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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Behavioral: HABIT-ILE without prismatic adaptation; Behavioral: HABIT-ILE with prismatic adaptation

• Registration Number: NCT02946086
• Lead Sponsor: Université Catholique de Louvain

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham goggles	HABIT-ILE without prismatic adaptation	Including 8 hours of therapy wearing "sham goggles" during bimanual intensive and locomotor intensive intervention (HABIT-ILE).
prismatic adaptation	HABIT-ILE with prismatic adaptation	Including 8 hours of therapy with prismatic adaptation wearing prismatic goggles during bimanual intensive and locomotor intensive intervention (HABIT-ILE).

Primary Outcome Measures

Name	Time	Method
change in "Ogden Figure" test	at baseline and after 90 hours/two weeks of intensive bimanual intervention	number of elements omitted when reproducing a drawing
visuo-spatial pointing	at baseline and after 90 hours/two weeks of intensive bimanual intervention	pointing in a blind box in the direction of a visual cue, measuring the deviation from midline
changes in star cancellation	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
changes in line bissection	at baseline and after 90 hours/two weeks of intensive bimanual intervention	deviation from midline during line section
proprioceptive pointing	at baseline and after 90 hours/two weeks of intensive bimanual intervention	pointing without any visual feedback in the direction of body midline and measuring deviation

Secondary Outcome Measures

Name	Time	Method
Jebsen-Taylor test of hand function	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
functional magnetic resonance imaging (fMRI)	at baseline and after 90 hours/two weeks of intensive bimanual intervention	cortical activation (changes in voxels activation)
Assisting Hand Assessment	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
"ABILHAND-Kids" questionnaire	at baseline and after 90 hours/two weeks of intensive bimanual intervention	parents-reported questionnaire measuring manual ability
diffusion tensor imaging (DDTI)	at baseline and after 90 hours/two weeks of intensive bimanual intervention	measuring changes in white matter tracts (fractional anisotropy, number of voxels)
Box and blocks	at baseline and after 90 hours/two weeks of intensive bimanual intervention	number of blocks manipulated in one minute
"ACTIVLIM-CP" questionnaire	at baseline and after 90 hours/two weeks of intensive bimanual intervention	parents-reported questionnaire measuring global activity performance
Canadian Occupationnal Performance Measure	at baseline and after 90 hours/two weeks of intensive bimanual intervention	setting therapeutic goals with parents and measuring both performance and satisfaction (%)

Trial Locations

Locations (1)

Bleyenheuft Yannick; 🇧🇪 Brussels, Belgium