Wrist FracturesNCT00988572
Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures
A study testing Vestibular rehabilitation in people with Wrist Fractures and Dizziness, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wrist Fractures, Dizziness
- What is being tested?
- Vestibular rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2009to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fall-related wrist fracture
- 50 years or older
Who cannot join
- Younger than 50
- Wrist fracture not related to fall
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Lund University, Dep Clin Sci in Malmö/Family Practice
Malmö, 205 02
About this study
Official title: Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures - a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Wrist Fractures, Dizziness
- Being tested
- Vestibular rehabilitation
- Keywords
- Wrist fractures, Vestibular asymmetry, Vestibular rehabilitation, Fall-related wrist fractures, Patients 50 years or older
- Medical subject headings
- Wrist Fractures, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Vestibular rehabilitation, twice a week for 9 weeks Receives: Other: Vestibular rehabilitation |
| Control group | No intervention | The patients in the control group does nothing, except for normal treatment for their wrist fracture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular function measured by head shake test
Measured: At baseline and at follow-up after 3 months
Secondary outcomes (1)
Analyze of gait using electronic walkway
Measured: At baseline and at follow up after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Wrist FracturesStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Ekvall Hansson, Lund University
- Investigators
- Eva Ekvall Hansson, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988572
- Sponsor's protocol ID
- Radius
- Status last verified
- Mar 2015
- First submitted
- 1 Oct 2009
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10853718Kristinsdottir 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.
PubMed 11508508Hansson, EE. Vestibular Rehabilitation - for whom and how? Advances in Physiotherapy 9:106-116. 2007
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.
PubMed 27142632
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00988572
- Acronym / sponsor ID
- Radius
- Conditions
- Wrist Fractures, Dizziness
- Keywords
- Wrist fractures, Vestibular asymmetry, Vestibular rehabilitation, Fall-related wrist fractures, Patients 50 years or older
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Vestibular rehabilitationVestibular rehabilitation, twice a week for 9 weeks |
| Control group | No intervention | –The patients in the control group does nothing, except for normal treatment for their wrist fracture. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fall-related wrist fracture
- 50 years or older
Key exclusion criteria (2 listed)
- Younger than 50
- Wrist fracture not related to fall
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular rehabilitationThe 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. | Other | Intervention group |
Primary outcome
Vestibular function measured by head shake test
Time frame: At baseline and at follow-up after 3 months
1 secondary outcome
Analyze of gait using electronic walkway
Time frame: At baseline and at follow up after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Background: PubMed 10853718Kristinsdottir 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.
- Background: PubMed 11508508Kristinsdottir 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.
- BackgroundHansson, EE. Vestibular Rehabilitation - for whom and how? Advances in Physiotherapy 9:106-116. 2007
- Derived from this study: PubMed 27142632Najafi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Ekvall Hansson, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular rehabilitation in people with Wrist Fractures and Dizziness, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular function measured by head shake test (time frame: At baseline and at follow-up after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00988572, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.