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

NCT ID: NCT04403490

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-26

Study Completion Date

2022-12-20

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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HABIT-ILE

Hand and arm bimanual intensive therapy including lower extremities

Group Type EXPERIMENTAL

HABIT-ILE

Intervention Type BEHAVIORAL

2 weeks HABIT-ILE

Conventional intervention

Conventional physical and occupational therapy

Group Type ACTIVE_COMPARATOR

Conventional intervention

Intervention Type BEHAVIORAL

2 weeks usual intervention (waitlist group)

Interventions

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HABIT-ILE

2 weeks HABIT-ILE

Intervention Type BEHAVIORAL

Conventional intervention

2 weeks usual intervention (waitlist group)

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Yannick Bleyenheuft

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yannick Bleyenheuft

Role: PRINCIPAL_INVESTIGATOR

Institute of Neuroscience, UCLouvain

Locations

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Institute of Neuroscience, UCLouvain

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Yannick Bleyenheuft, Professor

Role: CONTACT

+32 2 764 93 49

Seyma Kilcioglu, PhD Student

Role: CONTACT

Facility Contacts

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Yannick Bleyenheuft, Pr

Role: primary

Seyma Kilcioglu, PhD Student

Role: backup

Other Identifiers

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B403201316810f

Identifier Type: -

Identifier Source: org_study_id

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