SWAY Mobile Application Assessments in Healthy Adults

NCT05616975 | Withdrawn FDA Device

• 1 other identifier: OU IRB 14031
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reliability; Validity; Normative Data

Keywords

reliability; validity; normative data; balance assessments; functional assessments; cognitive assessments

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

reliability

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

Other: test-retest reliability

validity

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

Other: construct validity

normative

Collection of normative SWAY Balance, Functional, and Cognitive data

Other: normative data

Interventions

test-retest reliability OTHER

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

reliability

construct validity OTHER

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

validity

normative data OTHER

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

normative

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Reproducibility of Results

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: January 1, 2023
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03