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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: HABIT-ILE; Behavioral: Usual Care

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Institute of Neuroscience, Université catholique de Louvain
• France
  • Brest, France
    • Fondation ILDYS - Site de Ty Yann
• Italy
  • Toscana
    • Marina Di Pisa-Tirrenia-Calambrone, Toscana, Italy, 56128
      • IRCCS Fondazione Stella Maris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	pre-camp, two weeks post-camp, 3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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.	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).	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).	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).	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.	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)	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)	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.	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.	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	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).	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).	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).	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).	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).	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)	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)	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).	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)	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.	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.	5 hours during 5 consecutive days

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Collaborators: University of Pisa; University Hospital, Angers; University of the Balearic Islands; University Hospital, Brest; University of Lausanne Hospitals; Fondation Paralysie Cérébrale
• Investigators: Principal Investigator: Yannick Bleyenheuft, Pr, MSL-IN Lab, Institute of Neuroscience, Université catholique de Louvain

Publications and helpful links

General 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.

Helpful Links

• Lab website

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: motor skill learning; functional changes; neuroplastic changes; biomechanical changes
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: B403201316810d

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No