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

Primary Purpose

Congenital Hemiplegia

Status

Unknown status

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

"HABIT-ILE"

About this trial

This is an interventional treatment trial for Congenital Hemiplegia focused on measuring bimanual training, lower limb, intensive rehabilitation, regular rehabilitation, hemiplegia

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Institute of Neurosciences, UCLRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive rehab group

Regular treatment group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01700777

First Posted

October 2, 2012

Last Updated

January 21, 2014

Sponsor

University Hospital of Mont-Godinne

Collaborators

Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT01700777

Brief Title

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

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).

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2010 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital of Mont-Godinne

Collaborators

Université Catholique de Louvain

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Hemiplegia

Keywords

bimanual training, lower limb, intensive rehabilitation, regular rehabilitation, hemiplegia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intensive rehab group

Arm Type

Experimental

Arm Description

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

Arm Title

Regular treatment group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

"HABIT-ILE"

Other Intervention Name(s)

Bimanual training, HABIT, neurorehabilitation

Intervention Description

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

Primary Outcome Measure Information:

Title

Impairment, disability, participation

Description

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yannick Bleyenheuft, PhD

Phone

+32486919911

yannick.bleyenheuft@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Corinne Bleyenheuft, MD resp.

corinne.bleyenheuft@uclouvain.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yannick Bleyenheuft, PhD

Organizational Affiliation

Institute of Neurosciences, UCL

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Corinne Bleyenheuft, MD

Organizational Affiliation

Cliniques Universitaires de Mont-Godinne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Neurosciences, UCL

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yannick Bleyenheuft, PhD

Phone

+32486919911

yannick.bleyenheuft@gmail.com

First Name & Middle Initial & Last Name & Degree

Yannick Bleyenheuft, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

33647530

Citation

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.

Results Reference

derived

PubMed Identifier

32407247

Citation

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.

Results Reference

derived

PubMed Identifier

25527487

Citation

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.

Results Reference

derived

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

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