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

Phase 1

• Conditions: Congenital Hemiplegia
• Interventions: Other: "HABIT-ILE"

• Registration Number: NCT01700777
• Lead Sponsor: University Hospital of Mont-Godinne

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive rehab group	"HABIT-ILE"	A group of children will beneficiate of "HABIT-ILE" treatment in an intensive way (camp) for 90h.
Regular treatment group	"HABIT-ILE"	A group of children with hemiplegic cerebral palsy will beneficiate from conventional training at a regular frequency (1 to 6 hours / week) for 90hours.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institute of Neurosciences, UCL; 🇧🇪 Brussels, Belgium