NCT05616975

SWAY Mobile Application Assessments in Healthy Adults

Reliability, Validity, Normative Data, and Accuracy of SWAY Mobile Application Assessments in Healthy Adults

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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

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

• Reliability
• Validity
• Normative Data

Interventions

Type	Name	Description
OTHER	test-retest reliability	Assessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests.
OTHER	construct validity	Investigating the construct validity of SWAY Balance, Functional, and Cognitive tests.
OTHER	normative data	Collection of normative SWAY Balance, Functional, and Cognitive data.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-04-27
• Completion: 2023-04-27
• First posted: 2022-11-15
• Last updated: 2024-03-29

Regulatory

• FDA-regulated device study