ReliabilityNCT05616975
SWAY Mobile Application Assessments in Healthy Adults
An observational study of Reliability and Validity, run by University of Oklahoma.
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. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Reliability, Validity, Normative Data
- What is being tested?
- test-retest reliability, construct validity and normative data
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 27 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Reliability, Validity, Normative Data
- Being tested
- test-retest reliability, construct validity, normative data
- Keywords
- reliability, validity, normative data, balance assessments, functional assessments, cognitive assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test-retest reliabilityOther
Assessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests.
construct validityOther
Investigating the construct validity of SWAY Balance, Functional, and Cognitive tests.
normative dataOther
Collection of normative SWAY Balance, Functional, and Cognitive data.
| Study group | Role | What they receive |
|---|---|---|
| reliability | Assessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests Receives: Other: test-retest reliability | |
| validity | Investigating the construct validity of SWAY Balance, Functional, and Cognitive tests Receives: Other: construct validity | |
| normative | Collection of normative SWAY Balance, Functional, and Cognitive data Receives: Other: normative data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Assessments
- 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
Measured: <15 minutes
Functional Assessments
- SWAY 30 Second Chair Stand Test (functional)
Measured: <15 minutes
Cognitive Assessments
- 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)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Jan 2023
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Why it stopped: This project never entered the recruitment phase due to issues with hiring study personnel.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReliabilityStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- SWAY Medical, Inc, College of Medicine Alumni Association, Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616975
- Sponsor's protocol ID
- OU IRB 14031
- Status last verified
- Mar 2024
- First submitted
- 7 Nov 2022
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability, Validity, Normative Data, and Accuracy of SWAY Mobile Application Assessments in Healthy Adults
- ClinicalTrials.gov ID
- NCT05616975
- Acronym / sponsor ID
- OU IRB 14031
- Conditions
- Reliability, Validity, Normative Data
- Keywords
- reliability, validity, normative data, balance assessments, functional assessments, cognitive assessments
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This project never entered the recruitment phase due to issues with hiring study personnel.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- SWAY Medical, Inc, College of Medicine Alumni Association, Harvard Medical School (HMS and HSDM)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| reliability | – | Other: test-retest reliabilityAssessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests |
| validity | – | Other: construct validityInvestigating the construct validity of SWAY Balance, Functional, and Cognitive tests |
| normative | – | Other: normative dataCollection of normative SWAY Balance, Functional, and Cognitive data |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| test-retest reliabilityAssessing the test-retest reliability of SWAY Balance, Functional, and Cognitive tests. | Other | reliability |
| construct validityInvestigating the construct validity of SWAY Balance, Functional, and Cognitive tests. | Other | validity |
| normative dataCollection of normative SWAY Balance, Functional, and Cognitive data. | Other | normative |
Primary outcome
Balance Assessments
Time frame: <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
Functional Assessments
Time frame: <15 minutes
i. SWAY 30 Second Chair Stand Test (functional)
Cognitive Assessments
Time frame: 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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Reliability and Validity, run by University of Oklahoma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Assessments (time frame: <15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.