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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03503916
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Eva Ekvall-Hansson, Lund University

Study Description
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Brief Summary:
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.

Condition or disease
Accidental Fall Postural Balance Movement Disorders in Old Age

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 Design
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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The Snubblometer [ Time Frame: At baseline ]
    A wearable device attached to the persons thigh, measures movement patterns

  2. Timed up and Go [ Time Frame: At baseline ]
    Sitting on a chair, rise up, walk for 3 meter, turn and go back again

  3. 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

  4. 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

  5. Head shake test [ Time Frame: At baseline ]
    Test of inner ear function by shaking the head for 15 seconds and wearing frenzels

  6. Dix-Hallpike tess [ Time Frame: At baseline ]
    Wearing frenzels, and testing for BPPV

  7. Head impulse test [ Time Frame: At baseline ]
    Testing of inner-ear function while wearing frenzels


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503916


Locations
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Sweden
Lund University
Lund, Sweden, 22100
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Eva Ekvall Hansson, PhD Lund University
More Information
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Responsible Party: Eva Ekvall-Hansson, Senior lecturer, Lund University
ClinicalTrials.gov Identifier: NCT03503916    
Other Study ID Numbers: 2017/56
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eva Ekvall-Hansson, Lund University:
Accidental fall
Postural Balance
Additional relevant MeSH terms:
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Movement Disorders
Central Nervous System Diseases
Nervous System Diseases