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.
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
- Conditions the study is for
- Accidental Fall, Postural Balance, Movement Disorders in Old Age
- 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.
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.
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)
The Snubblometer
A wearable device attached to the persons thigh, measures movement patterns
Measured: At baseline
Timed up and Go
Sitting on a chair, rise up, walk for 3 meter, turn and go back again
Measured: At baseline
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
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
Head shake test
Test of inner ear function by shaking the head for 15 seconds and wearing frenzels
Measured: At baseline
Dix-Hallpike tess
Wearing frenzels, and testing for BPPV
Measured: At baseline
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.
- First posted20 Apr 2018
- Study start27 Feb 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Ekvall-Hansson, Lund University
- Investigators
- Eva Ekvall Hansson, PhD, Principal investigator, Lund University
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03503916
- Acronym / sponsor ID
- 2017/56
- Keywords
- Accidental fall, Postural Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Men and women, 65 years and older
- The ability to ability to speak and understand Swedish language.
Key exclusion criteria (2 listed)
- Age younger than 65
- Not able to speak and understand Swedish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
The Snubblometer
Time frame: At baseline
Timed up and Go
Time frame: At baseline
Timed up and Go manual
Time frame: At baseline
Timed up and Go cognitive
Time frame: At baseline
Head shake test
Time frame: At baseline
Dix-Hallpike tess
Time frame: At baseline
Head impulse test
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Accidental Fall
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Effects of a Novel Perturbation Balance Training Program on Laboratory and Real-World Trip-Induced Losses of Balance and Falls Among Balance-Impaired Older Adults
Accidental Fall
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Enrolling by invitation
Preventing Loss of Independence Through Exercise in Community Living Centers
Dementia, Cognitive Dysfunction
Not yet recruitingObservational study
Turkish Adaptation of the Multidimensional Falls Efficacy Scale in Older Adults
Balance Control in Elderly, Falls (Accidents) in Old Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Ekvall Hansson, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
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?
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.