Clinical trial NCT01700777: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Congenital Hemiplegia
Keywords: bimanual training
lower limb
intensive rehabilitation
regular rehabilitation
hemiplegia
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
Collaborators: name: Université Catholique de Louvain
First posted: 2012-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Impairment, disability, participation
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institute of Neurosciences, UCL
Study officials:
affiliation: Institute of Neurosciences, UCL
name: Yannick Bleyenheuft, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques Universitaires de Mont-Godinne
name: Corinne Bleyenheuft, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.