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Completed

NCT Number: NCT02946086

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bleyenheuft Yannick

Brussels, 1150, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HABIT-ILE with prismatic adaptation

Behavioral

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

HABIT-ILE without prismatic adaptation

Behavioral

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

Primary outcomes

  1. changes in star cancellation

    Time frame: 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

  2. change in "Ogden Figure" test

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

    number of elements omitted when reproducing a drawing

  3. changes in line bissection

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

    deviation from midline during line section

  4. visuo-spatial pointing

    Time frame: 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

  5. proprioceptive pointing

    Time frame: 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 outcomes

  1. Jebsen-Taylor test of hand function

    Time frame: 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

  2. functional magnetic resonance imaging (fMRI)

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

    cortical activation (changes in voxels activation)

  3. Box and blocks

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

    number of blocks manipulated in one minute

  4. Assisting Hand Assessment

    Time frame: 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

  5. "ABILHAND-Kids" questionnaire

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

    parents-reported questionnaire measuring manual ability

  6. "ACTIVLIM-CP" questionnaire

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

    parents-reported questionnaire measuring global activity performance

  7. Canadian Occupationnal Performance Measure

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

    setting therapeutic goals with parents and measuring both performance and satisfaction (%)

  8. diffusion tensor imaging (DDTI)

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

    measuring changes in white matter tracts (fractional anisotropy, number of voxels)

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study 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

Acronym: HABIT-ILE_CP

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 26, 2016
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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