Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures
Primary Purpose
Wrist Fractures, Dizziness
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Vestibular rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Wrist Fractures focused on measuring Wrist fractures, Vestibular asymmetry, Vestibular rehabilitation, Fall-related wrist fractures, Patients 50 years or older
Eligibility Criteria
Inclusion Criteria:
- Fall-related wrist fracture
- 50 years or older
Exclusion Criteria:
- Younger than 50
- Wrist fracture not related to fall
Sites / Locations
- Lund University, Dep Clin Sci in Malmö/Family Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Vestibular rehabilitation, twice a week for 9 weeks
The patients in the control group does nothing, except for normal treatment for their wrist fracture.
Outcomes
Primary Outcome Measures
Vestibular function measured by head shake test
Secondary Outcome Measures
Analyze of gait using electronic walkway
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00988572
Brief Title
Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures
Official Title
Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Fractures, Dizziness
Keywords
Wrist fractures, Vestibular asymmetry, Vestibular rehabilitation, Fall-related wrist fractures, Patients 50 years or older
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Vestibular rehabilitation, twice a week for 9 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients in the control group does nothing, except for normal treatment for their wrist fracture.
Intervention Type
Other
Intervention Name(s)
Vestibular rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vestibular function measured by head shake test
Time Frame
At baseline and at follow-up after 3 months
Secondary Outcome Measure Information:
Title
Analyze of gait using electronic walkway
Time Frame
At baseline and at follow up after 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fall-related wrist fracture
50 years or older
Exclusion Criteria:
Younger than 50
Wrist fracture not related to fall
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Ekvall Hansson, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University, Dep Clin Sci in Malmö/Family Practice
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
10853718
Citation
Kristinsdottir EK, Jarnlo GB, Magnusson M. Asymmetric vestibular function in the elderly might be a significant contributor to hip fractures. Scand J Rehabil Med. 2000 Jun;32(2):56-60. doi: 10.1080/003655000750045550.
Results Reference
background
PubMed Identifier
11508508
Citation
Kristinsdottir EK, Nordell E, Jarnlo GB, Tjader A, Thorngren KG, Magnusson M. Observation of vestibular asymmetry in a majority of patients over 50 years with fall-related wrist fractures. Acta Otolaryngol. 2001 Jun;121(4):481-5.
Results Reference
background
Citation
Hansson, EE. Vestibular Rehabilitation - for whom and how? Advances in Physiotherapy 9:106-116. 2007
Results Reference
background
PubMed Identifier
27142632
Citation
Najafi DA, Dahlberg LE, Hansson EE. A combination of clinical balance measures and FRAX(R) to improve identification of high-risk fallers. BMC Geriatr. 2016 May 3;16:94. doi: 10.1186/s12877-016-0266-6.
Results Reference
derived
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Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures
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