SWAY Mobile Application Assessments in Healthy Adults

Reliability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05616975
• Other study ID #: OU IRB 14031
• Status: Withdrawn
• Start date: January 1, 2023
• Est. completion date: April 27, 2023

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Reliability
• Validity

Intervention

Other:
• test-retest reliability
Assessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests.
• construct validity
Investigating the construct validity of SWAY Balance, Functional, and Cognitive tests.
• normative data
Collection of normative SWAY Balance, Functional, and Cognitive data.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Oklahoma	College of Medicine Alumni Association, Harvard Medical School (HMS and HSDM), SWAY Medical, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Functional Assessments	i. SWAY 30 Second Chair Stand Test (functional)	<15 minutes
Primary	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