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

This study is currently recruiting participants.
Verified January 2014 by University Hospital of Mont-Godinne
Sponsor:
Collaborator:
Université Catholique de Louvain
Information provided by (Responsible Party):
Yannick Bleyenheuft, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier:
NCT01700777
First received: October 2, 2012
Last updated: January 21, 2014
Last verified: January 2014

October 2, 2012
January 21, 2014
November 2010
January 2014   (final data collection date for primary outcome measure)
Impairment, disability, participation [ Time Frame: 4 years ] [ Designated as safety issue: No ]
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.
Impairement, disability, participation [ Time Frame: 4 years ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01700777 on ClinicalTrials.gov Archive Site
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Bimanual Training in Children With Hemiplegia With Lower Limb and Postural Stimulation (HABIT & Leg)
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).

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Congenital Hemiplegia
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
  • Experimental: Intensive rehab group
    A group of children will beneficiate of "HABIT-ILE" treatment in an intensive way (camp) for 90h.
    Intervention: Other: "HABIT-ILE"
  • 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.
    Intervention: Other: "HABIT-ILE"
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
5 Years to 18 Years
Yes
Contact: Yannick Bleyenheuft, PhD +32486919911 yannick.bleyenheuft@gmail.com
Contact: Corinne Bleyenheuft, MD resp. corinne.bleyenheuft@uclouvain.be
Belgium
 
NCT01700777
UHMG-IONS-862010
Yes
Yannick Bleyenheuft, University Hospital of Mont-Godinne
University Hospital of Mont-Godinne
Université Catholique de Louvain
Principal Investigator: Yannick Bleyenheuft, PhD Institute of Neurosciences, UCL
Principal Investigator: Corinne Bleyenheuft, MD Cliniques Universitaires de Mont-Godinne
University Hospital of Mont-Godinne
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP