- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03044236
Effect of a Novel Stretching Technique on Shoulder Range of Motion and Voluntary Contraction in Overhead Athletes With Glenohumeral Internal Rotation Deficits "GIRD" (GIRD)
Effect of a Novel Stretching Technique on Shoulder Range of Motion and Maximum Voluntary Contraction in Overhead Athletes With Glenohumeral Internal Rotation Deficits: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To examine and compare the effect of a novel stretching technique and traditional stretching on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject satisfaction in overhead athletes with glenohumeral internal rotation deficits through a randomized clinical study. The investigators hypothesize that this type of novel intervention will help subjects with GIRD to restore range of motion, experience less pain and maintain the strength and motor unit recruitment following the novel intervention. This will help us to assess the potential beneficial effect of such intervention and to fill the gap in knowledge and help health care professionals to adequately select the right treatment modality.
Independent Variable
1. Type of Intervention:
- Traditional Stretching (Modified Sleep Stretch). VS
- Novel Stretching (Active Shoulder Internal Rotation while Bridging) 2. Time
Pre VS post intervention Dependent Variables
- Glenohumeral internal rotation ROM
- Maximal glenohumeral external rotation isometric strength.
- Mean motor unit recruitment (EMG) of the glenohumeral external rotator (infraspinatus) and internal rotators (pectoralis major and latissumus dorsi)
- Pain
- Subject satisfaction
Instrumentation :
- Glenohumeral internal & external rotation ROM: will be measured at baseline and at week four-post intervention for all participants. We will use the digital inclinometer. Research by (Kolber et al.,2011 ) showed this instrument to be reliable with an intra-rater ICC =0.87 and inter-rater ICC =0.93
- Electronic push/pull dynamometer: At the end feel ROM, and before ROM is measured, the therapist will apply the same amount of pressure to all subjects to ensure reliable/ valid ROM measurements.
- Maximal Glenohumeral External Rotation Isometric Strength will be measured using a MicroFET2 handheld digital dynamometer. This device was shown to be reliable with an intra-rater ICC =0.85 and inter-rater ICC =0.85.
- Maximum Voluntary Contraction: will be measured using a 44 Delsys Bagnoli portable surface electromyography (sEMG) system.
- Pain: will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS has shown to have a valid, reliable and appropriate for use in clinical practice
Procedures:
All participants will perform the static stretching (SS) conditions by themselves. The two stretching techniques will be home-based program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Loma Linda, California, United States, 92354
- Loma Linda U
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants must be between the age of 18 and 45.
- Perform overhead sports activities in the past 3 months.
- Participants are required to display ≥ 20° less glenohumeral internal rotation ROM in their dominant shoulder compare to the non- dominate shoulder.
- Participants will be included with or without pain during shoulder activities.
Exclusion Criteria:
- Will exclude participants who are still recovering from previous surgery of the shoulder and elbow complex in the past 3 months, and currently receiving medical intervention for the shoulder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Novel Stretching Technique
Participants will perform the novel stretch in a supine position.
Participants will place a small ball between their knees and squeeze the ball.
Participants will be then bridge as high as possible .
Participants will then flex their shoulder and elbow to 90°, and actively rotate to the end of ROM.
Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch.
|
The novel stretching technique will be done on a supine position.
subjects will be asked bridge as high as possible.
After That, Participants will then flex their shoulder and elbow to 90°.
Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch.
|
Active Comparator: Traditional Stretching Technique
Participants will perform the modified sleeper stretch in a side-lying position on the side of the throwing shoulder with the throwing shoulder and elbow flexed to 90° .
The participants will be instructed to allow the throwing shoulder to naturally fall into internal rotation to the end ROM where resistance will be felt .
The participants will be then instructed to use the non-throwing hand to push the throwing shoulder into further internal rotation to the point of mild discomfort by applying pressure at the area of the wrist joint.
|
The novel stretching technique will be done on a supine position.
subjects will be asked bridge as high as possible.
After That, Participants will then flex their shoulder and elbow to 90°.
Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glenohumeral internal rotation ROM
Time Frame: Change from baseline at week 4
|
The investigators will use the digital inclinometer
|
Change from baseline at week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal glenohumeral external rotation isometric strength
Time Frame: Change from baseline at week 4
|
will be measured using a MicroFET2 handheld digital dynamometer
|
Change from baseline at week 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean motor unit recruitment (EMG) of the glenohumeral external rotator (infraspinatus) and internal rotators (pectoralis major and latissumus dorsi)
Time Frame: Change from baseline at week 4
|
will be measured using surface electromyography (sEMG) system
|
Change from baseline at week 4
|
Pain will be measured using the Numeric Pain Rating Scale
Time Frame: Change from baseline at week 4
|
will be measured using the Numeric Pain Rating Scale
|
Change from baseline at week 4
|
Subject satisfaction will be measured using the Subject satisfaction Form
Time Frame: Week 4
|
will be measured using the Subject satisfaction Form
|
Week 4
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5170032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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