Throwing Device Tracker for Youth Injury Prevention

NCT04098107 | Completed Results FDA Device

• 2 other identifiers: 19-0161491R43HD098958-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Overuse Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (1)

Throwing Device Phase 1

EXPERIMENTAL

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

Interventions

Throwing Device 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).

Throwing Device Phase 1

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and Strains; Wounds and Injuries

Results Point of Contact

• Title: Elliot Greenberg
• Organization: Children's Hospital of Philadelphia

GREENBERGE@chop.edu

215-590-1527

Study Officials

• Elliott Greenberg, PT,DPT,PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• J. Todd Lawrence, MD, PhD

  Children's Hospital of Philadelphia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: September 23, 2019
• Study Start: June 10, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)