Bimanual Training in Children With Hemiplegia With Lower Limb and Postural Stimulation (HABIT & Leg)

NCT ID: NCT01700777

Last Updated: 2014-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-01-31

Brief Summary

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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

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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

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Congenital Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intensive rehab group

A group of children will beneficiate of "HABIT-ILE" treatment in an intensive way (camp) for 90h.

Group Type EXPERIMENTAL

"HABIT-ILE"

Intervention Type OTHER

90 h of training with "HABIT-ILE", in an intensive rehabilitation camp compared with a regular therapy program (groups are crossed-over afterwards).

Regular treatment group

A group of children with hemiplegic cerebral palsy will beneficiate from conventional training at a regular frequency (1 to 6 hours / week) for 90hours.

Group Type ACTIVE_COMPARATOR

"HABIT-ILE"

Intervention Type OTHER

90 h of training with "HABIT-ILE", in an intensive rehabilitation camp compared with a regular therapy program (groups are crossed-over afterwards).

Interventions

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"HABIT-ILE"

90 h of training with "HABIT-ILE", in an intensive rehabilitation camp compared with a regular therapy program (groups are crossed-over afterwards).

Intervention Type OTHER

Other Intervention Names

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Bimanual training, HABIT, neurorehabilitation

Eligibility Criteria

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Inclusion Criteria

* willingness to enter the research program and the testing procedures

Exclusion Criteria

* uncontrolled epilepsy
* upper limb injections in the upper limb during the last six months / or intend to receive during the training period
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role collaborator

University Hospital of Mont-Godinne

OTHER

Sponsor Role lead

Responsible Party

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Yannick Bleyenheuft

Scientific collaborator, Institute of Neuroscience UCL

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yannick Bleyenheuft, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Neurosciences, UCL

Corinne Bleyenheuft, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniques Universitaires de Mont-Godinne

Locations

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Institute of Neurosciences, UCL

Brussels, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Yannick Bleyenheuft, PhD

Role: CONTACT

+32486919911

Corinne Bleyenheuft, MD resp.

Role: CONTACT

Facility Contacts

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Yannick Bleyenheuft, PhD

Role: primary

+32486919911

References

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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.

Reference Type DERIVED
PMID: 33647530 (View on PubMed)

Bleyenheuft 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.

Reference Type DERIVED
PMID: 32407247 (View on PubMed)

Bleyenheuft 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.

Reference Type DERIVED
PMID: 25527487 (View on PubMed)

Other Identifiers

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UHMG-IONS-862010

Identifier Type: -

Identifier Source: org_study_id

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