Throwing Device Trial

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.

Study Overview

• Status: Completed
• Conditions: Overuse Injury
• Intervention / Treatment: Device: Throwing Device

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Throwing Device Phase 1; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Elliott Greenberg, PT,DPT,PhD, Children's Hospital of Philadelphia; Study Director: J. Todd Lawrence, MD, PhD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Healthy subjects; Athletes; overuse injuries; Baseball; Sports research
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains; Cumulative Trauma Disorders
• Other Study ID Numbers: 19-016149; 1R43HD098958-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes