assessment), and patient/parent satisfaction. Approximately 70 patients operated at the Centre Médico-Chirurgical de Réadaptation des Massues between January 2012 and June 2025 will be included. The study also aims to identify factors influencing surgical outcomes, such as age at surgery, associated cognitive or sensory impairments, and adherence to post-operative orthotic protocols.
Background and Rationale Cerebral palsy (CP) is the most common cause of neurological disability in children, with a prevalence of approximately 2-2.5 per 1,000 live births in Europe. It results from irreversible lesions of the developing brain, causing lifelong motor and postural disorders often accompanied by cognitive or sensory difficulties. Hemiplegia accounts for approximately 30% of CP cases and predominantly affects the upper limb. Spasticity and dyskinesia impair unimanual capacities (range of motion, dexterity, fluidity) as well as bimanual performance.
Focal treatment with botulinum toxin injections combined with occupational therapy has demonstrated efficacy for targeted functional goals. However, the functional effects of upper limb surgery in the context of CP remain poorly documented, with existing systematic reviews highlighting the weakness of current evidence.
Neuro-orthopedic upper limb surgery in children with CP is individualized and multisite, combining several procedures tailored to each patient's functional profile and goals. These may include: short adductor of thumb release, flexor carpi ulnaris release or transfer to extensor carpi radialis brevis, finger flexor lengthening, round pronator release, elbow flexor lengthening, wrist arthrodesis, and others. At the Centre des Massues, all patients undergo a pre-surgical evaluation and a multidisciplinary surgical planning meeting (Équipe Médico-Chirurgicale) promoting shared decision-making, followed by specialized neuro-orthopedic surgery and structured post-operative rehabilitation.
A preliminary retrospective analysis of 23 patients at the Centre des Massues demonstrated that this integrated care pathway improved unimanual upper limb function and patient satisfaction. However, the cohort required expansion to better characterize bimanual performance outcomes and to identify functional subgroups with more homogeneous surgical profiles.
Study Design This is a retrospective non-interventional study (Research Not Involving Human Subjects - RNIPH) using a before/after design in which each patient serves as their own control. All data are collected retrospectively from medical records and routine clinical assessments. Longitudinal data collected during standard care up to 3-5 years before surgery and 1-2 years after surgery are used to establish each patient's individual baseline trajectory and compare it to their post-operative evolution. This design controls for the high interindividual variability inherent to this population and renders a separate control group unnecessary.
Data are collected retrospectively from medical records and the existing occupational therapy database by Audrey COMBEY (occupational therapist). The database will then be locked and transmitted for statistical analysis to Julie ROZAIRE (research engineer).
Data Management and Confidentiality Data are pseudonymized using a participant code (inclusion number + 2 initials). The linkage table is maintained separately by the principal investigator and authorized collaborators on the Centre des Massues information system, protected by a secure password. The database is stored in a Microsoft Excel file on the internal server, accessible only to authorized collaborators. No data transfer to subcontractors is planned. Data will be retained for 3 years after study completion and archived for 15 years following the last publication.
Regulatory and Ethical Framework This study meets the definition of an "internal study" under French CNIL regulations, as it is conducted from data collected during routine patient follow-up, by the personnel providing that care, for their exclusive use. No individual participant information is required. The study is exempt from CNIL authorization and from the provisions of the Jardé Law (Law No. 2012-300 of March 5, 2012). The protocol is submitted for evaluation to the Internal Ethics Committee for Research (CIER) of the GHICL on May 19, 2026. In accordance with Article 30 of the GDPR, the study is registered in the data processing activities register of the Centre des Massues.
Statistical Analysis All participants meeting inclusion criteria will be included, representing approximately 70 patients. Descriptive statistics (means, standard deviations, medians, interquartile ranges, frequencies) will be computed for all variables. The primary and secondary outcomes will be analyzed using a before/after approach. For each outcome score, a linear mixed model (LMM) will be applied with fixed effects for period (before/after surgery) and measurement time, and a random patient effect to account for repeated measures correlation. Results will be reported with 95% confidence intervals. Holm correction will be applied systematically to limit type I error inflation. A significance threshold of 5% is used throughout. Statistical analyses will be performed using JASP 0.96.0 by Julie ROZAIRE.
Dissemination Results will be published in a peer-reviewed journal and presented at scientific society meetings (posters and/or oral communications).
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's planned enrollment of 70 is above the median of 63 across 465 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française is the lead sponsor of 11 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children with unilateral cerebral palsy (hemiplegia) who underwent individualized multisite neuro-orthopedic upper limb surgery at the Centre Médico-Chirurgical de Réadaptation des Massues between January 2012 and June 2025, with available pre- and post-operative functional assessments.
INCLUSION CRITERIA
NON-INCLUSION CRITERIA
Retrospective cohort of children with unilateral cerebral palsy (hemiplegia) who underwent individualized multisite neuro-orthopedic upper limb surgery at the Centre des Massues between January 2012 and June 2025. Surgical procedures were individualized and may include one or more of the following: short adductor of thumb release, flexor carpi ulnaris (FCU) release, FCU transfer to extensor carpi radialis brevis, finger flexor lengthening, round pronator release, elbow flexor lengthening, wrist arthrodesis, and other procedures. All patients underwent pre-surgical multidisciplinary evaluation, specialized surgery, and structured post-operative rehabilitation including orthoses and occupational therapy.
Upper Limb Range of Motion and Dexterity - Modified Melbourne Assessment (MA2)
Scores for the "Range of Motion" and "Dexterity" dimensions of the Modified Melbourne Assessment version 2 (MA2). The MA2 evaluates unilateral upper limb quality of function during tasks involving object approach, grasp, release, and manipulation in children aged 2.5 to 15 years with neurological impairment. Assessment is video-recorded during routine clinical care and scored retrospectively by an occupational therapist. Results are expressed as percentages for each of the four MA2 domains. Inter-rater reliability is excellent (R=0.95) and intra-rater reliability is very good (R=0.97).
Time frame: Data collected retrospectively up to 3 years (or 5 years if available) before surgery and up to 1 year (or 2 years if available) after surgery.
Unimanual Precision and Fluidity - Modified Melbourne Assessment (MA2)
Scores for the "Precision" and "Fluidity" dimensions of the Modified Melbourne Assessment version 2 (MA2), expressed as percentages. These dimensions characterize movement quality in terms of joint positioning accuracy and movement smoothness during standardized upper limb tasks.
Time frame: Data collected retrospectively up to 3 years (or 5 years if available) before surgery and up to 1 year (or 2 years if available) after surgery.
Global Manual Dexterity - Box and Block Test (BBT)
Raw score of the Box and Block Test (BBT): the number of wooden cubes (2.5 cm) that the child can transfer one at a time from one compartment to the other of a divided box in 1 minute. Assessed for each hand separately. A standardized and normed test for children from age 6, used to quantify gross manual dexterity as a complement to the Melbourne Assessment.
Time frame: Data collected retrospectively up to 3 years (or 5 years if available) before surgery and up to 1 year (or 2 years if available) after surgery.
Bimanual Performance - Assisting Hand Assessment (AHA)
Total score of the Assisting Hand Assessment version 5.0 (AHA), expressed on an interval scale from 0 to 100 AHA units. The AHA evaluates the effectiveness of the assisting hand in bimanual performance in children aged 18 months to 18 years with unilateral impairment. Assessment is video-recorded during a structured play session (standardized toys, board game, or activity of daily living adapted to age), scored by a trained occupational therapist on 20 items rated 1 (ineffective) to 4 (effective). A difference of 5 AHA units is considered clinically significant. Inter-rater reliability is excellent (ICC=0.98).
Time frame: Data collected retrospectively up to 3 years (or 5 years if available) before surgery and up to 1 year (or 2 years if available) after surgery.
Patient and Parent Satisfaction with Surgical Outcomes - Goal Attainment
Child/parent satisfaction regarding attainment of the individualized surgical goal, assessed on a 5-point Likert scale: not at all satisfied, slightly satisfied, moderately satisfied, satisfied, very satisfied. Collected during the scheduled follow-up consultation.
Time frame: Postoperative assessment, between 12 and 36 months after surgery
Overall Patient and Parent Satisfaction with Surgical Treatment
Overall satisfaction of children/parents regarding the surgical treatment, assessed via a structured satisfaction questionnaire administered by email at distance from surgery. The questionnaire includes a numerical satisfaction scale (0-10) for pain, activities of daily living, aesthetics, and motor function; a global satisfaction item compared to expectations; and questions about decision-making regarding the surgical pathway timing.
Time frame: minimum 12 months post-surgery, assessed through study completion
Correlation Between Age at Surgery and Change in Manual Ability (MA2 Score)
Pearson or Spearman correlation between age at time of surgery (in years) and the change in MA2 score (score difference between pre-surgical baseline and end of observation period), assessed using the Manual Ability Assessment 2 (MA2) scale.
Time frame: Age collected at baseline; MA2 at baseline (last MA2 score before surgery) and first postoperative MA2 score, an average of 12 months after surgery
Correlation Between Presence of Associated Cognitive Impairments and Change in Manual Ability (MA2 Score)
Point-biserial correlation between presence vs. absence of associated cognitive impairments (binary variable, yes/no, assessed via clinical evaluation) and the change in MA2 score between pre-surgical baseline and end of observation period, measured using the MA2 scale.
Time frame: Cognitive impairment status collected at baseline; MA2 at baseline (last MA2 score before surgery) and first postoperative MA2 score, an average of 12 months after surgery
Correlation Between Presence of Associated Sensory Impairments and Change in Manual Ability (MA2 Score)
Point-biserial correlation between presence vs. absence of associated sensory impairments (binary variable, yes/no, assessed via clinical evaluation) and the change in MA2 score between pre-surgical baseline and end of observation period, measured using the MA2 scale.
Time frame: Sensory impairment status collected at baseline; MA2 at baseline (last MA2 score before surgery) and first postoperative MA2 score, an average of 12 months after surgery
Correlation Between Pre-Surgical Zancolli Classification and Change in Manual Ability (MA2 Score)
Spearman correlation between pre-surgical Zancolli classification (ordinal scale assessing wrist and finger flexor function, categories I to III) and the change in MA2 score between pre-surgical baseline and end of observation period, measured using the MA2 scale.
Time frame: Zancolli classification collected at baseline; MA2 score change pre and post surgery
Correlation Between Pre-Surgical Corry Classification and Change in Manual Ability (MA2 Score)
Spearman correlation between pre-surgical Corry classification (ordinal scale assessing spasticity patterns of the upper limb, categories I to IV) and the change in MA2 score between pre-surgical baseline and end of observation period, measured using the MA2 scale.
Time frame: Corry classification collected at baseline; MA2 score change pre and post surgery
Correlation Between Pre-Surgical AHA Score and Change in Manual Ability (MA2 Score)
Pearson or Spearman correlation between the pre-surgical Assisting Hand Assessment (AHA) score (a standardized scale measuring how effectively children with unilateral upper limb impairment use their affected hand in bimanual activities, scored 0-100) and the change in MA2 score between pre-surgical baseline and end of observation period, measured using the MA2 scale.
Time frame: AHA score collected at baseline; MA2 at baseline (last MA2 score before surgery) and first postoperative MA2 score, an average of 12 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2026 to primary completion in Sep 2026, 2 months.
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française