ClinicalTrials.gg
Not yet recruitingNCT07423455Updated Feb 20, 2026

Electrotherapeutic Interventions for Glenohumeral Subluxation After Stroke

An interventional study of Neuromuscular electrical stimulation and Electromyographic (EMG) biofeedback in Glenohumeral Subluxation and Stroke, sponsored by Şahide Eda ARTUÇ. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by Şahide Eda ARTUÇ · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Glenohumeral Subluxation
  • Stroke

Keywords

  • stroke
  • glenohumeral subluxation
  • Electrotherapeutic Interventions
  • NMES
  • EMG Biofeedback
03

In context

Shoulder Dislocation

105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.

This study's planned enrollment of 36 is below the median of 60 across 71 interventional studies indexed under Shoulder Dislocation.

Browse Shoulder Dislocation studies →

Lead sponsor

Şahide Eda ARTUÇ is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥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

Exclusion criteria

Exclusion Criteria:

  • (MMSE) score \<24,
  • Visual/hearing impairments, or neglect,
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    NMES Group

    Fifteen sessions of NMES with conventional physiotherapy

    Device: Neuromuscular electrical stimulation

  • Experimental
    EMG Biofeedback Group

    Fifteen sessions of Electromyographic (EMG) biofeedback therapy with conventional physiotherapy

    Device: Electromyographic (EMG) biofeedback

  • Active comparator
    Conventional group

    Conventional physiotherapy

    Other: Conventional physiotherapy

Interventions

  • DeviceNeuromuscular electrical stimulation

    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.

    Also known as: NMES

  • DeviceElectromyographic (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.

    Also known as: EMG Biofeedback

  • OtherConventional physiotherapy

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline and Week 3

  2. 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)

    Time frame: Baseline (Week 0) and Week 3

  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)

    Time frame: Baseline (Week 0) and Week 3

  4. 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.

    Time frame: Baseline and Week 3

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 3

  2. 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.

    Time frame: Baseline and Week 3

  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.

    Time frame: Baseline and Week 3

  4. 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.

    Time frame: Baseline and Week 3

07

Study locations

1 site
  • Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
    Ankara, Turkey (Türkiye)
    • ŞAHİDE E ARTUÇ, MD · Contactedartuc@gmail.com · +905534488730
    • RABİA B KÖKÇEK ADIGÜZEL, MD · Sub investigator
    • RABİA LAYIK ARSLAN, MD · Sub investigator
    • EDA GÜRÇAY, Professor · Sub investigator
08

References and documents

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 31453469 ↗
  • Whitehair 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 31298627 ↗
  • Chuang 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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years.

Access criteria: Qualified researchers affiliated with academic or medical institutions may request access by contacting the principal investigator. Access will be granted after approval of a proposal and signing of a data use agreement

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2026; primary completion for Sep 2026, 7 months later.

Of 39 non-industry interventional studies with no phase under Shoulder Dislocation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 7 months is below that.

Counting every sponsor, half of 39 studies reached it within 22 months; a quarter within 11 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2025
First posted
Feb 20, 2026
StartEst.
Feb 27, 2026
Primary completionEst.
Sep 27, 2026
CompletionEst.
Dec 27, 2026
Last update
Feb 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07423455
Lead sponsor
Şahide Eda ARTUÇ
Responsible party
Şahide Eda ARTUÇ (Principal Investigator, MD, Physical Medicine and Rehabilitation Specialist, Turkish League Against Rheumatism) — Sponsor-investigator
First posted
Feb 20, 2026
Start date
Feb 27, 2026 (estimated)
Primary completion
Sep 27, 2026 (estimated)
Completion
Dec 27, 2026 (estimated)
Last update
Feb 20, 2026

Study contacts

ŞAHİDE E ARTUÇ, MD
Contact
edartuc@gmail.com
+905534488730

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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