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

Sponsor

University Hospital of Mont-Godinne (Other)

Overall Status

Unknown status

CT.gov ID

NCT01700777

Collaborator

Université Catholique de Louvain (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Nov 1, 2010

Anticipated Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Jan 1, 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 Names: 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 Names: Bimanual training, HABIT, neurorehabilitation

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 Names:

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 Names:

Bimanual training, HABIT, neurorehabilitation

Outcome Measures

Primary Outcome Measures

Impairment, disability, participation [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

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Institute of Neurosciences, UCL	Brussels		Belgium	1200

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