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Intra-rater Reliability and Agreement Between Two Dual Task Tests; WBB and Gait Test.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04700605
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Martin Eriksen, Aalborg University Hospital

Brief 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.

Condition or disease Intervention/treatment
Balance; Distorted Behavioral: Dual task balance test

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Weeks
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.
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : January 6, 2021
Estimated Study Completion Date : January 6, 2021

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Minimum 65 year-old community dwelling citizens at activity centers.
Criteria

Inclusion Criteria:

  • Minimum 65 years old.
  • Community dwelling

Exclusion Criteria:

  • Unable to stand unsupported for 30 seconds
  • Unable to walk 8 meters unsupported

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700605


Contacts
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Contact: Eriksen, student 004522234454 martin.eriksen@rn.dk
Contact: Gade, MD 004552505753 gustav.soerensen@rn.dk

Locations
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Denmark
Liselund Aktivitets Center Recruiting
Vodskov, Aalborg, Denmark, 9310
Contact: Elstrøm    004599313298    qr-aeh@aalborg.dk   
Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Principal Investigator: Martin Eriksen Aalborg University Hospital
  Study Documents (Full-Text)

Documents provided by Martin Eriksen, Aalborg University Hospital:
Study Protocol  [PDF] October 27, 2020

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Responsible Party: Martin Eriksen, Medical student, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04700605    
Other Study ID Numbers: 2020-096
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No