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

Cerebral Palsy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946086
• Other study ID #: B403201316810
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2020
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• HABIT-ILE with prismatic adaptation
Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation
• HABIT-ILE without prismatic adaptation
Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation wearing sham goggles.

Locations

Country	Name	City	State
Belgium	Bleyenheuft Yannick	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	changes in line bissection	deviation from midline during line section	at baseline and after 90 hours/two weeks of intensive bimanual intervention
Primary	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
Primary	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	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
Secondary	functional magnetic resonance imaging (fMRI)	cortical activation (changes in voxels activation)	at baseline and after 90 hours/two weeks of intensive bimanual intervention
Secondary	Box and blocks	number of blocks manipulated in one minute	at baseline and after 90 hours/two weeks of intensive bimanual intervention
Secondary	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
Secondary	"ABILHAND-Kids" questionnaire	parents-reported questionnaire measuring manual ability	at baseline and after 90 hours/two weeks of intensive bimanual intervention
Secondary	"ACTIVLIM-CP" questionnaire	parents-reported questionnaire measuring global activity performance	at baseline and after 90 hours/two weeks of intensive bimanual intervention
Secondary	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
Secondary	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

External Links

•   lab's web page