Mobility LimitationNCT04854148
Validation of a Smartphone-based Assessment of Movement Health
An observational study of Mobility Limitation, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
To correlate a smartphone-based assessment of mobility, stability, and posture with those derived from standard clinical tests among a heterogeneous cohort. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Smartphone Movement Health Assessment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2021to 12 Dec 2022
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling adults
Who may be able to join
- All participants should be able to perform the Smartphone movement health assessment and receive a score for their movement health. This will be evaluated by the research team members during the recruitment process.
- Ages 18-85 years old
- Able and willing to give written consent and comply with study procedures
Who cannot join
- Pregnant or nursing
- Skin allergies or irritation that would prevent safe use of sensors described in protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Smartphone-based Assessment of Movement Health Compared to a Battery of Standardized Clinical Tests for Mobility, Stability, and Posture
To correlate a smartphone-based assessment of mobility, stability, and posture with those derived from standard clinical tests among a heterogeneous cohort.
Read the detailed description
Smartphone movement health assessment introduces a new measure of health that helps users analyze and improve their mobility, stability and posture through performance of movements and physical exercises. To verify the accuracy of this measure, the goal is to provide data-driven evidence regarding its accuracy in comparison to gold standard tests for measuring movement health. To address this challenge, the assessment scores will be benchmarked to a set of gold standard tests and sensor metrics for measuring movement health recommended by professional associations such as the American Physical Therapy Association (APTA) or American College of Sport Medicine (ACSM) and found valid in clinical studies , .
- Conditions
- Mobility Limitation
- Being tested
- Smartphone Movement Health Assessment
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Movement Health AssessmentOther
Also called Gold Standard Movement Assessments
Participants will perform the assessment using an App installed on a smartphone device. Following the smartphone assessment, gold standard clinical assessments will be performed and scored for comparison
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Each participant will perform a Smartphone movement health assessment and a series of 12 gold standard tests under the supervision of a licensed physical therapist or other research study staff Receives: Other: Smartphone Movement Health Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation
Positive correlation between Smartphone's movement health assessment scores and the scores of standardized tests and sensors metrics for mobility, stability and posture
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start21 Apr 2021
- Primary completion12 Dec 2022 (estimated)
- Study completion12 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854148
- Sponsor's protocol ID
- STU00214468
- Status last verified
- May 2022
- First submitted
- 16 Apr 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Smartphone-based Assessment of Movement Health Compared to a Battery of Standardized Clinical Tests for Mobility, Stability, and Posture
- ClinicalTrials.gov ID
- NCT04854148
- Acronym / sponsor ID
- STU00214468
- Conditions
- Mobility Limitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 12 Dec 2022 (estimated)
- Study completion
- 12 Dec 2022 (estimated)
- First posted
- 22 Apr 2021 (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.
To correlate a smartphone-based assessment of mobility, stability, and posture with those derived from standard clinical tests among a heterogeneous cohort.
Detailed description
Smartphone movement health assessment introduces a new measure of health that helps users analyze and improve their mobility, stability and posture through performance of movements and physical exercises. To verify the accuracy of this measure, the goal is to provide data-driven evidence regarding its accuracy in comparison to gold standard tests for measuring movement health. To address this challenge, the assessment scores will be benchmarked to a set of gold standard tests and sensor metrics for measuring movement health recommended by professional associations such as the American Physical Therapy Association (APTA) or American College of Sport Medicine (ACSM) and found valid in clinical studies , .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Smartphone Movement Health AssessmentEach participant will perform a Smartphone movement health assessment and a series of 12 gold standard tests under the supervision of a licensed physical therapist or other research study staff |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling adults
Key inclusion criteria (3 listed)
- All participants should be able to perform the Smartphone movement health assessment and receive a score for their movement health. This will be evaluated by the research team members during the recruitment process.
- Ages 18-85 years old
- Able and willing to give written consent and comply with study procedures
Key exclusion criteria (2 listed)
- Pregnant or nursing
- Skin allergies or irritation that would prevent safe use of sensors described in protocol
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 |
|---|---|---|
| Smartphone Movement Health AssessmentAlso: Gold Standard Movement AssessmentsParticipants will perform the assessment using an App installed on a smartphone device. Following the smartphone assessment, gold standard clinical assessments will be performed and scored for comparison | Other | Experimental |
Primary outcome
Correlation
Time frame: Baseline
Positive correlation between Smartphone's movement health assessment scores and the scores of standardized tests and sensors metrics for mobility, stability and posture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mobility Limitation, run by Shirley Ryan AbilityLab at 1 site in United States.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Correlation (time frame: Baseline). 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 4 May 2022.