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Effect of HABIT-ILE on Visuo-spatial Attention of Children With Unilateral CP (HABIT-ILE_CP)

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HABIT-ILE with prismatic adaptation
HABIT-ILE without prismatic adaptation
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring motor skill learning, visuo-spatial attention

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bleyenheuft Yannick

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

prismatic adaptation

sham goggles

Arm Description

Including 8 hours of therapy with prismatic adaptation wearing prismatic goggles during bimanual intensive and locomotor intensive intervention (HABIT-ILE).

Including 8 hours of therapy wearing "sham goggles" during bimanual intensive and locomotor intensive intervention (HABIT-ILE).

Outcomes

Primary Outcome Measures

changes in star cancellation
number of little stars omitted in a frame including many stars of different size
change in "Ogden Figure" test
number of elements omitted when reproducing a drawing
changes in line bissection
deviation from midline during line section
visuo-spatial pointing
pointing in a blind box in the direction of a visual cue, measuring the deviation from midline
proprioceptive pointing
pointing without any visual feedback in the direction of body midline and measuring deviation

Secondary Outcome Measures

Jebsen-Taylor test of hand function
Manual dexterity measured with objects of everyday life, measure=time to manipulate objects
functional magnetic resonance imaging (fMRI)
cortical activation (changes in voxels activation)
Box and blocks
number of blocks manipulated in one minute
Assisting Hand Assessment
help provided by the paretic hand to the non-paretic one in bimanual coordination
"ABILHAND-Kids" questionnaire
parents-reported questionnaire measuring manual ability
"ACTIVLIM-CP" questionnaire
parents-reported questionnaire measuring global activity performance
Canadian Occupationnal Performance Measure
setting therapeutic goals with parents and measuring both performance and satisfaction (%)
diffusion tensor imaging (DDTI)
measuring changes in white matter tracts (fractional anisotropy, number of voxels)

Full Information

First Posted
December 21, 2015
Last Updated
December 3, 2020
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT02946086
Brief Title
Effect of HABIT-ILE on Visuo-spatial Attention of Children With Unilateral CP
Acronym
HABIT-ILE_CP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

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, visuo-spatial attention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prismatic adaptation
Arm Type
Experimental
Arm Description
Including 8 hours of therapy with prismatic adaptation wearing prismatic goggles during bimanual intensive and locomotor intensive intervention (HABIT-ILE).
Arm Title
sham goggles
Arm Type
Active Comparator
Arm Description
Including 8 hours of therapy wearing "sham goggles" during bimanual intensive and locomotor intensive intervention (HABIT-ILE).
Intervention Type
Behavioral
Intervention Name(s)
HABIT-ILE with prismatic adaptation
Intervention Description
Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation
Intervention Type
Behavioral
Intervention Name(s)
HABIT-ILE without prismatic adaptation
Intervention Description
Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation wearing sham goggles.
Primary Outcome Measure Information:
Title
changes in star cancellation
Description
number of little stars omitted in a frame including many stars of different size
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
change in "Ogden Figure" test
Description
number of elements omitted when reproducing a drawing
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
changes in line bissection
Description
deviation from midline during line section
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
visuo-spatial pointing
Description
pointing in a blind box in the direction of a visual cue, measuring the deviation from midline
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
proprioceptive pointing
Description
pointing without any visual feedback in the direction of body midline and measuring deviation
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Secondary Outcome Measure Information:
Title
Jebsen-Taylor test of hand function
Description
Manual dexterity measured with objects of everyday life, measure=time to manipulate objects
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
functional magnetic resonance imaging (fMRI)
Description
cortical activation (changes in voxels activation)
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
Box and blocks
Description
number of blocks manipulated in one minute
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
Assisting Hand Assessment
Description
help provided by the paretic hand to the non-paretic one in bimanual coordination
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
"ABILHAND-Kids" questionnaire
Description
parents-reported questionnaire measuring manual ability
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
"ACTIVLIM-CP" questionnaire
Description
parents-reported questionnaire measuring global activity performance
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
Canadian Occupationnal Performance Measure
Description
setting therapeutic goals with parents and measuring both performance and satisfaction (%)
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Title
diffusion tensor imaging (DDTI)
Description
measuring changes in white matter tracts (fractional anisotropy, number of voxels)
Time Frame
at baseline and after 90 hours/two weeks of intensive bimanual intervention

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannick Bleyenheuft, PhD
Organizational Affiliation
Institute of Neuroscience, Université catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bleyenheuft Yannick
City
Brussels
ZIP/Postal Code
1150
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://uclouvain.be/en/research-institutes/ions/cosy/motor-skill-learning-and-intensive-neurorehabilitation-lab-msl-in.html
Description
lab's web page

Learn more about this trial

Effect of HABIT-ILE on Visuo-spatial Attention of Children With Unilateral CP

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