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Trial · NCT07889622

Effects and Feasibility of a HABIT-ILE and a Home Program on the Bimanual Performance of Children With Cerebral Palsy

NCT07889622, Completed, Fondation Ildys

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effects and Feasibility of a HABIT-ILE and a Home Program on the Bimanual Performance of Children With Cerebral Palsy. Trials, record NCT07889622. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07889622

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effects and Feasibility of a HABIT-ILE and a Home Program on the Bimanual Performance of Children With Cerebral Palsy
NCT number
NCT07889622
Status
Completed
Enrollment
14 participants, actual
Lead sponsor
Fondation Ildys
Conditions
Cerebral Palsy (CP)
Interventions
Behavioral
First posted
2026-10-22
Last updated
2026-10-22

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPDMS-2pre-camp, two weeks post-camp, 3 months follow-up
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.
SecondaryAHApre-camp, two weeks post-camp, 3 months follow-up
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.
SecondaryFeasibilityDuring the camp, 3 months follow up
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.
SecondaryThe empowerment of parentspre-camp, 3 months follow-up.
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.
SecondaryCOPMpre-camp, two weeks post-camp, 3 months follow-up
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).

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
17376135BACKGROUNDPubMed
19841839BACKGROUNDPubMed
32491226BACKGROUNDPubMed
34950076BACKGROUNDPubMed
36615077BACKGROUNDPubMed
37930692BACKGROUNDPubMed
38050486BACKGROUNDPubMed
38083836BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07889622

GET https://conductscience.org/api/trials/v1/NCT07889622/registered