Throwing Device Trial

Overuse Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098107
• Other study ID #: 19-016149
• Secondary ID: 1R43HD098958-01
• Status: Completed
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Secondary objectives include evaluating the feasibility of wearing the throwing device during simulated baseball play.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cumulative Trauma Disorders
• Overuse Injury

Intervention

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).

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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