- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03252444
Therapeutic Approaches for Subjects With Scapula Dyskinesis
June 24, 2019 updated by: National Taiwan University Hospital
Therapeutic Approaches for Subjects With Scapula Dyskinesis: Conscious Control, EMG Biofeedback Training, and Intensive Scapula-focused Intervention
The investigators will test whether conscious control with manual guides and video or EMG biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with different type of scapula dyskinesis.
The investigators will also examine how correction of scapular orientation may affect the activation of associated muscles during various dynamic movements in these subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
139
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- At least three positive of five tests, including Neer's test, Hawkin's test, Empty can test, tenderness in tendon of rotator cuff and resisted external test.
- Each patient will need a prescription of the physician or orthopedic surgeon for diagnosing impingement symptoms
Exclusion criteria:
- Shoulder pain onset due to trauma, a history of shoulder fractures or dislocation, cervical radiculopathy, degenerative joint disease of the shoulder, surgical interventions on the shoulder, or inflammatory arthropathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Biofeedback group
After 1 minute of rest, participants will perform 6 trials of bilateral, active, weighted arm elevation in the scapular plane and a therapist classifies the scapular motion into specific patterns of scapular dyskinesis.
After the evaluation of scapular dyskinesis, the kinematics and surface EMG (sEMG) data will be collected during 5 trials of the same arm movements and 3 selected exercises.
|
In electromyography (EMG) biofeedback training, electronic equipment is used to reveal instantaneously certain physiological events.
|
|
ACTIVE_COMPARATOR: Conscious control group
Conscious correction of scapular orientation will be taught to the subjects in the manner described in previous studies.
The starting position is determined in each individual by actively positioning the scapula between maximal upward and downward rotation, external and internal rotation, and posterior and anterior tilt.
Scapular assistance test (SAT) is also conducted by passively assisting patients' scapula into appropriate position to correct scapula dyskinesis
|
Conscious control of the scapula is important and can correct neuromuscular coordination as well as strength deficits.
The strategy in learning control of scapula into normal orientation can be facilitated by manual guides and/or external cues
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder complex kinematics
Time Frame: The scapular kinematics will be measured before scapular control and immediately after scapular control
|
Scapular orientation relative to the thorax is described using a Euler angle sequence of rotation about Zs (protraction/retraction), rotation about Y's (downward /upward rotation), and rotation about X"s (posterior/anterior tipping).
Scapular elevation is defined as the vertical displacement of the scapular sensor during arm elevation.
Humeral orientation relative to the scapula is described using a Euler angle sequence in which the first rotation represents the plane of elevation, the second rotation defines the amount of elevation, and the third rotation describes the amount of axial rotation.
|
The scapular kinematics will be measured before scapular control and immediately after scapular control
|
|
Shoulder associated muscular activities
Time Frame: The muscle activation will be measured before scapular control and immediately after scapular control
|
Full bandwidth sEMG data, captured by data acquisition software (AcqKnowledge, Biopac systems Inc., CA, USA)
|
The muscle activation will be measured before scapular control and immediately after scapular control
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forward shoulder posture
Time Frame: After subjects are included in the study, the forward shoulder posture will be measured before scapular control, and be done within 2 hours.
|
The measurement of the distance between the posterior border of the acromion and the table
|
After subjects are included in the study, the forward shoulder posture will be measured before scapular control, and be done within 2 hours.
|
|
Pectoralis minor muscle length
Time Frame: After subjects are included in the study, the muscle length will be measured before scapular control, and be done within 2 hours.
|
The distance from the fourth rib to the coracoids process will be measured with FASTRAK system with accuracy of 0.08 cm.
This distance (in centimeter) is divided by the subjects height and multiplied by 100.
This results in a pectoralis muscle length index
|
After subjects are included in the study, the muscle length will be measured before scapular control, and be done within 2 hours.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jiu- Jenq Lin, PhD, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 25, 2015
Primary Completion (ACTUAL)
May 21, 2017
Study Completion (ACTUAL)
May 21, 2017
Study Registration Dates
First Submitted
August 9, 2017
First Submitted That Met QC Criteria
August 14, 2017
First Posted (ACTUAL)
August 17, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 25, 2019
Last Update Submitted That Met QC Criteria
June 24, 2019
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201412043RINA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Shoulder Impingement
-
CHU de ReimsTerminatedSubacromial Impingement of the ShoulderFrance
-
Faculdade de Ciências Médicas da Santa Casa de...Completed
-
Cairo UniversityCompletedSubacromial Impingement Syndrome | Shoulder Bursitis | Pilates ExerciseEgypt
-
Emre DANSUKCompletedShoulder Pain | Impingement Shoulder | Impingement SyndromeTurkey (Türkiye)
-
Copenhagen University Hospital, HvidovreUniversity of Copenhagen; Aalborg University; Metropolitan University CollegeCompletedSubacromial Impingement SyndromeDenmark
-
China Medical University HospitalNot yet recruiting
-
Cairo UniversityNot yet recruitingShoulder ImpingementEgypt
-
Uskudar UniversityCompletedShoulder ImpingementTurkey
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Texas Tech University Health Sciences CenterCompletedThe Pull Test To Determine Responders To Subacromial Injection In Patients With Shoulder ImpingementShoulder Impingement SyndromeUnited States
Clinical Trials on Conscious control+biofeedback
-
Beijing 302 HospitalRecruitingEndoscopic Retrograde Cholangiopancreatography | Procedural Pain | Sedation-related Complications | Conscious Sedation Adverse EventChina
-
Beijing Anzhen HospitalNot yet recruitingAtrial Fibrillation (Paroxysmal)China
-
Karamanoğlu Mehmetbey UniversityCompletedVolleyball Players | Biofeedback Training | Psychological Aspects | Skin Temperature Change | Autonomic RegulationTurkey
-
Cambridge University Hospitals NHS Foundation TrustUnknownStroke | Osteoarthritis | Back Pain | Sciatica | Fibromyalgia | Complex Regional Pain Syndromes | Traumatic Brain InjuryUnited Kingdom
-
Rutgers, The State University of New JerseyNational Institute on Drug Abuse (NIDA)Completed
-
Seoul National University HospitalRecruitingSleep QualityKorea, Republic of
-
Case Western Reserve UniversityCompletedCarer Stress Syndrome | Stress | Dementia | Alzheimer's Disease | BereavementUnited States
-
Cairo UniversityCompleted
-
Sidney Kimmel Comprehensive Cancer Center at Johns...TerminatedPancreas CancerUnited States
-
Emory UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedStroke | Gait, HemiplegicUnited States