SWAY Mobile Application Assessments in Healthy Adults

Sponsor
University of Oklahoma (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05616975
Collaborator
SWAY Medical, Inc (Other), College of Medicine Alumni Association (Other), Harvard Medical School (HMS and HSDM) (Other)
700
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
700 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Reliability, Validity, Normative Data, and Accuracy of SWAY Mobile Application Assessments in Healthy Adults
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Balance Assessments [<15 minutes]

    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

  2. Functional Assessments [<15 minutes]

    i. SWAY 30 Second Chair Stand Test (functional)

  3. Cognitive Assessments [15 minutes]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT05616975
Other Study ID Numbers:
  • OU IRB 14031
First Posted:
Nov 15, 2022
Last Update Posted:
Nov 15, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by University of Oklahoma

Study Results

No Results Posted as of Nov 15, 2022