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Throwing Device Tracker for Youth Injury Prevention

A Low-Cost, Collaborative Tool for the Tracking of Youth Activities to Reduce Risk of Physical Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04098107
Enrollment
10
Registered
2019-09-23
Start date
2019-06-10
Completion date
2022-06-30
Last updated
2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overuse Injury

Keywords

Healthy subjects, Athletes, Baseball, Sports research, overuse injuries

Brief 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. 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).

Interventions

DEVICEThrowing Device

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).

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

Pilot Phase: 1. Males or females age 8 to 14 years 2. 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: 1. Males or females age 8 to 14 years 2. Involved in official baseball team and primarily plays as the pitcher

Exclusion criteria

Pilot Phase 1. Injury of any aspect of the throwing arm 2. Unwillingness to perform all requested motions 3. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study procedures. Phase 1 1. Injury or disability impeding ability to perform normal baseball-related movements 2. Inability/unwillingness to schedule and/or travel to the Human Motion Laboratory 3. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the Pitching Detection Algorithm12 monthsThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Throwing Device Phase 1
Subjects were asked to wear the prototype device during a simulated baseball game (approximately 30-45 pitches), and then perform a set of other baseball-specific movements while fitted with infrared markers for throwing analysis. This information to help us develop a small wearable device that collects and tracks information (such as force) about throwing movements during youth athletic activity to identify and track arm fatigue
10
Total10

Baseline characteristics

CharacteristicThrowing Device Phase 1
Age, Categorical
<=18 years
10 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous11.3 years
STANDARD_DEVIATION 1.1
Race/Ethnicity, Customized
Race - White
10 Participants
Region of Enrollment
United States
10 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

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.

Time frame: 12 months

Population: Our criteria for success was the accuracy of pitching event detection, which was 98.6%

ArmMeasureValue (NUMBER)
Throwing Device Phase 1Accuracy of the Pitching Detection Algorithm98.6 percentage

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026