- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04743830
Scapular Training in Stroke Individuals
March 14, 2022 updated by: ÖZGE ONURSAL KILINÇ, Hacettepe University
Effects of Scapular Training on Scapular Kinematics, Periscapular Muscle Thickness, Shoulder Subluxation and Upper Extremity Functionality in Stroke Individuals
In recent publications evaluating scapular kinematics after stroke, it is emphasized that scapular muscles, which affect the performance of upper limbs in daily life, should not be ignored.
When the literature is analyzed for these reasons, the studies in which scapular training was added to the treatment plan of upper limb rehabilitation of stroke individuals are inadequate and the existing studies have methodological deficiencies.
Also, it is seen that studies which investigate the effects of these exercises on scapular kinematics, the parameters of periscapular muscle thickness and shoulder subluxation are not included.
The purpose of this study is to examine the effects of scapular training on scapular kinematics, periscapular muscle thickness, shoulder subluxation and upper extremity functionality in stroke individuals.
The study was planned to include 2 groups, 1 treatment and 1 control group.
The control group will receive Neurodevelopmental Treatment - Bobath exercises, while the treatment group will receive exercises for the muscles around the scapula in addition to Neurodevelopmental Treatment - Bobath exercises.
Muscle thickness of periscapular muscles, shoulder subluxation, 3D scapular kinematics, upper extremity and trunk performance, pain, activities of daily living and quality of life will be assessed before and after 8 weeks treatment program.
As a result; effectiveness of scapular training in addition to Neurodevelopmental Treatment and relationship between scapular kinematics, periscapular muscle thickness, shoulder subluxation, and upper extremity performance will be examined.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
30
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 Contact
- Name: Özge ONURSAL KILINÇ, MSc
- Phone Number: +905543225606
- Email: ozgeonursal@hotmail.com
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey, 06100
- Recruiting
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation
-
Contact:
- Muhammed KILINÇ, PT, PhD
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Unilateral ischemic / hemorrhagic stroke for more than 3 months
- > 18 years
- Mild-moderate upper extremity impairment (FMA≥30)
- Active shoulder elevation ≥ 90°
- Shoulder girdle muscles spasticity ≤ 2
- Mini Mental State Examination score ≥ 24
Exclusion Criteria:
- Body Mass Index ≤ 30 kg/m2
- Having an allergy to adhesive tape
- Clinical diagnosis of another neurologic disease other than stroke which might effect standing independently
- Having a history of humerus, clavicle and scapula fracture
- Having a shoulder surgery such as rotator cuff muscle repair
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Neurodevelopmental Treatment (Bobath) + Scapular Training Group
|
The Bobath concept for 40 minutes will be formed according to the needs of the individual and involve the upper limb, trunk and lower limb.
It will be performed with 20 minutes scapular training including scapular exercise such as Proprioceptive Neuromuscular Facilitation (PNF), dynamic hug, towel-wall slide, scapular punch exercises etc. 3 days a week for 8 weeks.
|
Active Comparator: Control Group
Neurodevelopmental Treatment (Bobath) Group
|
The Bobath concept for 60 minutes will be formed according to the needs of the individual and involve the upper limb, trunk and lower limb.
It will be performed 3 days a week for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Muscle Thickness with Ultrasonography
Time Frame: change from baseline in muscle thickness of periscapular muscles at 8 weeks
|
The evaluation of muscle thickness of bilateral serratus anterior and lower trapezius muscles with ultrasonography will be performed by a physician using a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK) in resting position.
Muscle Thickness would be expressed as centimeters.
|
change from baseline in muscle thickness of periscapular muscles at 8 weeks
|
Evaluation of Shoulder Subluxation with Ultrasonography
Time Frame: change from baseline in shoulder subluxation at 8 weeks
|
The evaluation of shoulder subluxation with ultrasonography will be performed by a physician using a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK).
It will be performed while the individual is sitting on a chair, the shoulder is in neutral rotation, with the elbow at 90 degrees of flexion and the forearm in pronation.
The fore-arms will rest on a pillow placed on the patient's lap.
The subluxation would be expressed as centimeters.
|
change from baseline in shoulder subluxation at 8 weeks
|
3-Dimensional Scapular Kinematics
Time Frame: change from baseline in scapular kinematics at 8 weeks
|
3-Dimensional Scapular Kinematics will be measured by electromagnetic tracking system (Motion Monitor®, Innovative Sports Training Inc, Chicago) during elevation of the upper extremity on the scapular and sagittal plane and hair combing activity.
|
change from baseline in scapular kinematics at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
Time Frame: change from baseline in upper extremity performance at 8 weeks
|
FMA-UE is a stroke-specific assessment tool to measure the upper limb motor impairment [61], which included shoulder-arm, wrist, hand, coordination and reflexes.
There were 33 items, which scoring on an ordinal scale from 0 to 2. The total score was ranged from 0 to 66.
|
change from baseline in upper extremity performance at 8 weeks
|
Action Research Arm Test (ARAT)
Time Frame: change from baseline in upper extremity performance at 8 weeks
|
ARAT is a performance-based test that evaluates upper extremity function of grasping, gripping, pinching and gross arm movement.
This ordinal scale consists of 19 items.
The quality of the performance on each item was rated from 0 to 3 points.
The total score was ranged from 0 to 57.
|
change from baseline in upper extremity performance at 8 weeks
|
Trunk Impairment Scale
Time Frame: change from baseline in trunk performance at 8 weeks
|
The Trunk Impairment Scale is a reliable and valid scale measuring trunk performance and sitting balance in stroke patients.
It evaluates posture and selective movements of the trunk and contains of three subscales; static and dynamic sitting balance and coordination.
The Trunk Impairment Scale version 2.0.
including only dynamic sitting balance and coordination will be used for measuring trunk performance.
The total score for Trunk Impairment Scale version 2.0.
ranges between 0 and 16.
Higher scores indicate better trunk performance.
|
change from baseline in trunk performance at 8 weeks
|
Visual Analog Scale
Time Frame: change from baseline in pain at 8 weeks
|
Visual Analog Scale is one of the most commonly used methods in determining pain in the literature.
It will be scored by the patients during an activity and the measurement of 3D scapular kinematics and also in resting position.
The pain scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
|
change from baseline in pain at 8 weeks
|
Modified Barthel Index (MBI)
Time Frame: change from baseline in performance of activities of daily living at 8 weeks
|
MBI is an ordinal scale used to measure performance in activities of daily living.
It consists ten items describing activities of daily living such as mobility, dressing, bathing etc. Scores range from 0 (totally dependent) to 100 (fully independent), and higher scores indicates greater independence.
|
change from baseline in performance of activities of daily living at 8 weeks
|
ABILHAND Questionnaire
Time Frame: change from baseline in performance of upper extremity activities of daily living at 8 weeks
|
The ABILHAND is a patient reported assessment for perceived difficulty in using hand to perform manual activities in daily activities such as peeling potatoes with a knife, sharpening a pencil etc.
The ABILHAND version for stroke patients consists 23 bi-manual activities.
Each item can be answered on a 3-level scale (impossible, difficult, easy).
The total score for ABILHAND ranges between 0 and 46.
Higher scores indicate better performance.
|
change from baseline in performance of upper extremity activities of daily living at 8 weeks
|
Stroke Specific Quality of Life Scale
Time Frame: change from baseline in quality of life at 8 weeks
|
The Stroke Specific Quality of Life Scale is a patient-centered outcome measure to assessed the health-related quality of life of stroke survivors.
It is a self-report scale and contains 49 items in 12 domains: mobility, energy, upper extremity function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking, and personality.
Each item is rated on a 5-point Likert scale.
The total score for the scale ranges between 49 and 245.
Higher scores indicate better quality of life.
|
change from baseline in quality of life at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Özge ONURSAL KILINÇ, MSc, Hacettepe University, Faculty of Physical Therapy and Rehabilitation
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)
February 1, 2021
Primary Completion (Anticipated)
November 30, 2022
Study Completion (Anticipated)
November 30, 2022
Study Registration Dates
First Submitted
February 3, 2021
First Submitted That Met QC Criteria
February 3, 2021
First Posted (Actual)
February 8, 2021
Study Record Updates
Last Update Posted (Actual)
March 16, 2022
Last Update Submitted That Met QC Criteria
March 14, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-20074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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