Effect of HABIT-ILE on the Body Function and Structures of Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HABIT-ILE
Conventional intervention
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring motor skill learning, body function, body structure, selective voluntary motor control, brain structure, neuroplasticity, intensive therapy, cerebral palsy
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
Sites / Locations
- Institute of Neuroscience, UCLouvainRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HABIT-ILE
Conventional intervention
Arm Description
Hand and arm bimanual intensive therapy including lower extremities
Conventional physical and occupational therapy
Outcomes
Primary Outcome Measures
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.
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.
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).
Changes in Strength
The strength will be measured for main muscle groups using a Microfet.
Changes in Stiffness
The stiffness will be measured using a device developed and already validated at UCLouvain.
Secondary Outcome Measures
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.
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).
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).
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.
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.
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.
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.
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.
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).
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).
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.
Changes in Double Inversion Recovery (DIR)
This sequence allows to identify an inflamatory lesion.
Changes in Functional resting state (RS)
This sequence allows to evaluate the regional interactions that occur in a resting or task-negative state.
Changes in T1-weighted and T2-weighted structural imaging
The difference between these sequences allows to evaluated changes in the cortical myelin.
Changes in Executive Functions
Cognitive functions of the children will be assessed by Stroop task and Flanker task.
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).
Changes in temporal parameters of the gait (Cycle time)
Through a 3D motion system, we measure the cycle of gait time (seconds).
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).
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).
Changes in temporal parameters of the gait (Stride)
Through a 3D motion system, we measure the gait cadence (stride per minute).
Changes in temporal parameters of the gait (Velocity)
Through a 3D motion system, we measure the gait velocity (meter/second).
Changes in temporal parameters of the gait (Acceleration)
Through a 3D motion system, we measure the gait acceleration (meters/second^2)
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).
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)
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.
Full Information
NCT ID
NCT04403490
First Posted
May 20, 2020
Last Updated
June 14, 2022
Sponsor
Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT04403490
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
motor skill learning, body function, body structure, selective voluntary motor control, brain structure, neuroplasticity, intensive therapy, cerebral palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HABIT-ILE
Arm Type
Experimental
Arm Description
Hand and arm bimanual intensive therapy including lower extremities
Arm Title
Conventional intervention
Arm Type
Active Comparator
Arm Description
Conventional physical and occupational therapy
Intervention Type
Behavioral
Intervention Name(s)
HABIT-ILE
Intervention Description
2 weeks HABIT-ILE
Intervention Type
Behavioral
Intervention Name(s)
Conventional intervention
Intervention Description
2 weeks usual intervention (waitlist group)
Primary Outcome Measure Information:
Title
Changes in Diffusion Tensor Imaging (DTI)
Description
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.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Test of Arm Selective Control (TASC)
Description
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.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Selective Control Assessment of the Lower Extremity (SCALE):
Description
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).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Strength
Description
The strength will be measured for main muscle groups using a Microfet.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Stiffness
Description
The stiffness will be measured using a device developed and already validated at UCLouvain.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Secondary Outcome Measure Information:
Title
Changes in Assisting Hand Assessment (AHA or BoHA)
Description
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.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in ABILHAND-Kids Questionnaire
Description
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).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in ACTIVLIM-CP Questionnaire
Description
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).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Gross Motor Function Measurement (GMFM 66)
Description
The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in 6 Minutes Walking Test (6MWT)
Description
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.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Box and Blocks test
Description
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.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Jebsen-Taylor Test
Description
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.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Modified Cooper test
Description
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.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in ABILOCO-Kids Questionnaire
Description
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).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
Description
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).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Double Inversion Recovery (DIR)
Description
This sequence allows to identify an inflamatory lesion.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Functional resting state (RS)
Description
This sequence allows to evaluate the regional interactions that occur in a resting or task-negative state.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in T1-weighted and T2-weighted structural imaging
Description
The difference between these sequences allows to evaluated changes in the cortical myelin.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in Executive Functions
Description
Cognitive functions of the children will be assessed by Stroop task and Flanker task.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in spatial parameters of the gait (Kinematics assessments)
Description
Through a 3D motion system, we measure the stride length (meters), step length (meters) and step width (meters).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in temporal parameters of the gait (Cycle time)
Description
Through a 3D motion system, we measure the cycle of gait time (seconds).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in temporal parameters of the gait (Stance time)
Description
Through a 3D motion system, we measure the stance time (percentage of the total gait cycle).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in temporal parameters of the gait (Swing time)
Description
Through a 3D motion system, we measure the swing time (percentage of the total gait cycle).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in temporal parameters of the gait (Stride)
Description
Through a 3D motion system, we measure the gait cadence (stride per minute).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in temporal parameters of the gait (Velocity)
Description
Through a 3D motion system, we measure the gait velocity (meter/second).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in temporal parameters of the gait (Acceleration)
Description
Through a 3D motion system, we measure the gait acceleration (meters/second^2)
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in spatial parameters of the upper extremity (Straightness)
Description
Through a 3D motion system, we measure the straightness (percentage of upper extremity trajectory during a reaching task).
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in spatial parameters of the upper extremity (Smoothness)
Description
Through a 3D motion system, we measure the smoothness (variability of the movement during a reaching task)
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Title
Changes in temporal parameters of the upper extremity (Kinematics assessments)
Description
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.
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yannick Bleyenheuft, Professor
Phone
+32 2 764 93 49
Email
yannick.bleyenheuft@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Seyma Kilcioglu, PhD Student
Email
seyma.kilcioglu@student.uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannick Bleyenheuft
Organizational Affiliation
Institute of Neuroscience, UCLouvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neuroscience, UCLouvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick Bleyenheuft, Pr
Email
yannick.bleyenheuft@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Seyma Kilcioglu, PhD Student
Email
seyma.kilcioglu@student.uclouvain.be
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of HABIT-ILE on the Body Function and Structures of Children With Cerebral Palsy
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