Glenohumeral SubluxationNCT07423455
Electrotherapeutic Interventions for Glenohumeral Subluxation After Stroke
A study testing Neuromuscular electrical stimulation, Electromyographic (EMG) biofeedback and Conventional physiotherapy in people with Glenohumeral Subluxation and Stroke, run by Şahide Eda ARTUÇ at 1 site in Turkey (Türkiye).
Trial summary
The aim of this single-blind randomized controlled trial is to compare the effects of two therapies-neuromuscular electrical stimulation (NMES) and electromyographic (EMG) biofeedback-in stroke patients with shoulder (glenohumeral) subluxation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glenohumeral Subluxation, Stroke
- What is being tested?
- Neuromuscular electrical stimulation, Electromyographic (EMG) biofeedback and Conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2026to 27 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age,
- Disease duration >3 months,
- Glenohumeral subluxation (GHS) confirmed by ultrasonography (USG),
- Upper extremity and hand Brunnstrom motor stages between 2 and 5
Who cannot join
- Mini-Mental State Examination (MMSE) score <24,
- Visual/hearing impairments, or neglect,
- Steroid injection for shoulder pain within the last 3 months,
- Unstable systemic disease,
- Spasticity with Modified Ashworth Scale (MAS) score 3-4,
- Presence of metal implants or pacemaker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
Ankara
ŞAHİDE E ARTUÇ, MD, +905534488730, edartuc@gmail.com
RABİA B KÖKÇEK ADIGÜZEL, MD
About this study
Official title: Comparison of the Clinical and Sonographic Outcomes of NMES and EMG Biofeedback Therapies in Stroke Patients With Glenohumeral Subluxation: Randomized Clinical Trial
The aim of this single-blind randomized controlled trial is to compare the effects of two therapies-neuromuscular electrical stimulation (NMES) and electromyographic (EMG) biofeedback-in stroke patients with shoulder (glenohumeral) subluxation.
The study will evaluate changes in shoulder structure and function by measuring the acromion-greater tuberosity distance, supraspinatus and posterior deltoid muscle thickness, shoulder range of motion, and Brunnstrom stage of the upper extremity and hand. Clinical outcomes such as shoulder pain, stroke-specific quality of life, and the Shoulder Pain and Disability Index (SPADI) will also be assessed.
This trial is designed to provide evidence on which therapy may be more effective for improving shoulder stability, reducing pain, and enhancing quality of life in stroke survivors with shoulder subluxation.
Read the detailed description
Shoulder (glenohumeral) subluxation is a common complication after stroke and is associated with pain, impaired upper limb function, and decreased quality of life. Despite the availability of different rehabilitation methods, there is still no clear consensus on the most effective approach for managing post-stroke shoulder subluxation.
The aim of this single-blind, randomized controlled trial is to compare the effects of two electrotherapeutic interventions-neuromuscular electrical stimulation (NMES) and electromyographic (EMG) biofeedback-on both structural and functional outcomes in stroke patients with glenohumeral subluxation.
Participants will be randomly assigned to either the NMES group or the EMG biofeedback group, in addition to receiving standard rehabilitation. The study will evaluate structural outcomes using ultrasonographic measures, including the acromion-greater tuberosity distance and supraspinatus and posterior deltoid muscle thickness. Functional outcomes will include shoulder range of motion and Brunnstrom stages of the upper extremity and hand. Clinical outcomes will be assessed using pain scores, the Stroke-Specific Quality of Life Scale, and the Shoulder Pain and Disability Index (SPADI).
This trial is expected to provide evidence regarding the comparative effectiveness of NMES and EMG biofeedback in improving shoulder stability, reducing pain, and enhancing functional recovery and quality of life in stroke survivors with shoulder subluxation.
- Conditions
- Glenohumeral Subluxation, Stroke
- Being tested
- Neuromuscular electrical stimulation, Electromyographic (EMG) biofeedback, Conventional physiotherapy
- Keywords
- stroke, glenohumeral subluxation, Electrotherapeutic Interventions, NMES, EMG Biofeedback
- Medical subject headings
- Shoulder Dislocation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
Also called NMES
Neuromuscular electrical stimulation (NMES) will be administered to the supraspinatus and posterior deltoid muscles for 20 minutes daily, five days per week, over a period of three weeks, totaling 15 treatment sessions. All groups will undergo a conventional physiotherapy program consisting of 45-minute sessions, five days per week, for three weeks, totaling 15 sessions. The program will comprise range of motion exercises, stretching, progressive resistive exercises, and activities of daily living-oriented exercises.
Electromyographic (EMG) biofeedbackDevice
Also called EMG Biofeedback
Electromyographic (EMG) biofeedback therapy will be applied to the supraspinatus and posterior deltoid muscles for 20 minutes daily, five days per week, over a period of three weeks, totaling 15 treatment sessions. All groups will undergo a conventional physiotherapy program consisting of 45-minute sessions, five days per week, for three weeks, totaling 15 sessions. The program will comprise range of motion exercises, stretching, progressive resistive exercises, and activities of daily living-oriented exercises.
Conventional physiotherapyOther
This group will participate exclusively in a conventional physiotherapy program for 45 minutes daily, five days per week, over a period of three weeks, totaling 15 sessions. The conventional program will include range of motion exercises, stretching, progressive resistive exercises, and exercises targeting activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| NMES Group | Experimental | Fifteen sessions of NMES with conventional physiotherapy Receives: Device: Neuromuscular electrical stimulation |
| EMG Biofeedback Group | Experimental | Fifteen sessions of Electromyographic (EMG) biofeedback therapy with conventional physiotherapy Receives: Device: Electromyographic (EMG) biofeedback |
| Conventional group | Active comparator | Conventional physiotherapy Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acromion-Greater Tuberosity Distance (AGT Distance) - Musculoskeletal Ultrasound Measurement
"The acromion-greater tuberosity (AGT) distance will be measured using standardized musculoskeletal ultrasound. The measurement will be performed on the hemiparetic shoulder with the participant in a seated position. The AGT distance represents the linear distance between the lateral edge of the acromion and the greater tuberosity of the humerus."
Unit of Measure: millimeters (mm)
Measured: Baseline and Week 3
Supraspinatus Muscle Thickness Measured by Musculoskeletal Ultrasound
Supraspinatus muscle thickness will be measured at the predefined anatomic landmark on the hemiparetic side using musculoskeletal ultrasound. Increased muscle thickness after intervention will be interpreted as improved muscle activation or preservation. Unit of Measure: millimeters (mm)
Measured: Baseline (Week 0) and Week 3
Posterior Deltoid Muscle Thickness Measured by Musculoskeletal Ultrasound
Posterior deltoid muscle thickness will be measured on the affected side using musculoskeletal ultrasound with the same probe position and gain settings at each visit. Increased thickness will be interpreted as improved muscle recruitment or prevention of disuse atrophy. Unit of Measure:millimeters (mm)
Measured: Baseline (Week 0) and Week 3
Motor Function
Motor recovery will be evaluated using the Brunnstrom Motor Recovery Stages, a 6-stage clinical scale that assesses motor recovery after stroke. The Brunnstrom Motor Recovery Stages assess the upper extremity, hand and lower extremity separately. A score of 1 represents the poorest motor function, whereas a score of 6 represents the best motor function. In this study, the Brunnstrom scale will be applied to evaluate the upper extremity and hand.
Measured: Baseline and Week 3
Secondary outcomes (4)
Visual Analog Scale
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will mark their current pain level on the scale at each assessment.
Measured: Baseline and Week 3
Passive Shoulder Range of Motion (ROM)
Passive shoulder range of motion (ROM) will be measured using a goniometer, including flexion, abduction. Measurements will assess the functional mobility of the shoulder joint without active muscle contraction by the participant.
Measured: Baseline and Week 3
Shoulder Pain and Disability Index (SPADI)
Shoulder pain and disability will be evaluated using the Shoulder Pain and Disability Index (SPADI), a validated questionnaire that assesses pain and functional limitations of the shoulder. Scores range from 0 to 100, where 0 indicates no pain or disability and 100 indicates the worst pain and maximum disability.
Measured: Baseline and Week 3
Stroke-Specific Quality of Life Scale (SS-QOL)
Quality of life will be assessed using the Stroke-Specific Quality of Life Scale (SS-QOL), a validated questionnaire measuring physical, emotional and social domains specific to stroke survivors. Scores range from 49 to 245, with higher scores indicating better quality of life.
Measured: Baseline and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start27 Feb 2026 (estimated)
- Primary completion27 Sep 2026 (estimated)
- Study completion27 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glenohumeral SubluxationStudies of the same condition, open and under way.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Şahide Eda ARTUÇ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şahide Eda ARTUÇ, Turkish League Against Rheumatism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423455
- Sponsor's protocol ID
- AEŞH-EK-2025-115
- Status last verified
- Jan 2026
- First submitted
- 29 Sep 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including baseline characteristics and outcome measures, will be shared with qualified researchers upon reasonable request. Data will be available after publication of the main results.
Publications
Turkkan C, Ozturk GT, Ugurlu FG, Ersoz M. Ultrasonographic assessment of neuromuscular electrical stimulation efficacy on glenohumeral subluxation in patients with hemiplegia: a randomized-controlled study. Turk J Phys Med Rehabil. 2017 May 17;63(4):287-292. doi: 10.5606/tftrd.2017.953. eCollection 2017 Dec.
PubMed 31453469Whitehair VC, Chae J, Hisel T, Wilson RD. The effect of electrical stimulation on impairment of the painful post-stroke shoulder. Top Stroke Rehabil. 2019 Oct;26(7):544-547. doi: 10.1080/10749357.2019.1633796. Epub 2019 Jul 12.
PubMed 31298627Chuang LL, Chen YL, Chen CC, Li YC, Wong AM, Hsu AL, Chang YJ. Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm function after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2017 Nov 28;14(1):122. doi: 10.1186/s12984-017-0332-0.
PubMed 29183339
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical and Sonographic Outcomes of NMES and EMG Biofeedback Therapies in Stroke Patients With Glenohumeral Subluxation: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07423455
- Acronym / sponsor ID
- AEŞH-EK-2025-115
- Conditions
- Glenohumeral Subluxation, Stroke
- Keywords
- stroke, glenohumeral subluxation, Electrotherapeutic Interventions, NMES, EMG Biofeedback
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Şahide Eda ARTUÇUniversity, hospital or other
- Study start
- 27 Feb 2026 (estimated)
- Primary completion
- 27 Sep 2026 (estimated)
- Study completion
- 27 Dec 2026 (estimated)
- First posted
- 20 Feb 2026 (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.
The aim of this single-blind randomized controlled trial is to compare the effects of two therapies-neuromuscular electrical stimulation (NMES) and electromyographic (EMG) biofeedback-in stroke patients with shoulder (glenohumeral) subluxation.
The study will evaluate changes in shoulder structure and function by measuring the acromion-greater tuberosity distance, supraspinatus and posterior deltoid muscle thickness, shoulder range of motion, and Brunnstrom stage of the upper extremity and hand. Clinical outcomes such as shoulder pain, stroke-specific quality of life, and the Shoulder Pain and Disability Index (SPADI) will also be assessed.
This trial is designed to provide evidence on which therapy may be more effective for improving shoulder stability, reducing pain, and enhancing quality of life in stroke survivors with shoulder subluxation.
Detailed description
Shoulder (glenohumeral) subluxation is a common complication after stroke and is associated with pain, impaired upper limb function, and decreased quality of life. Despite the availability of different rehabilitation methods, there is still no clear consensus on the most effective approach for managing post-stroke shoulder subluxation.
The aim of this single-blind, randomized controlled trial is to compare the effects of two electrotherapeutic interventions-neuromuscular electrical stimulation (NMES) and electromyographic (EMG) biofeedback-on both structural and functional outcomes in stroke patients with glenohumeral subluxation.
Participants will be randomly assigned to either the NMES group or the EMG biofeedback group, in addition to receiving standard rehabilitation. The study will evaluate structural outcomes using ultrasonographic measures, including the acromion-greater tuberosity distance and supraspinatus and posterior deltoid muscle thickness. Functional outcomes will include shoulder range of motion and Brunnstrom stages of the upper extremity and hand. Clinical outcomes will be assessed using pain scores, the Stroke-Specific Quality of Life Scale, and the Shoulder Pain and Disability Index (SPADI).
This trial is expected to provide evidence regarding the comparative effectiveness of NMES and EMG biofeedback in improving shoulder stability, reducing pain, and enhancing functional recovery and quality of life in stroke survivors with shoulder subluxation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMES Group | Experimental | Device: Neuromuscular electrical stimulationFifteen sessions of NMES with conventional physiotherapy |
| EMG Biofeedback Group | Experimental | Device: Electromyographic (EMG) biofeedbackFifteen sessions of Electromyographic (EMG) biofeedback therapy with conventional physiotherapy |
| Conventional group | Active comparator | Other: Conventional physiotherapyConventional physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age,
- Disease duration >3 months,
- Glenohumeral subluxation (GHS) confirmed by ultrasonography (USG),
- Upper extremity and hand Brunnstrom motor stages between 2 and 5
Key exclusion criteria (6 listed)
- Mini-Mental State Examination (MMSE) score <24,
- Visual/hearing impairments, or neglect,
- Steroid injection for shoulder pain within the last 3 months,
- Unstable systemic disease,
- Spasticity with Modified Ashworth Scale (MAS) score 3-4,
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 |
|---|---|---|
| Neuromuscular electrical stimulationAlso: NMESNeuromuscular electrical stimulation (NMES) will be administered to the supraspinatus and posterior deltoid muscles for 20 minutes daily, five days per week, over a period of three weeks, totaling 15 treatment sessions. All groups will undergo a conventional physiotherapy program consisting of 45-minute sessions, five days per week, for three weeks, totaling 15 sessions. The program will comprise range of motion exercises, stretching, progressive resistive exercises, and activities of daily living-oriented exercises. | Device | NMES Group |
| Electromyographic (EMG) biofeedbackAlso: EMG BiofeedbackElectromyographic (EMG) biofeedback therapy will be applied to the supraspinatus and posterior deltoid muscles for 20 minutes daily, five days per week, over a period of three weeks, totaling 15 treatment sessions. All groups will undergo a conventional physiotherapy program consisting of 45-minute sessions, five days per week, for three weeks, totaling 15 sessions. The program will comprise range of motion exercises, stretching, progressive resistive exercises, and activities of daily living-oriented exercises. | Device | EMG Biofeedback Group |
| Conventional physiotherapyThis group will participate exclusively in a conventional physiotherapy program for 45 minutes daily, five days per week, over a period of three weeks, totaling 15 sessions. The conventional program will include range of motion exercises, stretching, progressive resistive exercises, and exercises targeting activities of daily living. | Other | Conventional group |
Primary outcome
Acromion-Greater Tuberosity Distance (AGT Distance) - Musculoskeletal Ultrasound Measurement
Time frame: Baseline and Week 3
"The acromion-greater tuberosity (AGT) distance will be measured using standardized musculoskeletal ultrasound. The measurement will be performed on the hemiparetic shoulder with the participant in a seated position. The AGT distance represents the linear distance between the lateral edge of the acromion and the greater tuberosity of the humerus." Unit of Measure: millimeters (mm)
Supraspinatus Muscle Thickness Measured by Musculoskeletal Ultrasound
Time frame: Baseline (Week 0) and Week 3
Supraspinatus muscle thickness will be measured at the predefined anatomic landmark on the hemiparetic side using musculoskeletal ultrasound. Increased muscle thickness after intervention will be interpreted as improved muscle activation or preservation. Unit of Measure: millimeters (mm)
Posterior Deltoid Muscle Thickness Measured by Musculoskeletal Ultrasound
Time frame: Baseline (Week 0) and Week 3
Posterior deltoid muscle thickness will be measured on the affected side using musculoskeletal ultrasound with the same probe position and gain settings at each visit. Increased thickness will be interpreted as improved muscle recruitment or prevention of disuse atrophy. Unit of Measure:millimeters (mm)
Motor Function
Time frame: Baseline and Week 3
Motor recovery will be evaluated using the Brunnstrom Motor Recovery Stages, a 6-stage clinical scale that assesses motor recovery after stroke. The Brunnstrom Motor Recovery Stages assess the upper extremity, hand and lower extremity separately. A score of 1 represents the poorest motor function, whereas a score of 6 represents the best motor function. In this study, the Brunnstrom scale will be applied to evaluate the upper extremity and hand.
4 secondary outcomes
Visual Analog Scale
Time frame: Baseline and Week 3
Passive Shoulder Range of Motion (ROM)
Time frame: Baseline and Week 3
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline and Week 3
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: Baseline and Week 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 31453469Turkkan C, Ozturk GT, Ugurlu FG, Ersoz M. Ultrasonographic assessment of neuromuscular electrical stimulation efficacy on glenohumeral subluxation in patients with hemiplegia: a randomized-controlled study. Turk J Phys Med Rehabil. 2017 May 17;63(4):287-292. doi: 10.5606/tftrd.2017.953. eCollection 2017 Dec.
- Background: PubMed 31298627Whitehair VC, Chae J, Hisel T, Wilson RD. The effect of electrical stimulation on impairment of the painful post-stroke shoulder. Top Stroke Rehabil. 2019 Oct;26(7):544-547. doi: 10.1080/10749357.2019.1633796. Epub 2019 Jul 12.
- Background: PubMed 29183339Chuang LL, Chen YL, Chen CC, Li YC, Wong AM, Hsu AL, Chang YJ. Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm function after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2017 Nov 28;14(1):122. doi: 10.1186/s12984-017-0332-0.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including baseline characteristics and outcome measures, will be shared with qualified researchers upon reasonable request. Data will be available after publication of the main results.
Related trials for Glenohumeral Subluxation
Not yet recruitingObservational study
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Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
Active, not recruiting
The Effects of Upper-Extremity Plyometric Combined Strength Training in Overhead Athletes With Shoulder Instability
Glenohumeral Subluxation, Shoulder Subluxation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation, Electromyographic (EMG) biofeedback and Conventional physiotherapy in people with Glenohumeral Subluxation and Stroke, run by Şahide Eda ARTUÇ 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ŞAHİDE E ARTUÇ, MD (+905534488730, edartuc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acromion-Greater Tuberosity Distance (AGT Distance) - Musculoskeletal Ultrasound Measurement (time frame: Baseline and Week 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07423455, which also lists 3 linked publications.
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 20 Feb 2026.