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Accidental FallNCT03503916

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

An observational study of Accidental Fall and Postural Balance, run by Lund University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
How many people
113 participants
Where
1 siteSweden
Study dates
27 Feb 2017to 31 Aug 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Lund University

    Lund, 22100

Other trials in Sweden

About this study

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

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.

Read the 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.

Keywords
Accidental fall, Postural Balance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Falls diary

    A falls diary, where accidental falls during the period is noted by the participant

    Measured: Measures the occurrence of falls during a 12 month period

Secondary outcomes (7)

  1. The Snubblometer

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

    Measured: At baseline

  2. Timed up and Go

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

    Measured: At baseline

  3. Timed up and Go manual

    Sitting on a chair, rise up, walk for 3 meter, turn and go back again while carrying a cup of water

    Measured: At baseline

  4. Timed up and Go cognitive

    Sitting on a chair, rise up, walk for 3 meter, turn and go back again while counting down from 100 by 3

    Measured: At baseline

  5. Head shake test

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

    Measured: At baseline

  6. Dix-Hallpike tess

    Wearing frenzels, and testing for BPPV

    Measured: At baseline

  7. Head impulse test

    Testing of inner-ear function while wearing frenzels

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2018
  2. Study start27 Feb 2017
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03503916
Sponsor's protocol ID
2017/56
Status last verified
Oct 2018
First submitted
5 Mar 2018
Last updated
17 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Accidental Fall and Postural Balance, run by Lund University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Falls diary (time frame: Measures the occurrence of falls during a 12 month period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03503916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.

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