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

Congenital Hemiplegia Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01700777
• Other study ID #: UHMG-IONS-862010
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 2, 2012
• Last updated: January 21, 2014
• Start date: November 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: University Hospital of Mont-Godinne
• Contact: Yannick Bleyenheuft, PhD
• Phone: +32486919911
• Email: yannick.bleyenheuft[@]gmail.com
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Hemiplegia
• Hemiplegia

Intervention

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).

Locations

Country	Name	City	State
Belgium	Institute of Neurosciences, UCL	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne	Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 years	No