- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02670174
Influence of Kinetic Chain Training on the Treatment Outcome of Overhead Athletes With Impingement
Influence of Kinetic Chain Training on the Treatment Outcome of Overhead Athletes With Shoulder Impingement Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participant are randomly assigned in 3 home exercise groups.
- The traditional program: consists of solely strengthening the rotator cuff muscles and scapular muscles (e.g. external rotation)
- Separate kinetic chain program: same exercises as the first group but they also receive an exercise program to separately train the core and lower body. (e.g. external rotation separately and squat separately)
- Integrated kinetic chain program: same exercises as the first group but all exercises are performed while simultaneously activating the kinetic chain. (e.g. external rotation while squatting).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
- Vakgroep REVAKI (Ghent University - Ghent University Hospital)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Symptoms of shoulder impingement on the dominant side for at least 3 months and at least 3 of the following tests are considered positive
- Jobe
- Hawkins
- Neer
- Painful arc during elevation
- Pain or lack of force production with isometric external rotation
- Apprehension test
- Relocation test
- Performing overhead sports at least 3 hours/week
- Shoulder pain interferes with sports activities
- They have not had treatment for this shoulder pain
Exclusion Criteria:
- History of shoulder dislocation or subluxation
- History of orthopedic surgery
- No complaints of pain or dysfunction in the upper limb (except impingement related complaints in the dominant shoulder), lower limb or spine at the last 6 months
- Currently taking nonsteroidal anti-inflammatory medication
- Received a steroid injection in the past 12 months
- Participating in another study
- Known systemic diseases
- Known structural diseases
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 |
---|---|
Active Comparator: Traditional training
A home exercise program consisting of rotator cuff and scapular muscle training will be performed during 6 weeks (4 sessions/week).
To monitor progress and control load progression, a physical therapist will visit the subject every week.
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Experimental: Separate kinetic chain training
A home exercise program consisting of traditional training exercises as well as separate exercises focusing on core and lower limb training will be performed during 6 weeks (4 sessions/week).
To monitor progress and control load progression, a physical therapist will visit the subject every week.
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Experimental: Integrated kinetic chain training
A home exercise program consisting of traditional training exercises while integrating core and lower limb training will be performed during 6 weeks (4 sessions/week).
To monitor progress and control load progression, a physical therapist will visit the subject every week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Shoulder Pain And Disability Index (SPADI) score
Time Frame: At baseline and within one week after the 6-weeks training program
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Patients will fill in the SPADI questionnaire to evaluate shoulder pain and function.
The SPADI is a valid, reliable and frequently used questionnaire for shoulder pain patients consisting of 13 items divided in 2 subscales: pain (5 items) and disability (8 items).
Each item was scored on a 10-point numeric rating scale.
Total and subscale scores were summed and transformed to a score out of 100 (%) were a higher score indicates a higher level of pain and/or disability
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At baseline and within one week after the 6-weeks training program
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Changes in Western Ontario Shoulder Stability index (WOSI) score
Time Frame: At baseline and within one week after the 6-weeks training program
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The WOSI is a patient-evaluated disease-specific quality of life scoring questionnaire that has been developed for shoulder instability patients.
This 21-item questionnaire consists of 4 subscales: physical symptoms (10 items), sport/recreation/work (4 items), lifestyle (4 items), and emotions (3 items).
Each item was scored on a 100-mm visual analogue scale.
Total and subscale scores were summed and transformed to a score out of 100 (%) where a higher score indicates more limitations in shoulder related quality of life
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At baseline and within one week after the 6-weeks training program
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Subjective perception of shoulder improvement
Time Frame: 6-weeks training program
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A Global Rating of Change (GROC) scale was used to quantify patient-perceived improvement of overall shoulder function after 6 weeks treatment as "improved", "unchanged" or "worse". In case they improved or got worse, the amount of change was reflected on a 5-point scale: very little change, little change, some change, a large change, a very large change. An "unchanged" condition scored 0, "improved" between 1 and 5, and "worse" between -1 and -5 points. amount of change was scored on a 5-point scale (very little change, little change, some change, a large change, a very large change) |
6-weeks training program
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in shoulder muscle isokinetic strength (Biodex system 4)
Time Frame: at baseline and within one week after the 6-weeks training program
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Isokinetic strength of shoulder internal and external rotators will be measured bilateral with the Biodex device (Biodex system 4, Biodex Medical Systems, Inc., Shirley, New York, USA).
For further analysis, concentric peak torque (PT) (rotation) or peak force (PF) (protraction-retraction) values were normalized to body weight (BW).
A higher value represents more strength and thus a better outcome.
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at baseline and within one week after the 6-weeks training program
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Changes in shoulder scapular isokinetic strength
Time Frame: at baseline and within one week after the 6-weeks training program
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Isokinetic strength of scapular protraction and retraction muscles will be measured bilateral with the Biodex device (Biodex system 4, Biodex Medical Systems, Inc., Shirley, New York, USA).
For further analysis, concentric peak torque (PT) (rotation) or peak force (PF) (protraction-retraction) values were normalized to body weight (BW).
A higher value represents more strength and thus a better outcome.
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at baseline and within one week after the 6-weeks training program
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Changes in scapular dyskinesis
Time Frame: at baseline and within one week after the 6-weeks training program
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Scapular dyskinesis will be measured by observing the scapular movement during active elevation.
For both sides (left and right), scapular dyskinesis was evaluated as being present or not.
In case dyskinesis was present, the amount of dyskinesis is scored as subtle or prominent.
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at baseline and within one week after the 6-weeks training program
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Changes in functional tests for the upper limb measured with the Y Balance Test
Time Frame: at baseline and within one week after the 6-weeks training program
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The YBT-UQ is a commonly used upper extremity functional test to assess closed kinetic chain function of the stance arm while performing an open kinetic chain movement in the reaching arm.
Under standardized verbal encouragement, patients stand in a three point plank position while using the free arm to push a reach indicator box as far as possible in 3 reach directions i.e. medial, inferolateral and superolateral.The average of the 3 test trials for each limb and each direction was normalized for upper limb length.
Additionally, a normalized composite score per side was calculated by averaging the mean normalized test scores in the 3 reach directions.
A higher scores indicates a better outcome.
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at baseline and within one week after the 6-weeks training program
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Return To Play (RTP)
Time Frame: up to one week after the 6-weeks training program
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Is it possible to return to play after 6 weeks intervention or not?
In addition, following question was asked: on a scale of 0 to 100%, what is the extent to which the injured shoulder has reached the shoulder function before the injury occurred?
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up to one week after the 6-weeks training program
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Changes in functional tests for the upper limb measured with the Seated Medicine Ball Throw
Time Frame: at baseline and within one week after the 6-weeks training program
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The SMBT is an open kinetic chain functional screening test to assess bilateral upper body power and strength.
The subjects were instructed to sit on the floor with the head, shoulder and back against the wall while holding a 2kg medicine ball with both arms.Participants had to throw the medicine ball forward, in a straight line and as far as possible with head, shoulders and back maintaining full wall contact.
For further analysis, the mean distance of 4 test trials was calculated.
A higher scores indicates a better outcome.
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at baseline and within one week after the 6-weeks training program
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ann Cools, PT, PhD, University Ghent
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- 2015/0816
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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Clinical Trials on Shoulder Impingement Syndrome
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Mahidol UniversityCompletedSubacromial Impingement Syndrome | Shoulder Impingement Syndrome | Subacromial Pain Syndrome | Subacromial Impingement | Impingement Syndrome, ShoulderIndonesia
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King Saud UniversityUnknownImpingement Syndrome, ShoulderSaudi Arabia
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Linkoeping UniversityCompletedSubacromial Impingement SyndromeSweden
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Sacred Heart UniversityNova Southeastern UniversityCompletedSubacromial Impingement Syndrome | Subacromial Impingement
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