SWAY Mobile Application Assessments in Healthy Adults

NCT ID: NCT05616975

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-04-27

Brief Summary

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SWAY Medical, Inc. (SWAY) has developed a mobile application that assesses balance, functional performance, and cognitive function. Clinical reliability, validity, and normative data have been studied extensively in individuals aged 5 to 20. The accuracy of the SWAY Mobile Application in assessing conditions associated with head injury has also been well established. The objectives of this study are to examine the reliability and validity, and establish normative data, for SWAY balance, functional, and cognitive assessments in healthy adults aged 21-90. The SWAY smartphone app will be used to record balance, simple reaction time, impulse control, inspection time, working memory, reverse number counting, flanker task, modified Stroop, and 30 second chair stand test results. The following tests will be administered to participants: Test of Premorbid Functioning, WAIS-IV Logical Memory, WMS-IV Older Adult Logical Memory, Animal Fluency, Boston Naming Test, D-KEFS Color Word Interference Test, WMS-IV Symbol Span, WAIS-IV Coding, Auditory Consonant Trigrams, Verbal Fluency (FAS), and Flanker Inhibitory Control and Attention Test.

Detailed Description

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Specific Aims The objectives of this study are to examine the reliability and validity, and to establish normative data, for SWAY balance, functional, and cognitive assessments in healthy adults aged 21-90.

Aim 1, Hypothesis 1: Sway balance, functional, and cognitive test scores collected at baseline and 30 days will show acceptable test-retest reliabilities.

Aim 2, Hypothesis 2: Sway balance, functional, and cognitive test scores will have medium correlations with psychometrically supported neuropsychological tests of similar constructs (convergent validity) and small correlations with psychometrically supported neuropsychological tests of disparate constructs (discriminant validity).

Aim 3, Hypothesis 3: Sway balance, functional, and cognitive normative test scores will vary significantly across age, education, sex, and race.

Conditions

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Reliability Validity Normative Data

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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reliability

Assessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests

test-retest reliability

Intervention Type OTHER

Assessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests.

validity

Investigating the construct validity of SWAY Balance, Functional, and Cognitive tests

construct validity

Intervention Type OTHER

Investigating the construct validity of SWAY Balance, Functional, and Cognitive tests.

normative

Collection of normative SWAY Balance, Functional, and Cognitive data

normative data

Intervention Type OTHER

Collection of normative SWAY Balance, Functional, and Cognitive data.

Interventions

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test-retest reliability

Assessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests.

Intervention Type OTHER

construct validity

Investigating the construct validity of SWAY Balance, Functional, and Cognitive tests.

Intervention Type OTHER

normative data

Collection of normative SWAY Balance, Functional, and Cognitive data.

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* Uncorrected visual or hearing impairment that interferes with testing
* Alcohol or drug intoxication
* Severe, untreated psychiatric illness (e.g., schizophrenia, bipolar disorder, depression)
* Cognitive impairment (e.g. dementia)
* Motor impairments that may interfere with testing
* Individuals who have a self-reported history of falling or are believed to be at-risk of falling may be excluded from the balance testing portion of the study but will remain eligible to participate in the functional and cognitive assessment portions of the study. Participants over the age of 50 will complete a short fall risk screening assessment.
* Individuals who have a musculoskeletal injury affecting functional movement and balance may be excluded from the balance testing portion of the study but will remain eligible to participate in the cognitive assessment portions of the study.
* Volunteers may also be excluded from portions of this study if they do not have the necessary technology to maintain a Zoom connection required for remotely administered follow-up assessments, and a smart-device capable of downloading and operating the SWAY application.
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SWAY Medical, Inc

UNKNOWN

Sponsor Role collaborator

College of Medicine Alumni Association

UNKNOWN

Sponsor Role collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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OU IRB 14031

Identifier Type: -

Identifier Source: org_study_id

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