NCT03091530

Brief Summary

The primary purpose of this study is to determine if the loss of internal rotation following a throwing session is best restored through soft tissue stretching with the sleeper stretch or with scapular repositioning with the 90/90 hip lift with balloon blow exercise. This study will progress the body of research related to internal rotation deficits with regards to baseball throwers. The research will be relevant to clinicians who treat patients with baseball players with internal rotation loss. High school baseball players will be the targeted subjects for this study. They will perform two exercises (one per week) designed to increase shoulder internal rotation over the course of three weeks with one week of rest between intervention weeks. The primary outcome will be shoulder internal rotation range of motion improvements over the course of one week's time. There are no known adverse risks to either intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2018

Completed
Last Updated

May 8, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

March 21, 2017

Last Update Submit

May 7, 2018

Conditions

Keywords

ThrowingSleeper StretchBalloon BlowGIRD (Glenohumeral internal rotation deficit)

Outcome Measures

Primary Outcomes (1)

  • Change In Shoulder Internal Rotation Range of Motion

    Goniometric measurement of passive shoulder internal rotation

    baseline, 2 hours, 1 day, 2 days, 3 days, 4 days

Study Arms (2)

Sleeper Stretch THEN Balloon Blow

EXPERIMENTAL

Sleeper Stretch CROSSOVER TO 90/90 Hip Lift with Balloon Blow Exercise

Other: Sleeper StretchOther: 90/90 Hip Lift with Balloon Blow Exercise

Balloon Blow THEN Sleeper Stretch

EXPERIMENTAL

90/90 Hip Lift with Balloon Blow Exercise CROSSOVER TO Sleeper Stretch

Other: Sleeper StretchOther: 90/90 Hip Lift with Balloon Blow Exercise

Interventions

The sleeper stretch protocol will follow the process described by Wilk with the subject lying on his throwing shoulder side, with the lateral border of the scapula on the table, and the glenohumeral and elbow joints both at 90 degrees of flexion. Participants will be instructed to passively internally rotate the shoulder with gentle overpressure applied on the dorsum of the dominant arm wrist by the nondominant hand to the point of stretch on the posterior aspect of the shoulder. Stretches will be held for 20 seconds each and repeated 4 times for optimal sustained collagen elongation. This protocol will be performed on days 0-4 after the throwing session.

Balloon Blow THEN Sleeper StretchSleeper Stretch THEN Balloon Blow

The 90/90 Hip Lift with Balloon Blow Exercise (BBE) will follow the guidelines described by the Postural Restoration Institute. The subjects will lie supine with hips and knees flexed to 90 degrees, the right arm flexed to end range and resting on the floor. Using the left arm to hold the balloon, subjects will inhale fully and exhale into a balloon while holding a posterior pelvic tilt. The subjects inhale and then exhale into the balloon fully, then hold their breath for 5 seconds while putting their tongue on the roof of their mouth.

Balloon Blow THEN Sleeper StretchSleeper Stretch THEN Balloon Blow

Eligibility Criteria

Age15 Years - 19 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Active participation in competitive high school baseball at the time of study participation.
  • Ability to read, write, and speak the English language.

You may not qualify if:

  • Prior surgery to the dominant (throwing) shoulder
  • Any current upper extremity injury or limitation that restricts full participation in sport
  • Latex allergy secondary to use of latex material of the balloon
  • Any known inability to be physically present for daily testing during the weeks of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 27, 2017

Study Start

January 1, 2018

Primary Completion

April 14, 2018

Study Completion

April 14, 2018

Last Updated

May 8, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations