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

NCT02946086 | Completed

• 1 other identifier: B403201316810
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

motor skill learning, visuo-spatial attention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Jebsen-Taylor test of hand function

  at baseline and after 90 hours/two weeks of intensive bimanual intervention

• functional magnetic resonance imaging (fMRI)

  at baseline and after 90 hours/two weeks of intensive bimanual intervention

• Box and blocks

  at baseline and after 90 hours/two weeks of intensive bimanual intervention

• Assisting Hand Assessment

  at baseline and after 90 hours/two weeks of intensive bimanual intervention

• "ABILHAND-Kids" questionnaire

  at baseline and after 90 hours/two weeks of intensive bimanual intervention

Study Arms (2)

prismatic adaptation

EXPERIMENTAL

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

sham goggles

ACTIVE COMPARATOR

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

Behavioral: HABIT-ILE without prismatic adaptation

Interventions

HABIT-ILE with prismatic adaptation BEHAVIORAL

Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation

prismatic adaptation

HABIT-ILE without prismatic adaptation BEHAVIORAL

Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation wearing sham goggles.

sham goggles

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• unilateral CP
• minimal ability to pick an light object from a table
• age 5-18

You may not qualify if:

• no active seizure
• no botox or orthopedic intervention in the 6 months preceding the study or during the study

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Bleyenheuft Yannick

Brussels, 1150, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yannick Bleyenheuft, PhD

  Institute of Neuroscience, Université catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: October 26, 2016
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)