Motor ActivityNCT03120039
Measuring Upper Extremity Functional Movement with Accelerometry: FitBit® Vs Actigraph®
An observational study of Motor Activity, run by Rowe, Veronica, M.D..
Trial summary
To determine the criterion validity of the FitBit® Flex™ compared to the ActiGraph's Bluetooth® Smart wGT3X-BT wireless activity monitor, and contribute to the clinical utility of accelerometry measurement of UE movement. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 1 May 2016
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- Healthy adults with no upper extremity limitations
Who cannot join
- Upper extremity limitations
About this study
Official title: Measuring Upper Extremity Functional Movement with Accelerometry: FitBit Vs Actigraph
To determine the criterion validity of the FitBit® Flex™ compared to the ActiGraph's Bluetooth® Smart wGT3X-BT wireless activity monitor, and contribute to the clinical utility of accelerometry measurement of UE movement.
Read the detailed description
Participants will wear two different accelerometers (FitBit and Actigraph) to record normal, everyday movement. Data from each accelerometer will be compared to determine similarity.
- Conditions
- Motor Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy adults without any limitations in upper extremity movement or function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps
Number of steps
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 May 2015
- Primary completion1 May 2016
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowe, Veronica, M.D.
- Responsible party
- Principal investigator, Veronica Rowe, Rowe, Veronica, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120039
- Sponsor's protocol ID
- FitBit vs Actigraph
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Upper Extremity Functional Movement with Accelerometry: FitBit Vs Actigraph
- ClinicalTrials.gov ID
- NCT03120039
- Acronym / sponsor ID
- FitBit vs Actigraph
- Conditions
- Motor Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Rowe, Veronica, M.D.
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 19 Apr 2017 (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 determine the criterion validity of the FitBit® Flex™ compared to the ActiGraph's Bluetooth® Smart wGT3X-BT wireless activity monitor, and contribute to the clinical utility of accelerometry measurement of UE movement.
Detailed description
Participants will wear two different accelerometers (FitBit and Actigraph) to record normal, everyday movement. Data from each accelerometer will be compared to determine similarity.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | –Healthy adults without any limitations in upper extremity movement or function. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (1 listed)
- Healthy adults with no upper extremity limitations
Key exclusion criteria (1 listed)
- Upper extremity limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Steps
Time frame: 24 hours
Number of steps
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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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 Motor Activity, run by Rowe, Veronica, M.D..
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Nov 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Steps (time frame: 24 hours). 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 14 Nov 2024.