- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03503916
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
Status
Completed
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
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Lund, Sweden, 22100
- Lund University
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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 |
|---|---|---|
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Falls diary
Time Frame: Measures the occurrence of falls during a 12 month period
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A falls diary, where accidental falls during the period is noted by the participant
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Measures the occurrence of falls during a 12 month period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Snubblometer
Time Frame: At baseline
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A wearable device attached to the persons thigh, measures movement patterns
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At baseline
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Timed up and Go
Time Frame: At baseline
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Sitting on a chair, rise up, walk for 3 meter, turn and go back again
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At baseline
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Timed up and Go manual
Time Frame: At baseline
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Sitting on a chair, rise up, walk for 3 meter, turn and go back again while carrying a cup of water
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At baseline
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Timed up and Go cognitive
Time Frame: At baseline
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Sitting on a chair, rise up, walk for 3 meter, turn and go back again while counting down from 100 by 3
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At baseline
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Head shake test
Time Frame: At baseline
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Test of inner ear function by shaking the head for 15 seconds and wearing frenzels
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At baseline
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Dix-Hallpike tess
Time Frame: At baseline
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Wearing frenzels, and testing for BPPV
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At baseline
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Head impulse test
Time Frame: At baseline
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Testing of inner-ear function while wearing frenzels
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At baseline
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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
Keywords
Additional Relevant MeSH Terms
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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