Clinical trial NCT05616975: SWAY Mobile Application Assessments in Healthy Adults
Official title: Reliability, Validity, Normative Data, and Accuracy of SWAY Mobile Application Assessments in Healthy Adults
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Reliability
Validity
Normative Data
Keywords: reliability
validity
normative data
balance assessments
functional assessments
cognitive assessments
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: SWAY Medical, Inc
name: College of Medicine Alumni Association
name: Harvard Medical School (HMS and HSDM)
First posted: 2022-11-15
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Balance Assessments
timeFrame: <15 minutes
measure: Functional Assessments
timeFrame: <15 minutes
measure: Cognitive Assessments
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: