Clincosm LogoSign in Get a demo

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

Sponsor
Lund University (Other)
Overall Status
Completed
CT.gov ID
NCT03503916
Collaborator
(none)
113
Enrollment
1
Location
18.1
Actual Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Feb 27, 2017
    Actual Primary Completion Date :
    Aug 31, 2018
    Actual Study Completion Date :
    Aug 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Falls diary [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 [At baseline]

      A wearable device attached to the persons thigh, measures movement patterns

    2. Timed up and Go [At baseline]

      Sitting on a chair, rise up, walk for 3 meter, turn and go back again

    3. Timed up and Go manual [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 [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 [At baseline]

      Test of inner ear function by shaking the head for 15 seconds and wearing frenzels

    6. Dix-Hallpike tess [At baseline]

      Wearing frenzels, and testing for BPPV

    7. Head impulse test [At baseline]

      Testing of inner-ear function while wearing frenzels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Lund University Lund Sweden 22100

    Sponsors and Collaborators

    • Lund University

    Investigators

    • Principal Investigator: Eva Ekvall Hansson, PhD, Lund University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eva Ekvall-Hansson, Senior lecturer, Lund University
    ClinicalTrials.gov Identifier:
    NCT03503916
    Other Study ID Numbers:
    • 2017/56
    First Posted:
    Apr 20, 2018
    Last Update Posted:
    Oct 17, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eva Ekvall-Hansson, Senior lecturer, Lund University
    Accidental fall
    Postural Balance
    Additional relevant MeSH terms:
    Movement Disorders

    Study Results

    No Results Posted as of Oct 17, 2018