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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04403490
• Other study ID #: B403201316810f
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: June 2022
• Source: Université Catholique de Louvain
• Contact: Yannick Bleyenheuft, Professor
• Phone: +32 2 764 93 49
• Email: yannick.bleyenheuft[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 20, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Behavioral:
• HABIT-ILE
2 weeks HABIT-ILE
• Conventional intervention
2 weeks usual intervention (waitlist group)

Locations

Country	Name	City	State
Belgium	Institute of Neuroscience, UCLouvain	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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