Throwing Device Trial

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Overuse Injury

Intervention / Treatment
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* Device: Throwing Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Throwing Device Phase 1<br>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. | Device: Throwing Device<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of wearing the PhySens throwing device during simulated baseball play | Subjects will be asked to put on the PhySens throwing monitor device prototype at the beginning of their physical therapy session and will wear the device for the duration of the visit or until asked by a member of the study team to remove the device.The device will collect motion data for the duration of the session. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of occurrences of injury associated with simulated baseball play | Algorithms will be developed to quantify injury associated with common baseball injures from subjects wearing the prototype device and participate in a simulated game. Participants will pitch approximately 30-45 times using varying pitch types. | 12 months | 
| Motion Capture Data Quantification common to baseball play | Motion-capture data on movements common to baseball play will be captured from participants wearing the device. Participants will be fitted with 51 infrared reflective markers to enable tracking of limb, torso, and head movement while actions are performed. Movement data will be video recorded and recorded with 12 Motion Analysis Raptor IR cameras | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy subjects, Athletes, Baseball, Sports research, overuse injuries