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

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ClinicalTrials.gov Identifier: NCT01700777
Recruitment Status : Unknown
Verified January 2014 by Yannick Bleyenheuft, University Hospital of Mont-Godinne.
Recruitment status was:  Recruiting
First Posted : October 4, 2012
Last Update Posted : January 22, 2014
Sponsor:
Collaborator:
Université Catholique de Louvain
Information provided by (Responsible Party):
Yannick Bleyenheuft, University Hospital of Mont-Godinne

Tracking Information
First Submitted Date  ICMJE October 2, 2012
First Posted Date  ICMJE October 4, 2012
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2014)		 Impairment, disability, participation [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)		 Impairement, disability, participation [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bimanual Training in Children With Hemiplegia With Lower Limb and Postural Stimulation (HABIT & Leg)
Official Title  ICMJE 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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Congenital Hemiplegia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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"
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 2, 2012)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2014
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01700777
Other Study ID Numbers  ICMJE UHMG-IONS-862010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yannick Bleyenheuft, University Hospital of Mont-Godinne
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital of Mont-Godinne
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Université Catholique de Louvain
Investigators  ICMJE
Principal Investigator: Yannick Bleyenheuft, PhD Institute of Neurosciences, UCL
Principal Investigator: Corinne Bleyenheuft, MD Cliniques Universitaires de Mont-Godinne
PRS Account University Hospital of Mont-Godinne
Verification Date January 2014

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