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

December 3, 2020 updated by: Yannick Bleyenheuft, Université Catholique de Louvain

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1150
        • Bleyenheuft Yannick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at baseline and after 90 hours/two weeks of intensive bimanual intervention
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
at baseline and after 90 hours/two weeks of intensive bimanual intervention
changes in line bissection
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
deviation from midline during line section
at baseline and after 90 hours/two weeks of intensive bimanual intervention
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
at baseline and after 90 hours/two weeks of intensive bimanual intervention
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
at baseline and after 90 hours/two weeks of intensive bimanual intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
at baseline and after 90 hours/two weeks of intensive bimanual intervention
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)
at baseline and after 90 hours/two weeks of intensive bimanual intervention
Box and blocks
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
number of blocks manipulated in one minute
at baseline and after 90 hours/two weeks of intensive bimanual intervention
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
at baseline and after 90 hours/two weeks of intensive bimanual intervention
"ABILHAND-Kids" questionnaire
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
parents-reported questionnaire measuring manual ability
at baseline and after 90 hours/two weeks of intensive bimanual intervention
"ACTIVLIM-CP" questionnaire
Time Frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
parents-reported questionnaire measuring global activity performance
at baseline and after 90 hours/two weeks of intensive bimanual intervention
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 (%)
at baseline and after 90 hours/two weeks of intensive bimanual intervention
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)
at baseline and after 90 hours/two weeks of intensive bimanual intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Catholique de Louvain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yannick Bleyenheuft, PhD, Institute of Neuroscience, Université catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B403201316810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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