Bimanual Training in Children With Hemiplegia With Lower Limb and Postural Stimulation (HABIT & Leg)
This study is currently recruiting participants.
Verified October 2012 by University Hospital of Mont-Godinne
Sponsor:
University Hospital of Mont-Godinne
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: NA
Last verified: October 2012
History: No changes posted
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| First Received Date ICMJE | October 2, 2012 | ||||||||
| Last Updated Date | October 2, 2012 | ||||||||
| Start Date ICMJE | November 2010 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | 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 & leg" therapy at regular or intensive frequency. The protocols have been developped on the basis of bimanual therapy (HABIT) developped at Columbia University. |
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| Detailed Description | A randomized control trial of "HABIT & leg" therapy at regular or intensive frequency. The protocols have been developed on the basis of bimanual therapy (HABIT) developped at Columbia University. The interventions take place either in a 2 weeks day and night camp, either in regular intervention (1 to 5 hours a week). The study is also designed to contrast results with regular NDT treatments. Children of all groups will beneficiate from 90h of treatment. Both in the camp and the regular interventions, there is at least one therapist for each child. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Congenital Hemiplegia | ||||||||
| Intervention ICMJE | Other: "HABIT and leg"
90 h of training with "HABIT & leg", either in an intensive rehabilitation camp or in regular therapy program.
Other Name: Bimanual training, HABIT, neurorehabilitation |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Belgium | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01700777 | ||||||||
| Other Study ID Numbers ICMJE | UHMG-IONS-862010 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Yannick Bleyenheuft, University Hospital of Mont-Godinne | ||||||||
| Study Sponsor ICMJE | University Hospital of Mont-Godinne | ||||||||
| Collaborators ICMJE | Université Catholique de Louvain | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital of Mont-Godinne | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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