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

NCT04403490 | Unknown

• 1 other identifier: B403201316810f
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

motor skill learning; body function; body structure; selective voluntary motor control; brain structure; neuroplasticity; intensive therapy; cerebral palsy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (25)

• Changes in Assisting Hand Assessment (AHA or BoHA)

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

• Changes in ABILHAND-Kids Questionnaire

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

• Changes in ACTIVLIM-CP Questionnaire

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

• Changes in Gross Motor Function Measurement (GMFM 66)

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

• Changes in 6 Minutes Walking Test (6MWT)

  pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

Study Arms (2)

HABIT-ILE

EXPERIMENTAL

Hand and arm bimanual intensive therapy including lower extremities

Behavioral: HABIT-ILE

Conventional intervention

ACTIVE COMPARATOR

Conventional physical and occupational therapy

Behavioral: Conventional intervention

Interventions

HABIT-ILE BEHAVIORAL

2 weeks HABIT-ILE

HABIT-ILE

Conventional intervention BEHAVIORAL

2 weeks usual intervention (waitlist group)

Conventional intervention

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Institute of Neuroscience, UCLouvain

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yannick Bleyenheuft

  Institute of Neuroscience, UCLouvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick Bleyenheuft, Professor

CONTACT

+32 2 764 93 49; yannick.bleyenheuft@uclouvain.be

Seyma Kilcioglu, PhD Student

CONTACT

seyma.kilcioglu@student.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 27, 2020
• Study Start: May 26, 2020
• Primary Completion: November 20, 2022
• Study Completion: December 20, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)