Throwing Device Tracker for Youth Injury Prevention

NCT ID: NCT04098107

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2022-06-30

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).

Conditions

Overuse Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Throwing Device

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elliott Greenberg, PT,DPT,PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

J. Todd Lawrence, MD, PhD

Role: STUDY_DIRECTOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R43HD098958-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-016149

Identifier Type: -

Identifier Source: org_study_id