Overuse InjuryNCT04098107
Throwing Device Tracker for Youth Injury Prevention
A study testing Throwing Device in people with Overuse Injury, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The primary objective of this study is to collect motion-capture data on movements common to baseball play in order to develop an algorithm for a wearable device for the prevention and rehabilitation of sports-related overuse injuries. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Overuse Injury
- What is being tested?
- Throwing Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pilot Phase:
- Males or females age 8 to 14 years
- Presenting to the Children's Hospital of Philadelphia (CHOP) Physical Therapy Clinic for rehabilitation of injury that does not impede their ability to perform basic throwing movements.
- Phase 1:
- Males or females age 8 to 14 years
- Involved in official baseball team and primarily plays as the pitcher
Who cannot join
- Pilot Phase
- Injury of any aspect of the throwing arm
- Unwillingness to perform all requested motions
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study procedures.
- Phase 1
- Injury or disability impeding ability to perform normal baseball-related movements
- Inability/unwillingness to schedule and/or travel to the Human Motion Laboratory
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Low-Cost, Collaborative Tool for the Tracking of Youth Activities to Reduce Risk of Physical Injury
The primary objective of this study is to collect motion-capture data on movements common to baseball play in order to develop an algorithm for a wearable device for the prevention and rehabilitation of sports-related overuse injuries. Secondary objectives include evaluating the feasibility of wearing the throwing device during simulated baseball play.
Read the detailed description
With the rise in competitive sports participation in pediatric and adolescent populations, there has also been an increase in overuse injuries. Current methods of overuse injury prevention, such as pitch-counting, fail to account for differing techniques or effort and often ignore the elevated risk for children participating in two or more sports emphasizing the same body part. This wearable device seeks to more accurately monitor overuse to prevent and aid rehabilitation of overuse injuries.
Subjects will be asked to fill out a short survey about their athletic activities. They will wear a prototype of a minimal risk throwing device during simulated baseball play in a sports medicine session or at the Human Motion Laboratory. Various motion data from the device and from the Motion Lab analysis will be collected to create and refine an algorithm to quantify workload and throwing movements.
The primary endpoint of this study is to quantify motion capture data on movements common to baseball play. The secondary endpoints include quantifying injury associated with different baseball movement using the proposed system, development of algorithms to quantify workloads associated with injury during common baseball movements and validation of basic device measurements (Pilot Phase).
- Conditions
- Overuse Injury
- Being tested
- Throwing Device
- Keywords
- Healthy subjects, Athletes, Baseball, Sports research, overuse injuries
- Medical subject headings
- Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Throwing DeviceDevice
The Innovative Design Labs ( IDL) PhySens will be used to monitor the physical motions of subjects during standard sports-related actions (e.g. throwing a baseball). For this test, the PhySens Carrier will be attached via clothing rivets to a fabric sleeve or strap made of compliant materials commonly used in clothing and wearable products (e.g. nylon, spandex, neoprene).
| Study group | Role | What they receive |
|---|---|---|
| Throwing Device Phase 1 | Experimental | During Phase 1, subjects that have been recruited, consented, and enrolled will come to the biomechanics laboratory for throwing performance housed at the University of Pennsylvania (Human Motion Laboratory) on the day of their appointment. Subjects will be asked to wear the prototype device during a simulated baseball game (approximately 30-45 pitches), and then will perform a set of other baseball-specific movements while fitted with infrared markers for throwing analysis. This data will be used to develop and refine the algorithm for the prototype. Receives: Device: Throwing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the Pitching Detection Algorithm
The number of pitches thrown were tracked and counted visually during data collection. The actual pitch count was then compared to the pitch count logged by the device algorithm to determine the accuracy of the algorithm in detecting pitching events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start10 Jun 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overuse InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a wearable prototype device for monitoring upper extremity sports related forces translated to the body during activity. The system will track exposure to injurious forces and monitor adherence to sport specific overuse standards and prescribed rehab regimens.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Elliott Greenberg, PT,DPT,PhD, Principal investigator, Children's Hospital of PhiladelphiaJ. Todd Lawrence, MD, PhD, Study director, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098107
- Sponsor's protocol ID
- 19-016149
- Other IDs
- 1R43HD098958-01
- Status last verified
- May 2024
- First submitted
- 12 Aug 2019
- Last updated
- 25 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low-Cost, Collaborative Tool for the Tracking of Youth Activities to Reduce Risk of Physical Injury
- ClinicalTrials.gov ID
- NCT04098107
- Acronym / sponsor ID
- 19-016149
- Conditions
- Overuse Injury
- Keywords
- Healthy subjects, Athletes, Baseball, Sports research, overuse injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Posted 25 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to collect motion-capture data on movements common to baseball play in order to develop an algorithm for a wearable device for the prevention and rehabilitation of sports-related overuse injuries. Secondary objectives include evaluating the feasibility of wearing the throwing device during simulated baseball play.
Detailed description
With the rise in competitive sports participation in pediatric and adolescent populations, there has also been an increase in overuse injuries. Current methods of overuse injury prevention, such as pitch-counting, fail to account for differing techniques or effort and often ignore the elevated risk for children participating in two or more sports emphasizing the same body part. This wearable device seeks to more accurately monitor overuse to prevent and aid rehabilitation of overuse injuries.
Subjects will be asked to fill out a short survey about their athletic activities. They will wear a prototype of a minimal risk throwing device during simulated baseball play in a sports medicine session or at the Human Motion Laboratory. Various motion data from the device and from the Motion Lab analysis will be collected to create and refine an algorithm to quantify workload and throwing movements.
The primary endpoint of this study is to quantify motion capture data on movements common to baseball play. The secondary endpoints include quantifying injury associated with different baseball movement using the proposed system, development of algorithms to quantify workloads associated with injury during common baseball movements and validation of basic device measurements (Pilot Phase).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a wearable prototype device for monitoring upper extremity sports related forces translated to the body during activity. The system will track exposure to injurious forces and monitor adherence to sport specific overuse standards and prescribed rehab regimens.
| Arm | Type | Receives |
|---|---|---|
| Throwing Device Phase 1 | Experimental | Device: Throwing DeviceDuring Phase 1, subjects that have been recruited, consented, and enrolled will come to the biomechanics laboratory for throwing performance housed at the University of Pennsylvania (Human Motion Laboratory) on the day of their appointment. Subjects will be asked to wear the prototype device during a simulated baseball game (approximately 30-45 pitches), and then will perform a set of other baseball-specific movements while fitted with infrared markers for throwing analysis. This data will be used to develop and refine the algorithm for the prototype. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Males or females age 8 to 14 years
- Presenting to the Children's Hospital of Philadelphia (CHOP) Physical Therapy Clinic for rehabilitation of injury that does not impede their ability to perform basic throwing movements.
- Males or females age 8 to 14 years
- Involved in official baseball team and primarily plays as the pitcher
Key exclusion criteria (8 listed)
- Pilot Phase
- Injury of any aspect of the throwing arm
- Unwillingness to perform all requested motions
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study procedures.
- Phase 1
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 |
|---|---|---|
| Throwing DeviceThe Innovative Design Labs ( IDL) PhySens will be used to monitor the physical motions of subjects during standard sports-related actions (e.g. throwing a baseball). For this test, the PhySens Carrier will be attached via clothing rivets to a fabric sleeve or strap made of compliant materials commonly used in clothing and wearable products (e.g. nylon, spandex, neoprene). | Device | Throwing Device Phase 1 |
Primary outcome
Accuracy of the Pitching Detection Algorithm
Time frame: 12 months
The number of pitches thrown were tracked and counted visually during data collection. The actual pitch count was then compared to the pitch count logged by the device algorithm to determine the accuracy of the algorithm in detecting pitching events.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Elliott Greenberg, PT,DPT,PhD principal investigator
Children's Hospital of Philadelphia
J. Todd Lawrence, MD, PhD study director
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Throwing Device in people with Overuse Injury, run by Children's Hospital of Philadelphia 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 6 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: finished, as of the sponsor's last update on 25 Jun 2024. 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?
Yes. Results are posted in the registry (first posted 25 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy of the Pitching Detection Algorithm (time frame: 12 months). 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 25 Jun 2024.