HealthyNCT01687023
A Wearable System to Monitor Tai Chi Practice
An observational study of Healthy, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The goal of this research study is to show that features derived from data gathered using SHIMMER wearable sensor platform can capture adherence and proficiency in the performance of exercises that are part of Tai Chi interventions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Tai Chi practitioners in a wide range of proficiency
Who may be able to join
- Young style Tai Chi practitioners
Who cannot join
- Any movement impairment that will impede Tai Chi movements performance
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, 02129
About this study
The goal of this research study is to show that features derived from data gathered using SHIMMER wearable sensor platform can capture adherence and proficiency in the performance of exercises that are part of Tai Chi interventions.
- Conditions
- Healthy
- Keywords
- Tai Chi, Wearable sensors, Movement
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 |
|---|---|---|
| Tai Chi | Healthy Tai Chi practitioners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of adherence and proficiency
Data gathered using SHIMMER devices will be segmented to derive signal features. These features will be then used to feed a pattern recognition algorithm the output of which indicates whether a specific Tai Chi movement of interest has been performed.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startJul 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687023
- Sponsor's protocol ID
- 2011-P-001597
- Status last verified
- Oct 2018
- First submitted
- 13 Sep 2012
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wearable System to Monitor Tai Chi Practice
- ClinicalTrials.gov ID
- NCT01687023
- Acronym / sponsor ID
- 2011-P-001597
- Conditions
- Healthy
- Keywords
- Tai Chi, Wearable sensors, Movement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 18 Sep 2012 (estimated)
- 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.
The goal of this research study is to show that features derived from data gathered using SHIMMER wearable sensor platform can capture adherence and proficiency in the performance of exercises that are part of Tai Chi interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | – | –Healthy Tai Chi practitioners |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Tai Chi practitioners in a wide range of proficiency
Key inclusion criteria (1 listed)
- Young style Tai Chi practitioners
Key exclusion criteria (1 listed)
- Any movement impairment that will impede Tai Chi movements performance
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
Biomarkers of adherence and proficiency
Time frame: 1 day
Data gathered using SHIMMER devices will be segmented to derive signal features. These features will be then used to feed a pattern recognition algorithm the output of which indicates whether a specific Tai Chi movement of interest has been performed.
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 18 Oct 2018.
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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.
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 Healthy, run by Spaulding Rehabilitation Hospital 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 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 18 Oct 2018. 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?
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?
Biomarkers of adherence and proficiency (time frame: 1 day). 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 18 Oct 2018.