Cerebral PalsyHABIT-ILE_CPNCT02946086
Effect of HABIT-ILE on Visuo-spatial Attention of Children With Unilateral CP
A study testing HABIT-ILE with prismatic adaptation and HABIT-ILE without prismatic adaptation in people with Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- HABIT-ILE with prismatic adaptation and HABIT-ILE without prismatic adaptation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- unilateral CP
- minimal ability to pick an light object from a table
- age 5-18
Who cannot join
- no active seizure
- no botox or orthopedic intervention in the 6 months preceding the study or during the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- HABIT-ILE with prismatic adaptation, HABIT-ILE without prismatic adaptation
- Keywords
- motor skill learning, visuo-spatial attention
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HABIT-ILE with prismatic adaptationBehavioural
Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation
HABIT-ILE without prismatic adaptationBehavioural
Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation wearing sham goggles.
| Study group | Role | What they receive |
|---|---|---|
| prismatic adaptation | Experimental | Including 8 hours of therapy with prismatic adaptation wearing prismatic goggles during bimanual intensive and locomotor intensive intervention (HABIT-ILE). Receives: 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). Receives: Behavioral: HABIT-ILE without prismatic adaptation |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in star cancellation
number of little stars omitted in a frame including many stars of different size
Measured: 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
Measured: at baseline and after 90 hours/two weeks of intensive bimanual intervention
changes in line bissection
deviation from midline during line section
Measured: 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
Measured: 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
Measured: at baseline and after 90 hours/two weeks of intensive bimanual intervention
Secondary outcomes (8)
Jebsen-Taylor test of hand function
Manual dexterity measured with objects of everyday life, measure=time to manipulate objects
Measured: at baseline and after 90 hours/two weeks of intensive bimanual intervention
functional magnetic resonance imaging (fMRI)
cortical activation (changes in voxels activation)
Measured: at baseline and after 90 hours/two weeks of intensive bimanual intervention
Box and blocks
number of blocks manipulated in one minute
Measured: 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
Measured: at baseline and after 90 hours/two weeks of intensive bimanual intervention
"ABILHAND-Kids" questionnaire
parents-reported questionnaire measuring manual ability
Measured: at baseline and after 90 hours/two weeks of intensive bimanual intervention
"ACTIVLIM-CP" questionnaire
parents-reported questionnaire measuring global activity performance
Measured: 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 (%)
Measured: 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)
Measured: at baseline and after 90 hours/two weeks of intensive bimanual intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannick Bleyenheuft, Université Catholique de Louvain
- Investigators
- Yannick Bleyenheuft, PhD, Principal investigator, Institute of Neuroscience, Université catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946086
- Sponsor's protocol ID
- B403201316810
- Acronym
- HABIT-ILE_CP
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2015
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02946086
- Acronym / sponsor ID
- HABIT-ILE_CP / B403201316810
- Conditions
- Cerebral Palsy
- Keywords
- motor skill learning, visuo-spatial attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prismatic adaptation | Experimental | Behavioral: HABIT-ILE with prismatic adaptationIncluding 8 hours of therapy with prismatic adaptation wearing prismatic goggles during bimanual intensive and locomotor intensive intervention (HABIT-ILE). |
| sham goggles | Active comparator | Behavioral: HABIT-ILE without prismatic adaptationIncluding 8 hours of therapy wearing "sham goggles" during bimanual intensive and locomotor intensive intervention (HABIT-ILE). |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- unilateral CP
- minimal ability to pick an light object from a table
- age 5-18
Key exclusion criteria (2 listed)
- no active seizure
- no botox or orthopedic intervention in the 6 months preceding the study or during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HABIT-ILE with prismatic adaptationBimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation | Behavioural | prismatic adaptation |
| HABIT-ILE without prismatic adaptationBimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation wearing sham goggles. | Behavioural | sham goggles |
Primary outcome
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
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
changes in line bissection
Time frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention
deviation from midline during line section
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
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
8 secondary outcomes
Jebsen-Taylor test of hand function
Time frame: 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
Box and blocks
Time frame: 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
"ABILHAND-Kids" questionnaire
Time frame: 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
Canadian Occupationnal Performance Measure
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick Bleyenheuft, PhD principal investigator
Institute of Neuroscience, Université catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HABIT-ILE with prismatic adaptation and HABIT-ILE without prismatic adaptation in people with Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in star cancellation (time frame: at baseline and after 90 hours/two weeks of intensive bimanual intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.