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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04700605
Other study ID # 2020-096
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 27, 2020
Est. completion date January 6, 2021

Study information

Verified date January 2021
Source Aalborg University Hospital
Contact Eriksen, student
Phone 004522234454
Email martin.eriksen@rn.dk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 6, 2021
Est. primary completion date January 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Minimum 65 years old. - Community dwelling Exclusion Criteria: - Unable to stand unsupported for 30 seconds - Unable to walk 8 meters unsupported

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dual task balance test
Participants will be conducting two dual task tests; an 8m gait test and a Wii Balance Board test with simultaneous various cognitive tests.

Locations

Country Name City State
Denmark Liselund Aktivitets Center Vodskov Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Through study completion, app. 8 months.
Secondary 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). Through study completion, app. 8 months.
Secondary 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. Through study completion, app. 8 months.
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