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Glenohumeral Rotation After Throwing: RCT Comparing the Sleeper Stretch to the 90/90 Hip Lift With Balloon Blow Exercise

Primary Purpose

Internal Rotation Contracture-shoulder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleeper Stretch
90/90 Hip Lift with Balloon Blow Exercise
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Internal Rotation Contracture-shoulder focused on measuring Throwing, Sleeper Stretch, Balloon Blow, GIRD (Glenohumeral internal rotation deficit)

Eligibility Criteria

15 Years - 19 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sleeper Stretch THEN Balloon Blow

Balloon Blow THEN Sleeper Stretch

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change In Shoulder Internal Rotation Range of Motion
Goniometric measurement of passive shoulder internal rotation

Secondary Outcome Measures

Full Information

First Posted
March 21, 2017
Last Updated
May 7, 2018
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03091530
Brief Title
Glenohumeral Rotation After Throwing: RCT Comparing the Sleeper Stretch to the 90/90 Hip Lift With Balloon Blow Exercise
Official Title
Restoration of Glenohumeral Internal Rotation Deficit (GIRD) After Throwing: A Randomized Clinical Trail Comparing the Sleeper Stretch to the 90/90 Hip Lift With Balloon Blow Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 14, 2018 (Actual)
Study Completion Date
April 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Purpose of the Study: 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. Specific Aim: To determine if the glenohumeral internal rotation deficit (GIRD) is more effectively restored following a throwing session by performing the sleeper stretch (SS) or the 90/90 hip lift with balloon blow exercise (BBE). Hypothesis: BBE will improve GIRD more effectively and quickly than the SS. This is a prospective randomized trial comparing the efficacy of two exercises designed to improve shoulder internal rotation. Subjects meeting study criteria will be randomly allocated to each group as shown in the following CONSORT allocation diagram. Randomization will be performed via random number generator. Each subject will participate in two week-long interventions with at least one week separating the two intervention weeks. During the week of intervention, the subject will have his baseline IR measured. He will then be instructed in how to perform a single exercise designed to improve internal rotation range of motion. Approximately half of the subjects will perform the Sleeper Stretch the first week, then the Balloon Blow Exercise the second week. The remaining group of subjects will perform the Balloon Blow Exercise during the first week, then the Sleeper Stretch the second week. Both exercises will be instructed by a physical therapist who commonly prescribes the exercises in the clinical setting. A written handout detailing the exercise instructions, frequency, and duration of the stretch will be provided for the subjects' reference (submitted with IRB application). The subject will perform this exercise throughout the week as directed by study personnel. Baseline measures of glenohumeral internal rotation (IR) with the shoulder positioned at 90 degrees of abduction in the scapular plane will be obtained using a goniometer, as described by Manske. These measurements will be repeated after the initiation of the intervention exercise at the following intervals: 2 hours, 1 day, 2 days, 3 days and 4 days. All measures of IR will be taken 3 times and the average of the three measures used in data analysis. The investigator performing the measures will be blinded to participant group assignment. When the subject completes both intervention weeks, he will be asked if he had a personal preference for either exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internal Rotation Contracture-shoulder
Keywords
Throwing, Sleeper Stretch, Balloon Blow, GIRD (Glenohumeral internal rotation deficit)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleeper Stretch THEN Balloon Blow
Arm Type
Experimental
Arm Description
Sleeper Stretch CROSSOVER TO 90/90 Hip Lift with Balloon Blow Exercise
Arm Title
Balloon Blow THEN Sleeper Stretch
Arm Type
Experimental
Arm Description
90/90 Hip Lift with Balloon Blow Exercise CROSSOVER TO Sleeper Stretch
Intervention Type
Other
Intervention Name(s)
Sleeper Stretch
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
90/90 Hip Lift with Balloon Blow Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change In Shoulder Internal Rotation Range of Motion
Description
Goniometric measurement of passive shoulder internal rotation
Time Frame
baseline, 2 hours, 1 day, 2 days, 3 days, 4 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Active participation in competitive high school baseball at the time of study participation. Ability to read, write, and speak the English language. Exclusion Criteria: 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
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Glenohumeral Rotation After Throwing: RCT Comparing the Sleeper Stretch to the 90/90 Hip Lift With Balloon Blow Exercise

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