Congenital HemiplegiaPhase 1/2NCT01700777
Bimanual Training in Children With Hemiplegia With Lower Limb and Postural Stimulation (HABIT & Leg)
A Phase 1/2 study testing "HABIT-ILE" in people with Congenital Hemiplegia, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
A randomized control trial of "HABIT-ILE" therapy compared with regular / conventional intervention (same amount of hours). The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Hemiplegia
- What is being tested?
- "HABIT-ILE"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2010to Jan 2014
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- willingness to enter the research program and the testing procedures
Who cannot join
- uncontrolled epilepsy
- upper limb injections in the upper limb during the last six months / or intend to receive during the training period
Trial locations and contacts
1 site in 1 country.
Corinne Bleyenheuft, MD resp. contact
Belgium1 site, 1 recruiting
- Recruiting
Institute of Neurosciences, UCL
Brussels, Brussels Capital, 1200
Yannick Bleyenheuft, PhD, +32486919911, yannick.bleyenheuft@gmail.com
Yannick Bleyenheuft, PhD
About this study
Official title: Effet de la réadaptation Sur Les déficiences, Limitations d'activité et Restriction de la Participation Des Enfants présentant Des lésions Neurologiques Non-évolutives (Infirmes Moteurs cérébraux).
A randomized control trial of "HABIT-ILE" therapy compared with regular / conventional intervention (same amount of hours). The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University.
Read the detailed description
A randomized control trial of "HABIT-ILE" therapy at intensive frequency contrasted with regular frequency intervention. The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University. The intervention takes place either in a 2 weeks day and night camp, either in regular/conventional intervention (1 to 5 hours a week). Children of all groups will benefit from 90h of intensive treatment (children in regular frequency will be crossed over afterwards to benefit from HABIT-ILE. Both in the camp and the regular interventions, there is at least one therapist for each child.
- Conditions
- Congenital Hemiplegia
- Being tested
- "HABIT-ILE"
- Keywords
- bimanual training, lower limb, intensive rehabilitation, regular rehabilitation, hemiplegia
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"HABIT-ILE"Other
Also called Bimanual training, HABIT, neurorehabilitation
90 h of training with "HABIT-ILE", in an intensive rehabilitation camp compared with a regular therapy program (groups are crossed-over afterwards).
| Study group | Role | What they receive |
|---|---|---|
| Intensive rehab group | Experimental | A group of children will beneficiate of "HABIT-ILE" treatment in an intensive way (camp) for 90h. Receives: Other: "HABIT-ILE" |
| Regular treatment group | Active comparator | A group of children with hemiplegic cerebral palsy will beneficiate from conventional training at a regular frequency (1 to 6 hours / week) for 90hours. Receives: Other: "HABIT-ILE" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairment, disability, participation
The 3 WHO main domains will be investigated. Impairments will be investigated through force, sensory and manipulation testing (including manipulation with mechanical device). Analysis of lower limb is also included in the protocol. Disabilities will be tested through video-taped assessments and questionnaires. Participation will be assessed through questionnaires.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startNov 2010
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital HemiplegiaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Collaborators
- Université Catholique de Louvain
- Responsible party
- Principal investigator, Yannick Bleyenheuft, University Hospital of Mont-Godinne
- Investigators
- Yannick Bleyenheuft, PhD, Principal investigator, Institute of Neurosciences, UCLCorinne Bleyenheuft, MD, Principal investigator, Cliniques Universitaires de Mont-Godinne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700777
- Sponsor's protocol ID
- UHMG-IONS-862010
- Status last verified
- Jan 2014
- First submitted
- 2 Oct 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Araneda R, Dricot L, Ebner-Karestinos D, Paradis J, Gordon AM, Friel KM, Bleyenheuft Y. Brain activation changes following motor training in children with unilateral cerebral palsy: An fMRI study. Ann Phys Rehabil Med. 2021 May;64(3):101502. doi: 10.1016/j.rehab.2021.101502. Epub 2021 Mar 22.
PubMed 33647530Bleyenheuft Y, Dricot L, Ebner-Karestinos D, Paradis J, Saussez G, Renders A, De Volder A, Araneda R, Gordon AM, Friel KM. Motor Skill Training May Restore Impaired Corticospinal Tract Fibers in Children With Cerebral Palsy. Neurorehabil Neural Repair. 2020 Jun;34(6):533-546. doi: 10.1177/1545968320918841. Epub 2020 May 14.
PubMed 32407247Bleyenheuft Y, Arnould C, Brandao MB, Bleyenheuft C, Gordon AM. Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. Neurorehabil Neural Repair. 2015 Aug;29(7):645-57. doi: 10.1177/1545968314562109. Epub 2014 Dec 19.
PubMed 25527487
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effet de la réadaptation Sur Les déficiences, Limitations d'activité et Restriction de la Participation Des Enfants présentant Des lésions Neurologiques Non-évolutives (Infirmes Moteurs cérébraux).
- ClinicalTrials.gov ID
- NCT01700777
- Acronym / sponsor ID
- UHMG-IONS-862010
- Conditions
- Congenital Hemiplegia
- Keywords
- bimanual training, lower limb, intensive rehabilitation, regular rehabilitation, hemiplegia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Collaborators
- Université Catholique de Louvain
- Study start
- Nov 2010
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 4 Oct 2012 (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.
A randomized control trial of "HABIT-ILE" therapy compared with regular / conventional intervention (same amount of hours). The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University.
Detailed description
A randomized control trial of "HABIT-ILE" therapy at intensive frequency contrasted with regular frequency intervention. The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University. The intervention takes place either in a 2 weeks day and night camp, either in regular/conventional intervention (1 to 5 hours a week). Children of all groups will benefit from 90h of intensive treatment (children in regular frequency will be crossed over afterwards to benefit from HABIT-ILE. Both in the camp and the regular interventions, there is at least one therapist for each child.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive rehab group | Experimental | Other: "HABIT-ILE"A group of children will beneficiate of "HABIT-ILE" treatment in an intensive way (camp) for 90h. |
| Regular treatment group | Active comparator | Other: "HABIT-ILE"A group of children with hemiplegic cerebral palsy will beneficiate from conventional training at a regular frequency (1 to 6 hours / week) for 90hours. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- willingness to enter the research program and the testing procedures
Key exclusion criteria (2 listed)
- uncontrolled epilepsy
- upper limb injections in the upper limb during the last six months / or intend to receive during the training period
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"Also: Bimanual training, HABIT, neurorehabilitation90 h of training with "HABIT-ILE", in an intensive rehabilitation camp compared with a regular therapy program (groups are crossed-over afterwards). | Other | Intensive rehab group, Regular treatment group |
Primary outcome
Impairment, disability, participation
Time frame: 4 years
The 3 WHO main domains will be investigated. Impairments will be investigated through force, sensory and manipulation testing (including manipulation with mechanical device). Analysis of lower limb is also included in the protocol. Disabilities will be tested through video-taped assessments and questionnaires. Participation will be assessed through questionnaires.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Derived from this study: PubMed 33647530Araneda R, Dricot L, Ebner-Karestinos D, Paradis J, Gordon AM, Friel KM, Bleyenheuft Y. Brain activation changes following motor training in children with unilateral cerebral palsy: An fMRI study. Ann Phys Rehabil Med. 2021 May;64(3):101502. doi: 10.1016/j.rehab.2021.101502. Epub 2021 Mar 22.
- Derived from this study: PubMed 32407247Bleyenheuft Y, Dricot L, Ebner-Karestinos D, Paradis J, Saussez G, Renders A, De Volder A, Araneda R, Gordon AM, Friel KM. Motor Skill Training May Restore Impaired Corticospinal Tract Fibers in Children With Cerebral Palsy. Neurorehabil Neural Repair. 2020 Jun;34(6):533-546. doi: 10.1177/1545968320918841. Epub 2020 May 14.
- Derived from this study: PubMed 25527487Bleyenheuft Y, Arnould C, Brandao MB, Bleyenheuft C, Gordon AM. Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. Neurorehabil Neural Repair. 2015 Aug;29(7):645-57. doi: 10.1177/1545968314562109. Epub 2014 Dec 19.
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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.
Corinne Bleyenheuft, MD resp. contact
Yannick Bleyenheuft, PhD principal investigator
Institute of Neurosciences, UCL
Corinne Bleyenheuft, MD principal investigator
Cliniques Universitaires de Mont-Godinne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing "HABIT-ILE" in people with Congenital Hemiplegia, run by University Hospital of Mont-Godinne 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 1 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: status not confirmed, as of the sponsor's last update on 22 Jan 2014. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick Bleyenheuft, PhD (+32486919911, yannick.bleyenheuft@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impairment, disability, participation (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01700777, which also lists 3 linked publications.
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 22 Jan 2014.