NCT00988572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

3.9 years

First QC Date

October 1, 2009

Last Update Submit

March 30, 2015

Conditions

Wrist FracturesDizziness

Keywords

Wrist fracturesVestibular asymmetryVestibular rehabilitationFall-related wrist fracturesPatients 50 years or older

Outcome Measures

Primary Outcomes (1)

  • Vestibular function measured by head shake test

    At baseline and at follow-up after 3 months

Secondary Outcomes (1)

  • Analyze of gait using electronic walkway

    At baseline and at follow up after 3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Vestibular rehabilitation, twice a week for 9 weeks

Other: Vestibular rehabilitation

Control group

NO INTERVENTION

The patients in the control group does nothing, except for normal treatment for their wrist fracture.

Interventions

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.

Intervention group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fall-related wrist fracture
  • years or older

You may not qualify if:

  • Younger than 50
  • Wrist fracture not related to fall

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University, Dep Clin Sci in Malmö/Family Practice

Malmo, 205 02, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 10853718BACKGROUND

  • 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.

    PMID: 11508508BACKGROUND

  • Hansson, EE. Vestibular Rehabilitation - for whom and how? Advances in Physiotherapy 9:106-116. 2007

    BACKGROUND

  • 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.

    PMID: 27142632DERIVED

MeSH Terms

Conditions

Wrist FracturesDizziness

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eva Ekvall Hansson, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2013

Study Completion

March 1, 2014

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

SE(1)