An interventional study of HABIT-ILE and Usual Care in Cerebral Palsy, sponsored by Université Catholique de Louvain. Status unknown at 3 sites in 3 countries. Open to participants aged 12 Months to 59 Months. Per ClinicalTrials.gov, last updated 2022-05-25.
Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Treatment
Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.
This study aims to evaluate the effect of two weeks of early Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on bimanual performance in pre-school children with unilateral cerebral palsy (CP) and on gross motor function in those with bilateral CP, compared with two weeks of usual motor activity including usual rehabilitation (control group). We will assess further changes in unilateral performance tests, daily life activities questionnaires and executive function tests. Neuroplastic changes will be assessed using brain imaging (magnetic resonance imaging, MRI) and biomechanical changes will be assessed by using optoelectronic motion capture system with electromyography (EMG), to determine the effect of HABIT-ILE on movement pattern and quality.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's planned enrollment of 100 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Université Catholique de Louvain is the lead sponsor of 151 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
Early HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.
Behavioral: HABIT-ILE
A two weeks period of usual customary care
Behavioral: Usual Care
Early Hand and arm bimanual intensive therapy including lower extremities
Usual customary care
Change on Gross Motor Function (GMFM-66)
Developed to assess the changes in gross motor function of children with cerebral palsy (scored in percentage), observed over time or after intervention for the second randomized controlled trial (RCT2)
Time frame: pre-camp, two weeks post-camp, 3 months follow-up.
Change on Manual Ability (Assisting Hand Assessment (AHA))
Developed to observe the efficacy of the assisting hand use, in children with unilateral cerebral palsy (scored in percentage), during bimanual activities for the first randomized controlled trial (RCT1)
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Melbourne 2 Assessment (MA2)
assess the unilateral performance of the upper extremities, quantifying the dexterity, fluency, accuracy and range of movement during several tasks of reaching and manipulation
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Inhibitory control task
Measures the inhibition of a motor answer. It's assessed by asking the child not to reach for a toy previously showed to play with. The maximum waiting time is 30 seconds.
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Working memory task
Measures the capacity to retain visual information in use, in a short period of time. It's assessed by hiding a toy in front of the child and asking him/her to find it from 4 possibilities.
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Visuo-spatial attention assessment
Through different simple tasks, measures the visual field, the visuo-motor coordination, the orientation of attention in the space and the eye pursuit.
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Semmes-Weinstein monofilaments
Evaluates the pressure threshold or the response to a touching sensation of the filament. It is quantified using a numerical grading ranging from high pression/clear touching sensation to a slight pression/slight touching sensation.
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Pressure Threshold
The superior pressure threshold will be determined at the moment of any visible change in the child's reaction to the pression made by the algometer.
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Activlim-CP questionnaire
This parent's filled questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or the lower extremities through 43 items specific to patients with cerebral palsy. It ranges from - 7 to +7 logits (higher score means better performance).
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Pediatric Evaluation of Disability Inventory questionnaire (PEDI)
This parent's filled questionnaire measures the performance of the child in the daily life activities and movement domains, focusing on the capacity of upper extremities and lower extremities during this activities. It ranges from 0 to 100% (higher score means better performance).
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Young children's participation and environment measure (YC-PEM)
Based in different children's activities, this parent's filled questionnaire evaluates the level of participation and the quality of the environment in which these activities take place. For each type of activity, caregivers assess 3 dimensions of the child's participation: frequency (8-point scale; 0-7), level of involvement (5-point scale; 1-5), caregiver's percent desire for change (2-points level (y/n) transformed in percentage; 0-100) and perceived impact of environmental support (3-point scale transformed in percentage; 0-100). A software calculates the total score with a maximum of 212 (higher score means better performance).
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Measure of Processes of Care (MPOC-20)
Assesses the parents' perceptions of the care they and their children receive from children's rehabilitation treatment centres. Using a 8-point response scale, parents answer to 20 questions, indicating to what extent they have experienced the events or the situations described. A score of 7 means that they have experienced this aspect to a very great extent, or most of the time. A score of 1 means that they have not experienced this aspect at all. A score of 0 means that the question does not apply to them. There is no total score. However, because the statements are positively worded, higher total scores indicates that needs of the parents are being met to a great extent.
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
Canadian Occupational Performance Measure (COPM)
This is an interview-setting designed to capture a patient's self-perception of performance and satisfaction of it in everyday activities, observed over time. During the interview, parents set up 5 activities considered difficult in daily life. These are then assessed, in a 1 to 10 scale, regarding the child's self-perception of performance and satisfaction of it. The total score is the average of the scores for perception and satisfaction separately (score from 1 to 10; higher score means better performance/satisfaction)
Time frame: pre-camp, two weeks post-camp, 3 months follow-up
3D T1-weighted structural imaging (T1)
This sequence allows to measure changes in gray matter (cortical thickness)
Time frame: pre-camp, 3 months follow-up
Changes on the Fractional Anisotropy (Diffusion tensor imaging (DTI))
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.
Time frame: pre-camp, 3 months follow-up
Changes on the Mean Diffusivity (Diffusion tensor imaging (DTI))
This sequence allows to measure the mean changes in the diffusivity (MD). MD is a scalar value (no unit) between zero and one that describes the degree of molecular diffusion.
Time frame: pre-camp, 3 months follow-up
Changes on resting state functional connectivity (RS)
Resting-state functional magnetic resonane imaging (rs-fMRI) evaluates the regional interactions that occur during the resting or task-negative state. The magnitud of the brain activation during rs-fMRI will be assessed
Time frame: pre-camp, 3 months follow-up
Changes on spatial parameters of the gait (Kinematics assessments)
Through a 3D motion system, we measure the stride length (meters), step length (meters) and step width (meters).
Time frame: pre-camp, 3 months follow-up
Changes on temporal parameters of the gait (Cycle time)
Through a 3D motion system, we measure cycle of gait time (seconds).
Time frame: pre-camp, 3 months follow-up
Changes on temporal parameters of the gait (Stance time)
Through a 3D motion system, we measure the stance time (percentage of total gait cycle).
Time frame: pre-camp, 3 months follow-up
Changes on temporal parameters of the gait (Swing time)
Through a 3D motion system, we measure the swing time (percentage of total gait cycle).
Time frame: pre-camp, 3 months follow-up
Changes on temporal parameters of the gait (Stride)
Through a 3D motion system, we measure the gait cadence (stride per minute).
Time frame: pre-camp, 3 months follow-up
Changes on temporal parameters of the gait (Velocity)
Through a 3D motion system, we measure the gait velocity (meter/second)
Time frame: pre-camp, 3 months follow-up
Changes on temporal parameters of the gait (Acceleration)
Through a 3D motion system, we measure the gait acceleration (meters/second\^2)
Time frame: pre-camp, 3 months follow-up
Changes on spatial parameters of the upper extremity (Straightness)
Through a 3D motion system, we measure the straightness (percentage of upper extremity trajectory during a reaching task).
Time frame: pre-camp, 3 months follow-up
Changes on spatial parameters of the upper extremity (Smoothness)
Through a 3D motion system, we measure the smoothness (variability of the movement during a reaching task)
Time frame: pre-camp, 3 months follow-up
Changes on temporal parameters of the upper extremity (Kinematics assessments)
Through a 3D motion system, we measure the time from onset to end of the task (seconds). the task consist in a reaching task.
Time frame: pre-camp, 3 months follow-up
Quantification of physical activity
With a movement sensor on each wrist, the percentage of total time spent in movement (i.e. crawling, walking and running) is measured. Calculated in terms of the changes in the acceleration (m/s\^2). These measurements will be performed during therapy in 5 consecutive days for the HABIT-ILE group and during a regular week for the Usual Care group.
Time frame: 5 hours during 5 consecutive days
Plan to share: No
Ran from Nov 2018 to primary completion in Dec 2021, 37 months.
Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 37 months is above that.
Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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