An observational study in Cerebral Palsy (CP), sponsored by Fondation Ildys. Completed at 1 site in France. Open to participants aged 24 Months to 71 Months. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Fondation Ildys · Observational
This single arm double baseline study explored the efficacy and feasibility of the PARTNER program (30h HABIT-ILE + 10h home program) on the functional changes and families' resources of 14 children with unilateral CP aged 24 to 71 months.
This single-arm, double-baseline study evaluated the feasibility and efficacy of a combined 30-hour HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) clinic-based intervention and a 10-hour structured home program for children with unilateral cerebral palsy aged 24 to 71 months yo.
The primary outcome was the PDMS-2, assessing gross and fine motor performance. Secondary outcomes included the Assisting Hand Assessment (AHA) for bimanual performance, the Canadian Occupational Performance Measure (COPM) for functional goals, and family-centered measures: the Psychological Empowerment Scale (PES), the Enabling Practices Scal, and Client Satisfaction Questionnaire (CSQ-8) for global satisfaction.
The clinical rehabilitation protocol included two initial assessments (conducted 14 days apart and prior to the motor intervention) to jointly determine the goals with the family. These assessments were followed by a two-week intervention phase (HABIT-ILE + home-based activities). The post-intervention and three-month follow-up assessments allowed for the sharing of follow-up information with the family and also for the evaluation of the immediate and short-term effects of the intervention. The feasibility of the intervention was assessed using adherence rates (on-site intervention and home program), the three-month retention rate, and family satisfaction.
The scientific evaluation of the data from this clinical protocol aimed to provide preliminary evidence for the combined approach while refining protocols for a future randomized controlled trial.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's enrollment of 14 is below the median of 63 across 465 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Fondation Ildys is the lead sponsor of 17 studies on the registry; 8 are open to participants now.
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Children aged 24 to 71 months (corrected age) with physician-confirmed unilateral cerebral palsy were eligible. Participants were required to demonstrate minimal upper limb function in the affected hand, defined as the ability to grasp a light object and lift it at least 15 cm above a table surface. Cognitive and communicative abilities sufficient to understand instructions and complete all assessments were also required. Children with ataxic CP, uncontrolled epilepsy, or significant visual or auditory deficits likely to interfere with participation were excluded. To ensure treatment stability, children who had received botulinum toxin injections or undergone surgery within the 6 months prior to enrolment, or for whom such procedures were planned during the study period, were also excluded. Family commitment was required, with written informed consent obtained from a parent or legal guardian who agreed to participate consistently throughout the study.
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Exclusion Criteria:
Subjects received 30 hours of HABIT-ILE clinic-based intervention 3h/day, 5 days/week and 10 hours of home program 1h/day, 5 day/week. These two procedures were performed concurrently over a 2-week period.
Other: Behavioral
Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities. - Home program with parental coaching
PDMS-2
The primary outcome was the difference in PDMS-2 score changes between the usual care control and PARTNER intervention periods. The PDMS-2 is a standardized, norm-referenced tool assessing motor development in children aged 0-5 years, with demonstrated reliability and responsiveness in young children with cerebral palsy (CP). It includes six subtests evaluating gross and fine motor skills. Raw scores are converted into age-standardized scores to calculate the Total Motor Quotient (TMQ), Fine Motor Quotient (FMQ), and Gross Motor Quotient (GMQ). The TMQ provides an overall measure of motor competence, classified as average (90-110), below average (80-89), poor (70-79), or very poor (35-69). FMQ and GMQ assess fine and gross motor performance relative to age-matched peers. In children aged 27-64 months with CP, responsiveness ranged from 1.7 to 2.3 across the three composite scores.
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
AHA
The Assisting Hand Assessment (AHA) is a valid and reliable measure of bimanual performance, assessing the contribution of the most affected hand. Developed for children with unilateral cerebral palsy (CP) aged 18 months to 12 years, it is the gold standard in clinical practice and research. Raw scores are converted to a 0-100 logit scale using a Rasch model and conversion table. Its Smallest Detectable Difference (SDD) is 3.89.
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Feasibility
Protocol feasibility will be assessed using a traffic-light system based on predefined criteria (Davis et al.). (1) On-site intervention completion: green, ≥90% of children complete ≥90% of the 30 hours; amber, 70-89% complete ≥90%, or ≥90% complete 70-89%; red, \<70% complete ≤70%. (2) Home intervention completion: green, ≥90% of families complete \>90% of the 10 hours; amber, 70-89% complete ≥90%, or ≥90% complete 70-89%; red, \<70% complete ≤70%. (3) Three-month retention: green, ≥90% return; amber, 70-89%; red, \<70%. (4) Family satisfaction: green, ≥90% of families report ≥90% satisfaction; amber, 70-89%; red, ≤70%, measured using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Feasibility will be confirmed if all criteria are green; amber results will require protocol adjustments, while any red result will prevent progression to the main trial.
Time frame: During the camp, 3 months follow up
The empowerment of parents
Parental empowerment refers to parents' ability to act confidently, take control and advocate for their child's needs within healthcare and support systems to improve family quality of life. The Psychological Empowerment Scale (PES) measures parents' perceived empowerment; the overall score will be used. We hypothesize that active participation in the PARTNER program, through problem-solving and support for children's motor development, will strengthen family empowerment. Parental enabling refers to professionals' practices that promote parents' active involvement, informed decision-making and skill development in their child's care. Unlike empowerment, which reflects parents' internal sense of control and agency, enabling concerns the external, professional-driven conditions that facilitate engagement. The Enabling Practices Scale (EPS) assesses parents' perceptions of these practices.
Time frame: pre-camp, 3 months follow-up.
COPM
The Canadian Occupational Performance Measure (COPM) is a semi-structured interview used to define therapeutic goals and assess children's performance and parents' satisfaction. Following Cuzick et al., "paid/unpaid work" and "household management" were excluded. Parents identified five priority needs and rated their child's performance (COPMp) and their satisfaction (COPMs). Although the minimal clinically important difference (MCID) is commonly set at 2 points, Cuzick et al. reported a mean overall score change of 2.85 points (median 2.84).
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Plan to share: No
Ran from Mar 2022 to primary completion in Sep 2023, 18 months.
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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 ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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