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出境医 / 临床实验 / Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy (EarlyHABIT-ILE)

Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy (EarlyHABIT-ILE)

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Behavioral: HABIT-ILE Behavioral: Usual Care Not Applicable

Detailed Description:
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional, Neuroplastic and Biomechanical Changes Induced by Early Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Pre-school Children With Uni- and Bilateral Cerebral Palsy
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: HABIT-ILE
Early HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.
Behavioral: HABIT-ILE
Early Hand and arm bimanual intensive therapy including lower extremities

Active Comparator: Usual Care
A two weeks period of usual customary care
Behavioral: Usual Care
Usual customary care

Outcome Measures
Primary Outcome Measures :
  1. Change on Gross Motor Function (GMFM-66) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up. ]
    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)

  2. Change on Manual Ability (Assisting Hand Assessment (AHA)) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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)


Secondary Outcome Measures :
  1. Melbourne 2 Assessment (MA2) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    assess the unilateral performance of the upper extremities, quantifying the dexterity, fluency, accuracy and range of movement during several tasks of reaching and manipulation

  2. Inhibitory control task [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.

  3. Working memory task [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.

  4. Visuo-spatial attention assessment [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    Through different simple tasks, measures the visual field, the visuo-motor coordination, the orientation of attention in the space and the eye pursuit.

  5. Semmes-Weinstein monofilaments [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.

  6. Pressure Threshold [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.

  7. Activlim-CP questionnaire [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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).

  8. Pediatric Evaluation of Disability Inventory questionnaire (PEDI) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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).

  9. Young children's participation and environment measure (YC-PEM) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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).

  10. Measure of Processes of Care (MPOC-20) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]

    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.


  11. Canadian Occupational Performance Measure (COPM) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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)

  12. 3D T1-weighted structural imaging (T1) [ Time Frame: pre-camp, 3 months follow-up ]
    This sequence allows to measure changes in gray matter (cortical thickness)

  13. Changes on the Fractional Anisotropy (Diffusion tensor imaging (DTI)) [ Time Frame: pre-camp, 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.

  14. Changes on the Mean Diffusivity (Diffusion tensor imaging (DTI)) [ Time Frame: pre-camp, 3 months follow-up ]
    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.

  15. Changes on resting state functional connectivity (RS) [ Time Frame: pre-camp, 3 months follow-up ]
    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

  16. Changes on spatial parameters of the gait (Kinematics assessments) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the stride length (meters), step length (meters) and step width (meters).

  17. Changes on temporal parameters of the gait (Cycle time) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure cycle of gait time (seconds).

  18. Changes on temporal parameters of the gait (Stance time) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the stance time (percentage of total gait cycle).

  19. Changes on temporal parameters of the gait (Swing time) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the swing time (percentage of total gait cycle).

  20. Changes on temporal parameters of the gait (Stride) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the gait cadence (stride per minute).

  21. Changes on temporal parameters of the gait (Velocity) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the gait velocity (meter/second)

  22. Changes on temporal parameters of the gait (Acceleration) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the gait acceleration (meters/second^2)

  23. Changes on spatial parameters of the upper extremity (Straightness) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the straightness (percentage of upper extremity trajectory during a reaching task).

  24. Changes on spatial parameters of the upper extremity (Smoothness) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the smoothness (variability of the movement during a reaching task)

  25. Changes on temporal parameters of the upper extremity (Kinematics assessments) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the time from onset to end of the task (seconds). the task consist in a reaching task.

  26. Quantification of physical activity [ Time Frame: 5 hours during 5 consecutive days ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   12 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with unilateral or bilateral cerebral palsy (spastic or dyskinetic)
  • age 1 to 4 years inclusive (corrected age if preterm birth)
  • ability to follow instructions and complete testing according to the age.

Exclusion Criteria:

  • active seizure
  • programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
  • severe visual impairments
  • severe cognitive impairments
  • contraindications to perform MRI assessments (Metal implants, etc.)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Yannick Bleyenheuft, PhD +3227645446 yannick.bleyenheuft@uclouvain.be
Contact: Rodrigo Araneda, PhD +3227645446 rodrigo.araneda@uclouvain.be

Locations
Layout table for location information
Belgium
Institute of Neuroscience, Université catholique de Louvain Recruiting
Brussels, Belgium, 1200
Contact: Yannick Bleyenheuft, Pr       yannick.bleyenheuft@uclouvain.be   
France
Fondation ILDYS - Site de Ty Yann Recruiting
Brest, France
Contact: Sylvain BROCHARD, PH    +33298442021    sylvain.brochard@chu-brest.fr   
Italy
IRCCS Fondazione Stella Maris Recruiting
Marina Di Pisa-Tirrenia-Calambrone, Toscana, Italy, 56128
Contact: Andrea Guzzetta, MD, PhD       aguzzetta@fsm.unipi.it   
Sponsors and Collaborators
Université Catholique de Louvain
University Hospital, Brest
University of Pisa
University Hospital, Angers
University of Lausanne Hospitals
University of the Balearic Islands
Fondation Paralysie Cérébrale
Investigators
Layout table for investigator information
Principal Investigator: Yannick Bleyenheuft, Pr MSL-IN Lab, Institute of Neuroscience, Université catholique de Louvain
Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date November 24, 2020
Actual Study Start Date  ICMJE November 27, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • Change on Gross Motor Function (GMFM-66) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up. ]
    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)
  • Change on Manual Ability (Assisting Hand Assessment (AHA)) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • Change on Gross Motor Function (GMFM-66) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up. ]
    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 RCT2
  • Change on Manual Ability (Assisting Hand Assessment (AHA)) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    Developed to observe the efficacy of the assisting hand use, in children with unilateral cerebral palsy (scored in percentage), during bimanual activities for the RCT1
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • Melbourne 2 Assessment (MA2) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    assess the unilateral performance of the upper extremities, quantifying the dexterity, fluency, accuracy and range of movement during several tasks of reaching and manipulation
  • Inhibitory control task [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • Working memory task [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • Visuo-spatial attention assessment [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    Through different simple tasks, measures the visual field, the visuo-motor coordination, the orientation of attention in the space and the eye pursuit.
  • Semmes-Weinstein monofilaments [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • Pressure Threshold [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • Activlim-CP questionnaire [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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).
  • Pediatric Evaluation of Disability Inventory questionnaire (PEDI) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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).
  • Young children's participation and environment measure (YC-PEM) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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).
  • Measure of Processes of Care (MPOC-20) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • Canadian Occupational Performance Measure (COPM) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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)
  • 3D T1-weighted structural imaging (T1) [ Time Frame: pre-camp, 3 months follow-up ]
    This sequence allows to measure changes in gray matter (cortical thickness)
  • Changes on the Fractional Anisotropy (Diffusion tensor imaging (DTI)) [ Time Frame: pre-camp, 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.
  • Changes on the Mean Diffusivity (Diffusion tensor imaging (DTI)) [ Time Frame: pre-camp, 3 months follow-up ]
    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.
  • Changes on resting state functional connectivity (RS) [ Time Frame: pre-camp, 3 months follow-up ]
    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
  • Changes on spatial parameters of the gait (Kinematics assessments) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the stride length (meters), step length (meters) and step width (meters).
  • Changes on temporal parameters of the gait (Cycle time) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure cycle of gait time (seconds).
  • Changes on temporal parameters of the gait (Stance time) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the stance time (percentage of total gait cycle).
  • Changes on temporal parameters of the gait (Swing time) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the swing time (percentage of total gait cycle).
  • Changes on temporal parameters of the gait (Stride) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the gait cadence (stride per minute).
  • Changes on temporal parameters of the gait (Velocity) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the gait velocity (meter/second)
  • Changes on temporal parameters of the gait (Acceleration) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the gait acceleration (meters/second^2)
  • Changes on spatial parameters of the upper extremity (Straightness) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the straightness (percentage of upper extremity trajectory during a reaching task).
  • Changes on spatial parameters of the upper extremity (Smoothness) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the smoothness (variability of the movement during a reaching task)
  • Changes on temporal parameters of the upper extremity (Kinematics assessments) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the time from onset to end of the task (seconds). the task consist in a reaching task.
  • Quantification of physical activity [ Time Frame: 5 hours during 5 consecutive days ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • Melbourne 2 Assessment (MA2) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    assess the unilateral performance of the upper extremities, quantifying the dexterity, fluency, accuracy and range of movement during several tasks of reaching and manipulation
  • Inhibitory control task [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • Working memory task [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • Visuo-spatial attention assessment [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    Through different simple tasks, measures the visual field, the visuo-motor coordination, the orientation of attention in the space and the eye pursuit.
  • Semmes-Weinstein monofilaments [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • Pressure Threshold [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • Activlim-CP questionnaire [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    Measures performance of the child in daily life activities focusing on upper and lower extremities.
  • Pediatric Evaluation of Disability Inventory questionnaire (PEDI) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • Young children's participation and environment measure (YC-PEM) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    Based in different children's activities, this questionnaire evaluates the level of participation and the quality of the environment in which these activities take place.
  • Measure of Processes of Care (MPOC) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    Assesses the parents' perceptions of the care they and their children receive from children's rehabilitation treatment centres.
  • Canadian Occupational Performance Measure (COPM) [ Time Frame: pre-camp, two weeks post-camp, 3 months follow-up ]
    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.
  • 3D T1-weighted structural imaging (T1) [ Time Frame: pre-camp, 3 months follow-up ]
    This sequence allows to measure changes in gray matter (cortical thickness)
  • Changes on the Fractional Anisotropy (Diffusion tensor imaging (DTI)) [ Time Frame: pre-camp, 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.
  • Changes on the Mean Diffusivity (Diffusion tensor imaging (DTI)) [ Time Frame: pre-camp, 3 months follow-up ]
    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.
  • Functional resting state (RS) [ Time Frame: pre-camp, 3 months follow-up ]
    This sequence allows to evaluates the regional interactions that occur in a resting or task-negative state.
  • Changes on spatial parameters of the gait (Kinematics assessments) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the stride length (meters), step length (meters) and step width (meters).
  • Changes on temporal parameters of the gait (Cycle time) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure cycle of gait time (seconds).
  • Changes on temporal parameters of the gait (Stance time) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the stance time (percentage of total gait cycle).
  • Changes on temporal parameters of the gait (Swing time) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the swing time (percentage of total gait cycle).
  • Changes on temporal parameters of the gait (Stride) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the gait cadence (stride per minute).
  • Changes on temporal parameters of the gait (Velocity) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the gait velocity (meter/second)
  • Changes on temporal parameters of the gait (Acceleration) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the gait acceleration (meters/second^2)
  • Changes on spatial parameters of the upper extremity (Straightness) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the straightness (percentage of upper extremity trajectory during a reaching task).
  • Changes on spatial parameters of the upper extremity (Smoothness) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the smoothness (variability of the movement during a reaching task)
  • Changes on temporal parameters of the upper extremity (Kinematics assessments) [ Time Frame: pre-camp, 3 months follow-up ]
    Through a 3D motion system, we measure the time from onset to end of the task (seconds). the task consist in a reaching task.
  • Quantification of physical activity [ Time Frame: 5 hours during 5 consecutive days ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy
Official Title  ICMJE Functional, Neuroplastic and Biomechanical Changes Induced by Early Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Pre-school Children With Uni- and Bilateral Cerebral Palsy
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE
  • Behavioral: HABIT-ILE
    Early Hand and arm bimanual intensive therapy including lower extremities
  • Behavioral: Usual Care
    Usual customary care
Study Arms  ICMJE
  • Experimental: HABIT-ILE
    Early HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.
    Intervention: Behavioral: HABIT-ILE
  • Active Comparator: Usual Care
    A two weeks period of usual customary care
    Intervention: Behavioral: Usual Care
Publications * Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y; Early HABIT-ILE group. Functional, neuroplastic and biomechanical changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with unilateral cerebral palsy: study protocol of a randomized control trial. BMC Neurol. 2020 Apr 14;20(1):133. doi: 10.1186/s12883-020-01705-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • children with unilateral or bilateral cerebral palsy (spastic or dyskinetic)
  • age 1 to 4 years inclusive (corrected age if preterm birth)
  • ability to follow instructions and complete testing according to the age.

Exclusion Criteria:

  • active seizure
  • programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
  • severe visual impairments
  • severe cognitive impairments
  • contraindications to perform MRI assessments (Metal implants, etc.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yannick Bleyenheuft, PhD +3227645446 yannick.bleyenheuft@uclouvain.be
Contact: Rodrigo Araneda, PhD +3227645446 rodrigo.araneda@uclouvain.be
Listed Location Countries  ICMJE Belgium,   France,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020354
Other Study ID Numbers  ICMJE B403201316810d
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yannick Bleyenheuft, Université Catholique de Louvain
Study Sponsor  ICMJE Université Catholique de Louvain
Collaborators  ICMJE
  • University Hospital, Brest
  • University of Pisa
  • University Hospital, Angers
  • University of Lausanne Hospitals
  • University of the Balearic Islands
  • Fondation Paralysie Cérébrale
Investigators  ICMJE
Principal Investigator: Yannick Bleyenheuft, Pr MSL-IN Lab, Institute of Neuroscience, Université catholique de Louvain
PRS Account Université Catholique de Louvain
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP