Clinical trial NCT04098107: Throwing Device Tracker for Youth Injury Prevention
Official title: A Low-Cost, Collaborative Tool for the Tracking of Youth Activities to Reduce Risk of Physical Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overuse Injury
Keywords: Healthy subjects
Athletes
Baseball
Sports research
overuse injuries
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-09-23
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

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).

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.

Primary outcomes:
measure: Accuracy of the Pitching Detection Algorithm
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Elliott Greenberg, PT,DPT,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: J. Todd Lawrence, MD, PhD
role: STUDY_DIRECTOR
References: