Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures
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| First Received Date ICMJE | October 1, 2009 | ||||||||
| Last Updated Date | February 20, 2013 | ||||||||
| Start Date ICMJE | March 2009 | ||||||||
| Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Vestibular function measured by head shake test [ Time Frame: At baseline and at follow-up after 3 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00988572 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Analyze of gait using electronic walkway [ Time Frame: At baseline and at follow up after 3 months ] [ Designated as safety issue: No ] | ||||||||
| 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 | Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures | ||||||||
| Official Title ICMJE | Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures - a Randomized Controlled Trial | ||||||||
| Brief Summary | Dizziness has been identified as a risk factor for fall and vestibular asymmetry has been found among patients with fall-related wrist fractures as well as among patients with hip-fracture. Since wrist fracture is a risk factor for hip-fracture, much effort is focused on preventing falls for risk-groups. Therefore, it would be interesting to find out if it is possible to influence vestibular asymmetry with vestibular rehabilitation. The aim of this study is therefore to find out if vestibular rehabilitation can have any effect on vestibular function among patients with fall-related wrist fracture. |
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| Detailed Description | Fall-related fractures are an increasing problem for the society. Almost 30% of persons over 65 years of age fall each year. In Sweden 627 persons out of 100 000 is treated in hospitals because of injury after a fall. In Malmö, the figure is 883 persons out of 100 000. However, not all falls lead to a fracture. Dizziness has been identified as a risk factor for fall and vestibular asymmetry has been found among patients with fall-related wrist fractures as well as among patients with hip-fracture. Vestibular rehabilitation programs were first developed in the forties, originally used for peripheral vestibular disorder, in order to facilitate recovery. Modern research has widened the use of vestibular rehabilitation to patients with other causes of dizziness than peripheral vestibular disorders. Since wrist fracture is a risk factor for hip-fracture, much effort is focused on preventing falls for risk-groups. Therefore, it would be interesting to find out if it is possible to influence vestibular asymmetry with vestibular rehabilitation. The aim of this study is therefore to find out if vestibular rehabilitation can have any effect on vestibular function among patients with fall-related wrist fracture. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| 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 |
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| Intervention ICMJE | Other: Vestibular rehabilitation
The intervention program comprises of vestibular rehabilitation, at group sessions, twice a week for 9 weeks. The program is described in detail in table 1. Vestibular rehabilitation aims to facilitate rearrangement and recruitment of the control capacities of the vestibular system, by letting the patient be exposed to unstable body positions, such as standing on foam and performing head, trunk or eye-movements. |
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| Publications * |
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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 | 100 | ||||||||
| Estimated Completion Date | February 2013 | ||||||||
| Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00988572 | ||||||||
| Other Study ID Numbers ICMJE | Radius | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Eva Ekvall Hansson, Lund University | ||||||||
| Study Sponsor ICMJE | Lund University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Lund University | ||||||||
| Verification Date | February 2013 | ||||||||
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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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