- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05857540
The Effects of Upper-Extremity Plyometric Combined Strength Training in Overhead Athletes With Shoulder Instability
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: Shoulder instability is a common problem in active young adults with a wide spectrum ranging from microinstability, subluxation to dislocation. In patients with instability of Stanmore polar type 2 or 3, recurrent shoulder instability may be related to abnormal movement patterns but not result from trauma. Non-operative management is suggested to this subgroup as the first-line treatment. Previous rehabilitation protocols including progressive shoulder muscles strengthening and neuromuscular control training have shown positive effects on functional outcomes in individuals with shoulder instability. Recent protocols for shoulder instability usually include various types of plyometric training to prepare injured athletes to return to sports. Plyometric training in lower extremity has been wildly used for knee injury prevention. In upper extremity, plyometrics also has been shown to improve isokinetic strength, throwing performance, and proprioception in healthy subjects and healthy overhead athletes. However, it is still not well-understood that whether a strengthening training combined with plyometrics would be more effective to improve shoulder neuromuscular control and shoulder function in subjects with instability. The purpose of this study is to investigate the additional effects of upper extremity plyometric training in recreational overhead athletes with anterior shoulder instability. The investigators hypothesis that compared to strengthening training alone, plyometric training combined with strengthening training will significantly improve strength, proprioception, shoulder kinematic and muscle activity, shoulder pain and shoulder function.
Methods: A total of 64 participants with anterior shoulder instability will be randomized to either an experimental group (plyometric and strengthening training) or a control group (strengthening training). Both groups will receive a 50-minute supervised training protocol twice a week for 6 weeks. The primary outcomes include (1) isokinetic assessment of internal and external rotation (peak torque, time to peak torque, and amortization time); (2) proprioception (active and passive joint position sense); (3) seated medicine ball throw test (distance in cm). The secondary outcomes include (1) shoulder pain and instability with 10-cm visual analogue scale (VAS); (2) shoulder function assessed with the Disability of Arm, Shoulder and Hand (DASH) questionnaire; (3) Global rating of change (GRC). GRC will be measured after the end of 12 session of intervention, and all the other outcomes will be measured at baseline and following 12 sessions of exercise training. The two-way repeated measures ANOVAs will be used to compare primary and secondary outcome variables between groups. The significant level was set at 0.05.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yin-Liang Lin, PhD
- Phone Number: +886-2-2826-7288
- Email: yllin1020@nycu.edu.tw
Study Contact Backup
- Name: Tzu-Hsuan Huang, BS
- Phone Number: +886-910775771
- Email: tzuhsuan1997@gmail.com
Study Locations
-
-
台北市
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Taipei, 台北市, Taiwan, 112
- Recruiting
- National Yang Ming Chiao Tung University
-
Contact:
- YIN-LIANG LIN
- Phone Number: +886-2-28267288
- Email: yllin1020@nycu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have experience of at least 1 of the following symptoms of shoulder instability during upper extremity movement: (a) pain, clicking, a sense of the shoulder coming apart, (b) dead-arm syndrome, or (c) subluxation of the joint.
- Self-reported decreased performance or feeling fear to perform shoulder movements during sports or daily activities
- Positive findings on ≥ 1 of the following 5 tests: load and shift test, apprehension, relocation, & surprise tests, Gagey hyperabduction test, sulcus sign, Feagin test
- Recreational overhead athletes who keep practicing ≥ 4 hours/week in the recent 1 month and with ≥ 1 year overhead sports experience
Exclusion Criteria:
- Full contact sport athletes
- Severe shoulder instability with > 5 shoulder dislocations history
- Obvious shoulder bony/labrum lesion in the dominant side warranted for surgery first as decided by the orthopedic surgeon
- Previous surgery or fracture in the shoulder area on the dominant side within 1 year
- Voluntary instability (the ability to deliberately dislocate one's shoulder)
- During acute phase after shoulder dislocation event
- Not suitable to start plyometric training yet: Shoulder muscle weakness (manual muscle test <3) or range of motion limitation (<90 abduction, <70 external rotation) in the dominant side
- Pregnancy
- Cancer, neck pain, brain & neurological impairment
- Ehlers-Danlos syndrome or Marfan syndrome
- Unable to attend 6 weeks supervised training
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: Plyometric training group
Participants in this group will receive upper extremity plyometric training in body weight or with weight ball and strengthening exercises with band, dumbbell and barbell.
The difficulty and intensity of the movement protocol will increase weekly.
They will be trained 2 times per week for 6 weeks with an average duration of 50 min per session.
|
Each session includes 2 upper-extremity plyometric exercises in bodyweight or with weight ball for 15-20 minutes and 4-5 strengthening exercises with band, dumbbell or barbell for 30-35 minutes.
The difficulty of the movement protocol will increase weekly.
They will be trained 2 times per week for 6 weeks with an average duration of 50 min per session.
|
Active Comparator: Strengthening training group
Participants in this group will receive upper extremity strengthening exercises with band, dumbbell and barbell.
The intensity of the movement protocol will increase weekly.
They will be trained 2 times per week for 6 weeks with an average duration of 50 min per session.
|
Each session includes 5 upper-extremity strengthening exercises with band, dumbbell or barbell for 50 minutes.
The difficulty of the movement protocol will increase weekly.
They will be trained 2 times per week for 6 weeks with an average duration of 50 min per session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder isokinetic muscle strength
Time Frame: Change from baseline shoulder isokinetic muscle strength through completion of 12-session intervention, an average of 6 weeks
|
Shoulder isokinetic muscle strength will be measured by dynamometer in 3 modes (concentric/concentric, concentric/eccentric, eccentric/concentric) at 3 angular velocities (90°/s, 180°/s, & 240°/s), 1 set of 5 repetitions for each angular velocities.
Shoulder isokinetic muscle strength will be normalized by body weight (BW) and described with peak torque/BW (N·m·kg-1).
|
Change from baseline shoulder isokinetic muscle strength through completion of 12-session intervention, an average of 6 weeks
|
Shoulder acceleration time, deceleration time, and amortization time
Time Frame: Change from baseline shoulder isokinetic muscle strength through completion of 12-session intervention, an average of 6 weeks
|
Shoulder acceleration time, deceleration time, and amortization time will be measured by dynamometer in concentric/concentric mode at 3 angular velocities (90°/s, 180°/s, & 240°/s) and will be described with millisecond (ms).
|
Change from baseline shoulder isokinetic muscle strength through completion of 12-session intervention, an average of 6 weeks
|
Shoulder proprioception
Time Frame: Change from baseline shoulder external rotation joint position sense through completion of 12-session intervention, an average of 6 weeks
|
Shoulder proprioception will be measured by dynamometer in 90° shoulder abduction and 90° elbow flexion position, including active joint position sense and passive joint position sense.
The proprioception will be described with degree of error from target position.
|
Change from baseline shoulder external rotation joint position sense through completion of 12-session intervention, an average of 6 weeks
|
Seated medicine ball throw distance
Time Frame: Change from baseline seated medicine ball throw distance through completion of 12-session intervention, an average of 6 weeks
|
Subjects will throw a 2kg soft weighted ball as far forward as possible with dominant arms while sitting with back against a wall and legs bending with feet flat on the floor.
Outcomes include average throwing distance and maximal throwing distance (cm).
The distances are measured with measure tape.
|
Change from baseline seated medicine ball throw distance through completion of 12-session intervention, an average of 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder function
Time Frame: Change from baseline DASH questionnaire through completion of 12-session intervention, an average of 6 weeks
|
Shoulder function will be measured by the disabilities of the arm, shoulder and hand (DASH) questionnaire, including the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5).
A higher score indicates greater disability.
|
Change from baseline DASH questionnaire through completion of 12-session intervention, an average of 6 weeks
|
Visual analogue scale (VAS) of shoulder pain and instability
Time Frame: Change from baseline VAS of shoulder pain and instability through completion of 12-session intervention, an average of 6 weeks
|
Shoulder pain and instability will be measured by visual analogue scale (VAS).
Subjects need to mark the point that they feel represent their perception of their current state on a 10-cm line.
Scores range from 0 (no symptom) to 100 (maximum symptom).
|
Change from baseline VAS of shoulder pain and instability through completion of 12-session intervention, an average of 6 weeks
|
Global rating of change (GRC)
Time Frame: through completion of 12-session intervention, an average of 6 weeks
|
The improvements in a patient's condition will be measured with 15-point self-report GRC scale.
Score ranges from -7 (lack of progress) to 7 (maximum of progress).
|
through completion of 12-session intervention, an average of 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yin-Liang Lin, PhD, National Yang Ming Chiao Tung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YM111161F
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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