Balance; DistortedNCT04700605
Intra-rater Reliability and Agreement Between Two Dual Task Tests; WBB and Gait Test.
An observational study of Balance; Distorted, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Agreement and intra-rater reliability between static balance test using Nintendo Wii Balance Board and gait test under dual-task conditions in community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Balance; Distorted
- What is being tested?
- Dual task balance test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Oct 2020to 6 Jan 2021
- How long will I take part?
- 2 Weeks
- 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: Minimum 65 year-old community dwelling citizens at activity centers.
Who may be able to join
- Minimum 65 years old.
- Community dwelling
Who cannot join
- Unable to stand unsupported for 30 seconds
- Unable to walk 8 meters unsupported
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Liselund Aktivitets Center
Vodskov, Aalborg, 9310
Elstrøm, 004599313298, qr-aeh@aalborg.dk
About this study
Official title: Intra-rater Reliability and Agreement Between Static Balance Test Using Nintendo Wii Balance Board and Gait Test Under Dual Task Conditions in Community-dwelling Older Adults.
Agreement and intra-rater reliability between static balance test using Nintendo Wii Balance Board and gait test under dual-task conditions in community-dwelling older adults.
Read the detailed description
Participants:
Investigators aim to recruit a minimum of 30 participants aged 65 years or above through convenience sampling at an senior activity centre in the Municipality of Aalborg. Participants inclusion critiria is age about 65, the ability to stand for 30 seconds unaided and the ability to walk 8 meters. Exclusion critiria is severe cognitive impairment (e.g., dementia).
Procedure:
Each participant will undergo two testdays separated by approximately two weeks. Both testdays have the same number and order of tests and are placed approximately the same time of the day. At the first testday descriptive information for each participant is collected.
Measuring device:
The Nintendo Wii Balance Board (Nintendo, Kyoto, Japan) is a small portable force plate measuring sway ellipse area and sway speed.
Analysis:
Will include intra-rater reliability for each test and agreement between the two. Calculations of balance/gait costs will be made to unify the unit and to compare the two tests to each other. Results shown by intraclass correlation coeffients and Bland Altman plots.
- Conditions
- Balance; Distorted
- Being tested
- Dual task balance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual task balance testBehavioural
Participants will be conducting two dual task tests; an 8m gait test and a Wii Balance Board test with simultaneous various cognitive tests.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-rater reliability for the gait test and the WBB test.
Comparing the dual task costs for each test between test and retest. Assessments through intraclass correlation coefficient and reportings in accordance with Guidelines for Reporting Reliability and Agreement Studies (GRRAS).
Measured: Through study completion, app. 8 months.
Secondary outcomes (2)
Agreement between the gait test and the WBB test as dual task measurements.
Comparing the dual task costs between the gait test and the Wii Balance Board test. Data assessment through Bland Altman plots and reportings in accordance with Guidelines for Reporting Reliability and Agreement Studies (GRRAS).
Measured: Through study completion, app. 8 months.
Descriptive data.
Qustionnairies consisting of Tilburg Frailty Indicator, Vulnerable Elders Survey 13, Short Falls Efficacy Scale, previous falls, medications and Orientations-Memory-Concentrations test. Data assessment through histograms and Shapiro Wilk tests and reported by means and standard deviations, medians and interquartile ranges, and numbers and percentages.
Measured: Through study completion, app. 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start27 Oct 2020
- Primary completion6 Jan 2021 (estimated)
- Study completion6 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance; DistortedStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Eriksen, Aalborg University Hospital
- Investigators
- Martin Eriksen, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700605
- Sponsor's protocol ID
- 2020-096
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-rater Reliability and Agreement Between Static Balance Test Using Nintendo Wii Balance Board and Gait Test Under Dual Task Conditions in Community-dwelling Older Adults.
- ClinicalTrials.gov ID
- NCT04700605
- Acronym / sponsor ID
- 2020-096
- Conditions
- Balance; Distorted
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 6 Jan 2021 (estimated)
- Study completion
- 6 Jan 2021 (estimated)
- First posted
- 8 Jan 2021 (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.
Agreement and intra-rater reliability between static balance test using Nintendo Wii Balance Board and gait test under dual-task conditions in community-dwelling older adults.
Detailed description
Participants:
Investigators aim to recruit a minimum of 30 participants aged 65 years or above through convenience sampling at an senior activity centre in the Municipality of Aalborg. Participants inclusion critiria is age about 65, the ability to stand for 30 seconds unaided and the ability to walk 8 meters. Exclusion critiria is severe cognitive impairment (e.g., dementia).
Procedure:
Each participant will undergo two testdays separated by approximately two weeks. Both testdays have the same number and order of tests and are placed approximately the same time of the day. At the first testday descriptive information for each participant is collected.
Measuring device:
The Nintendo Wii Balance Board (Nintendo, Kyoto, Japan) is a small portable force plate measuring sway ellipse area and sway speed.
Analysis:
Will include intra-rater reliability for each test and agreement between the two. Calculations of balance/gait costs will be made to unify the unit and to compare the two tests to each other. Results shown by intraclass correlation coeffients and Bland Altman plots.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Minimum 65 year-old community dwelling citizens at activity centers.
Key inclusion criteria (2 listed)
- Minimum 65 years old.
- Community dwelling
Key exclusion criteria (2 listed)
- Unable to stand unsupported for 30 seconds
- Unable to walk 8 meters unsupported
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual task balance testParticipants will be conducting two dual task tests; an 8m gait test and a Wii Balance Board test with simultaneous various cognitive tests. | Behavioural | – |
Primary outcome
Intra-rater reliability for the gait test and the WBB test.
Time frame: Through study completion, app. 8 months.
Comparing the dual task costs for each test between test and retest. Assessments through intraclass correlation coefficient and reportings in accordance with Guidelines for Reporting Reliability and Agreement Studies (GRRAS).
2 secondary outcomes
Agreement between the gait test and the WBB test as dual task measurements.
Time frame: Through study completion, app. 8 months.
Descriptive data.
Time frame: Through study completion, app. 8 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Martin Eriksen principal investigator
Aalborg University Hospital
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 Balance; Distorted, run by Aalborg University Hospital at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 8 Jan 2021. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eriksen, student (004522234454, martin.eriksen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-rater reliability for the gait test and the WBB test. (time frame: Through study completion, app. 8 months.). 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 8 Jan 2021.