Effect of HABIT-ILE on Visuo-spatial Attention of Children With Unilateral CP (HABIT-ILE_CP)
December 3, 2020 updated by: Yannick Bleyenheuft, Université Catholique de Louvain
Effect of Rehabilitation in Deficiencies, Activities Limitations and Restrictions of the Participation of the Children Presenting Neurological Lesions. Impact of Contextual Factors on the Functioning of These Patients. Part II
This study aims to investigate the changes induced by HABIT-ILE in impairments, activity and participation of children with unilateral CP, as well as neuroplastic changes induced by the treatment.
Visuospatial deficits will be investigated and the effect of prismatic adaptation will be measured.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aims to investigate the changes induced by HABIT-ILE at the 3 levels of the international classification of functioning and health (ICF) in children with unilateral CP, as well as neuroplastic changes induced by the treatment.
Visuospatial deficits will be investigated and the effect of prismatic adaptation will be measured.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brussels, Belgium, 1150
- Bleyenheuft Yannick
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- unilateral CP
- minimal ability to pick an light object from a table
- age 5-18
Exclusion Criteria:
- no active seizure
- no botox or orthopedic intervention in the 6 months preceding the study or during the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: prismatic adaptation
Including 8 hours of therapy with prismatic adaptation wearing prismatic goggles during bimanual intensive and locomotor intensive intervention (HABIT-ILE).
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Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation
|
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Active Comparator: sham goggles
Including 8 hours of therapy wearing "sham goggles" during bimanual intensive and locomotor intensive intervention (HABIT-ILE).
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Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation wearing sham goggles.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in star cancellation
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
number of little stars omitted in a frame including many stars of different size
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
|
change in "Ogden Figure" test
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
number of elements omitted when reproducing a drawing
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
|
changes in line bissection
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
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deviation from midline during line section
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
|
visuo-spatial pointing
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
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pointing in a blind box in the direction of a visual cue, measuring the deviation from midline
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
|
proprioceptive pointing
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
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pointing without any visual feedback in the direction of body midline and measuring deviation
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jebsen-Taylor test of hand function
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
Manual dexterity measured with objects of everyday life, measure=time to manipulate objects
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
|
functional magnetic resonance imaging (fMRI)
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
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cortical activation (changes in voxels activation)
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
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Box and blocks
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
number of blocks manipulated in one minute
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
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Assisting Hand Assessment
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
help provided by the paretic hand to the non-paretic one in bimanual coordination
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
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"ABILHAND-Kids" questionnaire
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
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parents-reported questionnaire measuring manual ability
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
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"ACTIVLIM-CP" questionnaire
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
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parents-reported questionnaire measuring global activity performance
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
|
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Canadian Occupationnal Performance Measure
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
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setting therapeutic goals with parents and measuring both performance and satisfaction (%)
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at baseline and after 90 hours/two weeks of intensive bimanual intervention
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diffusion tensor imaging (DDTI)
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
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measuring changes in white matter tracts (fractional anisotropy, number of voxels)
|
at baseline and after 90 hours/two weeks of intensive bimanual intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yannick Bleyenheuft, PhD, Institute of Neuroscience, Université catholique de Louvain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
December 21, 2015
First Submitted That Met QC Criteria
October 24, 2016
First Posted (Estimate)
October 26, 2016
Study Record Updates
Last Update Posted (Actual)
December 7, 2020
Last Update Submitted That Met QC Criteria
December 3, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B403201316810
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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