Light Constraint Induced Therapy Experiment (LICITE)
| Tracking Information | |||||
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| First Received Date ICMJE | February 6, 2009 | ||||
| Last Updated Date | January 9, 2012 | ||||
| Start Date ICMJE | February 2009 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Motor activity log scale [ Time Frame: 10 days before inclusion, 10 days and 3 months after treatment achievement ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00839670 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Wolf Motor Function test Stroke impact scale Functional MRI HAD scale [ Time Frame: 10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month) ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Light Constraint Induced Therapy Experiment | ||||
| Official Title ICMJE | Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial. | ||||
| Brief Summary | The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method. |
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| Detailed Description | Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. However, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit. The aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by Taub et al. (360 minutes of motor training with a physical or occupational therapist). Patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. The treatment will last two weeks, five days per week. The evaluations will include clinical measure of motor function and functional MRI of the brain. The brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Stroke | ||||
| Intervention ICMJE |
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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 | Terminated | ||||
| Enrollment ICMJE | 34 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00839670 | ||||
| Other Study ID Numbers ICMJE | P070161 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | February 2009 | ||||
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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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