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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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Hemiplegia |
Other: "HABIT and leg" |
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:
- 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.
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intensive rehab group
A group of children will beneficiate of "HABIT&leg" treatment in an intensive way (camp) for 90h.
|
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
|
|
Active Comparator: Regular treatment group
A group of children with hemiplegic cerebral palsy will beneficiate from "HABIT & leg" training at a regular frequency (1 to 6 hours / week) for 90hours.
|
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
|
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.
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
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: | October 2, 2012 |
| 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 May 22, 2013