Study to Investigate the Added Value of a Rehabilitation Brace in the Treatment at Home After a Fracture of the Ankle
This study has been withdrawn prior to enrollment.
Sponsor:
University Hospital, Ghent
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00284349
First received: January 30, 2006
Last updated: May 18, 2009
Last verified: April 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 30, 2006 | ||||
| Last Updated Date | May 18, 2009 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Mobility of the ankle [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Agility of the ankle | ||||
| Change History | Complete list of historical versions of study NCT00284349 on ClinicalTrials.gov Archive Site | ||||
| 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 | Study to Investigate the Added Value of a Rehabilitation Brace in the Treatment at Home After a Fracture of the Ankle | ||||
| Official Title ICMJE | Study to Investigate the Added Value of a Rehabilitation Brace in the Treatment at Home After a Fracture of the Ankle | ||||
| Brief Summary | Comparison between immobilisation by a plaster and a rehabilitation brace for the treatment of a fracture of the ankle |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Fracture of the Ankle | ||||
| Intervention ICMJE | Device: Use of a rehabilitation brace instead of a plaster | ||||
| Study Arm (s) | Not Provided | ||||
| 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 | Withdrawn | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| 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 | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00284349 | ||||
| Other Study ID Numbers ICMJE | 2005/043 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | René Verdonk, University Hospital Ghent | ||||
| Study Sponsor ICMJE | University Hospital, Ghent | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Ghent | ||||
| Verification Date | April 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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