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

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: Cerebral Palsy
• Intervention / Treatment: Behavioral: HABIT-ILE with prismatic adaptation; Behavioral: HABIT-ILE without prismatic adaptation

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

Study Locations

• Belgium
  • Brussels, Belgium, 1150
    • Bleyenheuft Yannick

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prismatic adaptation; Including 8 hours of therapy with prismatic adaptation wearing prismatic goggles during bimanual intensive and locomotor intensive intervention (HABIT-ILE).	Behavioral: HABIT-ILE with prismatic adaptation; Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation
Active Comparator: sham goggles; Including 8 hours of therapy wearing "sham goggles" during bimanual intensive and locomotor intensive intervention (HABIT-ILE).	Behavioral: HABIT-ILE without prismatic adaptation; Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation wearing sham goggles.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: Yannick Bleyenheuft, PhD, Institute of Neuroscience, Université catholique de Louvain

Publications and helpful links

Helpful Links

• lab's web page

Study record dates

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

• Keywords: motor skill learning, visuo-spatial attention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: B403201316810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO