Clinical trial NCT04403490: Effect of HABIT-ILE on the Body Function and Structures of Children With Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: motor skill learning
body function
body structure
selective voluntary motor control
brain structure
neuroplasticity
intensive therapy
cerebral palsy
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Diffusion Tensor Imaging (DTI)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Test of Arm Selective Control (TASC)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Selective Control Assessment of the Lower Extremity (SCALE):
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Strength
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Stiffness
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Secondary outcomes:
measure: Changes in Assisting Hand Assessment (AHA or BoHA)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in ABILHAND-Kids Questionnaire
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in ACTIVLIM-CP Questionnaire
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Gross Motor Function Measurement (GMFM 66)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in 6 Minutes Walking Test (6MWT)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Box and Blocks test
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Jebsen-Taylor Test
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Modified Cooper test
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in ABILOCO-Kids Questionnaire
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Canadian Occupational Performance Measure (COPM)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Double Inversion Recovery (DIR)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Functional resting state (RS)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in T1-weighted and T2-weighted structural imaging
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in Executive Functions
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in spatial parameters of the gait (Kinematics assessments)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Cycle time)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Stance time)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Swing time)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Stride)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Velocity)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the gait (Acceleration)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in spatial parameters of the upper extremity (Straightness)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in spatial parameters of the upper extremity (Smoothness)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
measure: Changes in temporal parameters of the upper extremity (Kinematics assessments)
timeFrame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institute of Neuroscience, UCLouvain
Study officials:
affiliation: Institute of Neuroscience, UCLouvain
name: Yannick Bleyenheuft
role: PRINCIPAL_INVESTIGATOR
References: