Effect of HABIT-ILE on the Body Function and Structures of Children With Cerebral Palsy
NCT04403490, Not applicable, Unknown, Université Catholique de Louvain
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of HABIT-ILE on the Body Function and Structures of Children With Cerebral Palsy | ClinicalTrials.gov |
| NCT number | NCT04403490 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Université Catholique de Louvain | ClinicalTrials.gov |
| Conditions | Cerebral Palsy | ClinicalTrials.gov |
| Interventions | HABIT-ILE, Conventional intervention | ClinicalTrials.gov |
| First posted | 2020-05-27 | ClinicalTrials.gov |
| Last updated | 2022-06-15 | ClinicalTrials.gov |
Registered outcomes 30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in Diffusion Tensor Imaging (DTI) | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | This sequence allows to measure changes in the fractional anisotropy (FA) on the white matter tracts. FA is a scalar value (no unit) between zero and one that describes the degree of anisotropy of white matter water molecules. | ClinicalTrials.gov |
| Primary | Changes in Test of Arm Selective Control (TASC) | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The TASC is an upper limb selective motor control evaluation tool including eight motions in each arm and up to three attempts are allowed for each motion. This assessment tool was developed in 2010 and Sukal-Moulton et al. have proved its validity and reliability for children with CP in 2017. After completion of the best attempt, points ranging from 0 (absent), 1 (impaired) to 2 (normal) are recorded for each joint depending on the movement properties and descriptors of the test. | ClinicalTrials.gov |
| Primary | Changes in Selective Control Assessment of the Lower Extremity (SCALE): | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The SCALE was designed to evaluate lower limb selective motor control of children with cerebral palsy. The SCALE includes testing of five reciprocal lower extremity movements. SVMC is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points). | ClinicalTrials.gov |
| Primary | Changes in Strength | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The strength will be measured for main muscle groups using a Microfet. | ClinicalTrials.gov |
| Primary | Changes in Stiffness | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The stiffness will be measured using a device developed and already validated at UCLouvain. | ClinicalTrials.gov |
| Secondary | Changes in Assisting Hand Assessment (AHA or BoHA) | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The AHA is a videotaped tool measuring how effectively children with unilateral CP use the affected hand in bimanual activities. The BoHA is a videotaped tool measuring how effectively children with bilateral CP use both hands in bimanual activities. | ClinicalTrials.gov |
| Secondary | Changes in ABILHAND-Kids Questionnaire | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The ABILHAND-Kids Questionnaire has been developed to assess a child's unimanual and bimanual upper limb activities. It ranges from - 6 to +6 logits (higher score means better performance). | ClinicalTrials.gov |
| Secondary | Changes in ACTIVLIM-CP Questionnaire | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The ACTIVLIM-CP Questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or the lower limbs through 42 items specific to patients with cerebral palsy. It ranges from - 5 to +5 logits (higher score means better performance). | ClinicalTrials.gov |
| Secondary | Changes in Gross Motor Function Measurement (GMFM 66) | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy. | ClinicalTrials.gov |
| Secondary | Changes in 6 Minutes Walking Test (6MWT) | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The 6 Minutes Walking Test measures the distance that the patient walk as much as possible within a period of 6-minutes in a 30 meters long corridor. | ClinicalTrials.gov |
| Secondary | Changes in Box and Blocks test | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The BBT is a test of gross manual dexterity. Each hand is tested individually and the BBT is scored through the number of blocks carried over the partition from one part to another part of a box during the one-minute trial period. | ClinicalTrials.gov |
| Secondary | Changes in Jebsen-Taylor Test | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The Jebsen-Taylor Test assesses uni-manual hand function, through 7 subtests simulating daily life activities. The test assesses speed, not quality of performance and time to complete each activity is reported using a stopwatch. | ClinicalTrials.gov |
| Secondary | Changes in Modified Cooper test | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The Modified Cooper test is a modified version of The Manual Form Perception Test, which evaluates stereognosis through 16 objects. Both hands are tested separately and time to recognise the objects is reported using a stopwatch. | ClinicalTrials.gov |
| Secondary | Changes in ABILOCO-Kids Questionnaire | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The ABILOCO-Kids Questionnaire measures a patient's ability to perform daily activities requiring the use of the lower limbs through 10 items specific to patients with cerebral palsy. It ranges from - 4 to +4 logits (higher score means better performance). | ClinicalTrials.gov |
| Secondary | Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The PEDI-CAT is the new version of the Pediatric Evaluation of Disability Inventory (PEDI). The PEDI-CAT is comprised of 276 functional activities acquired throughout infancy, childhood and young adulthood. Based on the nternational Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) model, the PEDI-CAT contents provide information about the activities and participation component. It ranges from 0 to 100% (higher score means better performance). | ClinicalTrials.gov |
| Secondary | Changes in Canadian Occupational Performance Measure (COPM) | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The COPM measures the patient's self-perception of occupational performance and satisfaction of it in daily activities over time. It ranges from 1 to 10, a higher score means a better performance. | ClinicalTrials.gov |
| Secondary | Changes in Double Inversion Recovery (DIR) | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | This sequence allows to identify an inflamatory lesion. | ClinicalTrials.gov |
| Secondary | Changes in Functional resting state (RS) | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | This sequence allows to evaluate the regional interactions that occur in a resting or task-negative state. | ClinicalTrials.gov |
| Secondary | Changes in T1-weighted and T2-weighted structural imaging | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | The difference between these sequences allows to evaluated changes in the cortical myelin. | ClinicalTrials.gov |
| Secondary | Changes in Executive Functions | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | Cognitive functions of the children will be assessed by Stroop task and Flanker task. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Eriksen Flanker Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)