SWAY Mobile Application Assessments in Healthy Adults

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Reliability; Validity; Normative Data
• Intervention / Treatment: Other: test-retest reliability; Other: construct validity; Other: normative data

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.

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants:

Not less than seven hundred (700) and up to one thousand (1000) men and women from the University of Oklahoma. OU students, residents, staff, faculty, and patients will be recruited through flyers posted and distributed on campus, in clinics, on social media and through emails. Additional participants will be recruited from the community as needed via flyers distributed at local hospitals, clinics, senior living facilities, and through newspaper and radio advertisements.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
reliability; Assessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests	Other: test-retest reliability; Assessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests.
validity; Investigating the construct validity of SWAY Balance, Functional, and Cognitive tests	Other: construct validity; Investigating the construct validity of SWAY Balance, Functional, and Cognitive tests.
normative; Collection of normative SWAY Balance, Functional, and Cognitive data	Other: normative data; Collection of normative SWAY Balance, Functional, and Cognitive data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance Assessments	i. Modified balance error scoring system protocol (mBESS) in individuals less than 55 years of age ii. CDC 4-stage Balance test for individuals greater than or equal to 55 years of age	<15 minutes
Functional Assessments	i. SWAY 30 Second Chair Stand Test (functional)	<15 minutes
Cognitive Assessments	i. SWAY Memory (visual working memory) ii. SWAY Modified Erikson Flanker Task (visual scanning) iii. SWAY Simple Reaction Time (visual simple RT) iv. SWAY Impulse Control (visual go/no-go) v. SWAY Inspection Time (visual processing speed/reaction time) vi. SWAY Number Counting (visual processing speed) vii. SWAY Modified Stroop Test (executive function)	15 minutes

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Harvard Medical School (HMS and HSDM); SWAY Medical, Inc; College of Medicine Alumni Association

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: validity; reliability; normative data; balance assessments; functional assessments; cognitive assessments
• Other Study ID Numbers: OU IRB 14031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes