StrokeNCT04743830
Scapular Training in Stroke Individuals
A study testing Neurodevelopmental Treatment (Bobath) + Scapular Training and Neurodevelopmental Treatment (Bobath) in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Neurodevelopmental Treatment (Bobath) + Scapular Training and Neurodevelopmental Treatment (Bobath)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, Altındağ, 06100
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Neurodevelopmental Treatment (Bobath) + Scapular Training, Neurodevelopmental Treatment (Bobath)
- Keywords
- Stroke, Muscle Thickness, Scapula, 3-D Kinematics, Upper Extremity Performance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental Treatment (Bobath) + Scapular TrainingOther
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.
Neurodevelopmental Treatment (Bobath)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Neurodevelopmental Treatment (Bobath) + Scapular Training Group Receives: Other: Neurodevelopmental Treatment (Bobath) + Scapular Training |
| Control Group | Active comparator | Neurodevelopmental Treatment (Bobath) Group Receives: Other: Neurodevelopmental Treatment (Bobath) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline in muscle thickness of periscapular muscles at 8 weeks
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.
Measured: change from baseline in shoulder subluxation at 8 weeks
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.
Measured: change from baseline in scapular kinematics at 8 weeks
Secondary outcomes (7)
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.
Measured: change from baseline in upper extremity performance at 8 weeks
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.
Measured: change from baseline in upper extremity performance at 8 weeks
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.
Measured: change from baseline in trunk performance at 8 weeks
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."
Measured: change from baseline in pain at 8 weeks
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.
Measured: change from baseline in performance of activities of daily living at 8 weeks
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.
Measured: change from baseline in performance of upper extremity activities of daily living at 8 weeks
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.
Measured: change from baseline in quality of life at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Feb 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÖZGE ONURSAL KILINÇ, Hacettepe University
- Investigators
- Özge ONURSAL KILINÇ, MSc, Principal investigator, Hacettepe University, Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743830
- Sponsor's protocol ID
- KA-20074
- Status last verified
- Aug 2025
- First submitted
- 3 Feb 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scapular Training on Scapular Kinematics, Periscapular Muscle Thickness, Shoulder Subluxation and Upper Extremity Functionality in Stroke Individuals
- ClinicalTrials.gov ID
- NCT04743830
- Acronym / sponsor ID
- KA-20074
- Conditions
- Stroke
- Keywords
- Stroke, Muscle Thickness, Scapula, 3-D Kinematics, Upper Extremity Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Neurodevelopmental Treatment (Bobath) + Scapular TrainingNeurodevelopmental Treatment (Bobath) + Scapular Training Group |
| Control Group | Active comparator | Other: Neurodevelopmental Treatment (Bobath)Neurodevelopmental Treatment (Bobath) Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodevelopmental Treatment (Bobath) + Scapular TrainingThe 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. | Other | Treatment Group |
| Neurodevelopmental Treatment (Bobath)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. | Other | Control Group |
Primary outcome
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.
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.
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.
7 secondary outcomes
Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
Time frame: 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
Trunk Impairment Scale
Time frame: change from baseline in trunk performance at 8 weeks
Visual Analog Scale
Time frame: 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
ABILHAND Questionnaire
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özge ONURSAL KILINÇ, MSc principal investigator
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental Treatment (Bobath) + Scapular Training and Neurodevelopmental Treatment (Bobath) in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Muscle Thickness with Ultrasonography (time frame: change from baseline in muscle thickness of periscapular muscles at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.