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

• ClinicalTrials.gov Identifier: NCT01700777
• Recruitment Status: Unknown
• First Posted: October 4, 2012
• Last Update Posted: January 22, 2014
• Sponsor: University Hospital of Mont-Godinne
• Collaborator: Université Catholique de Louvain
• Information provided by (Responsible Party): Yannick Bleyenheuft, University Hospital of Mont-Godinne

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.

Condition or disease	Intervention/treatment	Phase
Congenital Hemiplegia	Other: "HABIT-ILE"	Phase 1; Phase 2

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: November 2010
• Estimated Primary Completion Date: January 2014
• Estimated Study Completion Date: January 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intensive rehab group; A group of children will beneficiate of "HABIT-ILE" treatment in an intensive way (camp) for 90h.	Other: "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).; Other Name: Bimanual training, HABIT, neurorehabilitation
Active Comparator: 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.	Other: "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).; Other Name: Bimanual training, HABIT, neurorehabilitation

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Yannick Bleyenheuft, PhD; +32486919911; yannick.bleyenheuft@gmail.com

Contact: Corinne Bleyenheuft, MD resp.; corinne.bleyenheuft@uclouvain.be

Locations

Belgium

Institute of Neurosciences, UCL; Recruiting

Brussels, Belgium, 1200

Contact: Yannick Bleyenheuft, PhD +32486919911 yannick.bleyenheuft@gmail.com

Principal Investigator: Yannick Bleyenheuft, PhD

Sponsors and Collaborators

University Hospital of Mont-Godinne

Université Catholique de Louvain

Investigators

• Principal Investigator: Yannick Bleyenheuft, PhD; Institute of Neurosciences, UCL
• Principal Investigator: Corinne Bleyenheuft, MD; Cliniques Universitaires de Mont-Godinne

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Yannick Bleyenheuft, Scientific collaborator, Institute of Neuroscience UCL, University Hospital of Mont-Godinne
• ClinicalTrials.gov Identifier: NCT01700777
• Other Study ID Numbers: UHMG-IONS-862010
• First Posted: October 4, 2012
• Last Update Posted: January 22, 2014
• Last Verified: January 2014

Keywords provided by Yannick Bleyenheuft, University Hospital of Mont-Godinne:

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

Additional relevant MeSH terms:

Hemiplegia; Paralysis; Neurologic Manifestations; Nervous System Diseases