Scapular Training in Stroke Individuals
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neurodevelopmental Treatment (Bobath) + Scapular Training
Neurodevelopmental Treatment (Bobath)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Muscle Thickness, Scapula, 3-D Kinematics, Upper Extremity Performance
Eligibility Criteria
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
Sites / Locations
- Hacettepe University, Faculty of Physical Therapy and RehabilitationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment Group
Control Group
Arm Description
Neurodevelopmental Treatment (Bobath) + Scapular Training Group
Neurodevelopmental Treatment (Bobath) Group
Outcomes
Primary Outcome Measures
Evaluation of Muscle Thickness with Ultrasonography
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.
Evaluation of Shoulder Subluxation with Ultrasonography
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.
3-Dimensional Scapular Kinematics
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.
Secondary Outcome Measures
Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
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.
Action Research Arm Test (ARAT)
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.
Trunk Impairment Scale
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.
Visual Analog Scale
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."
Modified Barthel Index (MBI)
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.
ABILHAND Questionnaire
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.
Stroke Specific Quality of Life Scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04743830
Brief Title
Scapular Training in Stroke Individuals
Official Title
Effects of Scapular Training on Scapular Kinematics, Periscapular Muscle Thickness, Shoulder Subluxation and Upper Extremity Functionality in Stroke Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Muscle Thickness, Scapula, 3-D Kinematics, Upper Extremity Performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Neurodevelopmental Treatment (Bobath) + Scapular Training Group
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Neurodevelopmental Treatment (Bobath) Group
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental Treatment (Bobath) + Scapular Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental Treatment (Bobath)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of Muscle Thickness with Ultrasonography
Description
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.
Time Frame
change from baseline in muscle thickness of periscapular muscles at 8 weeks
Title
Evaluation of Shoulder Subluxation with Ultrasonography
Description
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.
Time Frame
change from baseline in shoulder subluxation at 8 weeks
Title
3-Dimensional Scapular Kinematics
Description
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.
Time Frame
change from baseline in scapular kinematics at 8 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
Description
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.
Time Frame
change from baseline in upper extremity performance at 8 weeks
Title
Action Research Arm Test (ARAT)
Description
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.
Time Frame
change from baseline in upper extremity performance at 8 weeks
Title
Trunk Impairment Scale
Description
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.
Time Frame
change from baseline in trunk performance at 8 weeks
Title
Visual Analog Scale
Description
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."
Time Frame
change from baseline in pain at 8 weeks
Title
Modified Barthel Index (MBI)
Description
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.
Time Frame
change from baseline in performance of activities of daily living at 8 weeks
Title
ABILHAND Questionnaire
Description
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.
Time Frame
change from baseline in performance of upper extremity activities of daily living at 8 weeks
Title
Stroke Specific Quality of Life Scale
Description
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.
Time Frame
change from baseline in quality of life at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özge ONURSAL KILINÇ, MSc
Phone
+905543225606
Email
ozgeonursal@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özge ONURSAL KILINÇ, MSc
Organizational Affiliation
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammed KILINÇ, PT, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Scapular Training in Stroke Individuals
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