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| Descriptive Information Fields | |||||||||
| Brief Title † | Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial | ||||||||
| Official Title † | Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial | ||||||||
| Brief Summary | The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling. |
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| Detailed Description | Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Single Group Assignment | ||||||||
| Primary Outcome Measure † | Change in Active Range of Motion of Hallux (great toe) Extension [ Time Frame: Two Months ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Change in passive Range of Motion, Extension [ Time Frame: same ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Hallux Limitus | ||||||||
| Intervention † | Device: Metatarsophalangeal Extension Dynasplint System Other: Standard of Care |
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| MEDLINE PMIDs | 17144945, 10416546, 17296132, 15778469, 12015407, 16467621, 12095117, 17972321, 11475452 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 50 | ||||||||
| Start Date † | July 2008 | ||||||||
| Completion Date | December 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00717691 | ||||||||
| Organization ID | 2008.003 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Dynasplint Systems, Inc. | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Dynasplint Systems, Inc. | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | July 15, 2008 | ||||||||
| Last Updated Date | July 16, 2008 | ||||||||
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