The Relation Between Movement Patterns, Balance Performance, Function of the Inner Ear and Falls

October 16, 2018 updated by: Eva Ekvall-Hansson, Lund University

The Relation Between Movement Patterns, Balance Performance, Function of the Inner Ear and Falls Among Healthy Older People - a Observation Study With 12 Months Follow up

Falls are one of the most common reasons for immobilisation and death in elderly population. This study aims at studying falls among a group of older people. The aim is to study the relation between movement patterns, balance performance, inner ear function and future falls. Senior member will be recruited through the non-profit association "Friskis&Svettis. Measures of movement patterns, balance performance and innear ear function will be measured at baseline. Falls will be monitored through falls diaries, collected every third month during a 12 month period.

Study Overview

Detailed Description

Falls are one of the most common reasons for immobilisation and death in elderly population. They will be even more essential to address when large birth cohorts grow older and life expectancy increases. Number of elderly persons is constantly rising. When in 2010 there was 1730 000 over 65-year olds in Sweden, the prognosis for year 2060 is 3221 000 persons. Hence, it is important to find solutions for preventing falls. The aim of this project is to study the relation between movement patterns, balance performance, inner ear function and future falls. After measuring movement patterns, inner ear function and balance at baseline, falls will be monitored through falls diaries, collected every third month during a twelve month period in a group of older persons, recruited through the non-profit association "Friskis&Svettis" in Malmö, Sweden. The study population will consist of senior members in the association, invited to workshops about balance.

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lund, Sweden, 22100
        • Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Senior members of the non-profit association Friskis&Svettis in Malmö Sweden, invited at three occasions where workshops about balance was held.

Description

Inclusion Criteria:

  • Men and women, 65 years and older
  • The ability to ability to speak and understand Swedish language.

Exclusion Criteria:

  • Age younger than 65
  • Not able to speak and understand Swedish language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls diary
Time Frame: Measures the occurrence of falls during a 12 month period
A falls diary, where accidental falls during the period is noted by the participant
Measures the occurrence of falls during a 12 month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Snubblometer
Time Frame: At baseline
A wearable device attached to the persons thigh, measures movement patterns
At baseline
Timed up and Go
Time Frame: At baseline
Sitting on a chair, rise up, walk for 3 meter, turn and go back again
At baseline
Timed up and Go manual
Time Frame: At baseline
Sitting on a chair, rise up, walk for 3 meter, turn and go back again while carrying a cup of water
At baseline
Timed up and Go cognitive
Time Frame: At baseline
Sitting on a chair, rise up, walk for 3 meter, turn and go back again while counting down from 100 by 3
At baseline
Head shake test
Time Frame: At baseline
Test of inner ear function by shaking the head for 15 seconds and wearing frenzels
At baseline
Dix-Hallpike tess
Time Frame: At baseline
Wearing frenzels, and testing for BPPV
At baseline
Head impulse test
Time Frame: At baseline
Testing of inner-ear function while wearing frenzels
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2017

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 16, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2017/56

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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