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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
Congenital Hemiplegia
Other: "HABIT-ILE"
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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).

Resource links provided by NLM:


Further study details as provided by University Hospital of Mont-Godinne:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Bimanual training, HABIT, neurorehabilitation

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700777

Contacts
Contact: Yannick Bleyenheuft, PhD +32486919911 yannick.bleyenheuft@gmail.com
Contact: Corinne Bleyenheuft, MD resp. corinne.bleyenheuft@uclouvain.be

Locations
Belgium
Institute of Neurosciences, UCL Recruiting
Brussels, Belgium, 1200
Contact: Yannick Bleyenheuft, PhD    +32486919911    yannick.bleyenheuft@gmail.com   
Principal Investigator: Yannick Bleyenheuft, PhD         
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
  More Information

No publications provided

Responsible Party: Yannick Bleyenheuft, Scientific collaborator, Institute of Neuroscience UCL, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT01700777     History of Changes
Other Study ID Numbers: UHMG-IONS-862010
Study First Received: October 2, 2012
Last Updated: January 21, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital of Mont-Godinne:
bimanual training
lower limb
intensive rehabilitation
regular rehabilitation
hemiplegia

Additional relevant MeSH terms:
Hemiplegia
Cerebral Palsy
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on October 02, 2014