Effect of HABIT-ILE on the Body Function and Structures of Children With Cerebral Palsy

Study Overview
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Brief Summary
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There is strong evidence that recent intensive interventions based on motor skill learning principles are efficient on functional and neuroplastic changes of children with cerebral palsy (CP). Besides, impaired selective voluntary motor control (SVMC) is one of four interrelated neuromuscular deficits in children with CP and is listed in the ICF-CY (International Classification of Functioning, Disability and Health for Children and Youth) under body functions. Additionally, impaired SVMC has been shown to negatively affect the motor and functional abilities of children with CP. However, there have been little scientific investigations on the trainability of SVMC according to therapeutic interventions. Therefore, the study aims to evaluate the effect of Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on the body function and structures of children with bilateral and unilateral cerebral palsy, including SVMC and brain structure.

Official Title
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Effect of Hand and Arm Bimanual Intensive Therapy Including Lower Extremities on the Body Function and Structures of Children With Bilateral and Unilateral Cerebral Palsy, Including Selective Voluntary Motor Control and Brain Structure

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Behavioral: HABIT-ILE
* Behavioral: Conventional intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed bilateral and unilateral cerebral palsy, MACS levels from I to IV, GMFCS levels from I to IV, Ability to follow instructions and complete testing. Exclusion Criteria: Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period. Unstable seizure Severe visual or cognitive impairments likely to interfere with intervention or testing session completion

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HABIT-ILE<br>Hand and arm bimanual intensive therapy including lower extremities | Behavioral: HABIT-ILE<br>* 2 weeks HABIT-ILE<br>|
| Active Comparator: Conventional intervention<br>Conventional physical and occupational therapy | Behavioral: Conventional intervention<br>* 2 weeks usual intervention (waitlist group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 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 (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Test of Arm Selective Control (TASC) | 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. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Selective Control Assessment of the Lower Extremity (SCALE): | 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). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Strength | The strength will be measured for main muscle groups using a Microfet. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Stiffness | The stiffness will be measured using a device developed and already validated at UCLouvain. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Assisting Hand Assessment (AHA or BoHA) | 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. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in ABILHAND-Kids Questionnaire | 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). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in ACTIVLIM-CP Questionnaire | 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). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Gross Motor Function Measurement (GMFM 66) | The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in 6 Minutes Walking Test (6MWT) | 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. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Box and Blocks test | 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. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Jebsen-Taylor Test | 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. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Modified Cooper test | 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. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in ABILOCO-Kids Questionnaire | 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). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) | 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). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Canadian Occupational Performance Measure (COPM) | 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. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Double Inversion Recovery (DIR) | This sequence allows to identify an inflamatory lesion. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Functional resting state (RS) | This sequence allows to evaluate the regional interactions that occur in a resting or task-negative state. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in T1-weighted and T2-weighted structural imaging | The difference between these sequences allows to evaluated changes in the cortical myelin. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in Executive Functions | Cognitive functions of the children will be assessed by Stroop task and Flanker task. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in 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 (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in temporal parameters of the gait (Cycle time) | Through a 3D motion system, we measure the cycle of gait time (seconds). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in temporal parameters of the gait (Stance time) | Through a 3D motion system, we measure the stance time (percentage of the total gait cycle). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in temporal parameters of the gait (Swing time) | Through a 3D motion system, we measure the swing time (percentage of the total gait cycle). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in temporal parameters of the gait (Stride) | Through a 3D motion system, we measure the gait cadence (stride per minute). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in temporal parameters of the gait (Velocity) | Through a 3D motion system, we measure the gait velocity (meter/second). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in temporal parameters of the gait (Acceleration) | Through a 3D motion system, we measure the gait acceleration (meters/second^2) | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in 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 (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in 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 (1 week before), post-camp (1 week after), 3 months follow-up | 
| Changes in 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 consists in a bimanual reaching task. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor skill learning, body function, body structure, selective voluntary motor control, brain structure, neuroplasticity, intensive therapy, cerebral palsy