- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04700605
Intra-rater Reliability and Agreement Between Two Dual Task Tests; WBB and Gait Test.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Eriksen, student
- Phone Number: 004522234454
- Email: martin.eriksen@rn.dk
Study Contact Backup
- Name: Gade, MD
- Phone Number: 004552505753
- Email: gustav.soerensen@rn.dk
Study Locations
-
-
Aalborg
-
Vodskov, Aalborg, Denmark, 9310
- Recruiting
- Liselund Aktivitets Center
-
Contact:
- Elstrøm
- Phone Number: 004599313298
- Email: qr-aeh@aalborg.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Minimum 65 years old.
- Community dwelling
Exclusion Criteria:
- Unable to stand unsupported for 30 seconds
- Unable to walk 8 meters unsupported
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Through study completion, app. 8 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement between the gait test and the WBB test as dual task measurements.
Time Frame: Through study completion, app. 8 months.
|
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).
|
Through study completion, app. 8 months.
|
|
Descriptive data.
Time Frame: Through study completion, app. 8 months.
|
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.
|
Through study completion, app. 8 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin Eriksen, Aalborg University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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