Electrotherapeutic Interventions for Glenohumeral Subluxation After Stroke

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Glenohumeral Subluxation
• Intervention / Treatment: Device: Neuromuscular electrical stimulation; Device: Electromyographic (EMG) biofeedback; Other: Conventional physiotherapy

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ŞAHİDE E ARTUÇ, MD; Phone Number: +905534488730; Email: edartuc@gmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
    • Contact: ŞAHİDE E ARTUÇ, MD; Phone Number: +905534488730; Email: edartuc@gmail.com
    • Sub-Investigator: RABİA B KÖKÇEK ADIGÜZEL, MD
    • Sub-Investigator: RABİA LAYIK ARSLAN, MD
    • Sub-Investigator: EDA GÜRÇAY, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NMES Group; Fifteen sessions of NMES with conventional physiotherapy	Device: Neuromuscular 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.; Other Names: NMES
Experimental: EMG Biofeedback Group; Fifteen sessions of Electromyographic (EMG) biofeedback therapy with conventional physiotherapy	Device: Electromyographic (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.; Other Names: EMG Biofeedback
Active Comparator: Conventional group; Conventional physiotherapy	Other: Conventional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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.	Baseline and Week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline and Week 3

Collaborators and Investigators

• Sponsor: Şahide Eda Artuç

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 27, 2026
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): December 27, 2026

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: stroke; NMES; EMG Biofeedback; glenohumeral subluxation; Electrotherapeutic Interventions
• Additional Relevant MeSH Terms: Shoulder Injuries; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Joint Diseases; Joint Dislocations; Stroke; Shoulder Dislocation; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Electrodiagnosis; Myography; Electromyography; Biofeedback, Psychology
• Other Study ID Numbers: AEŞH-EK-2025-115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for at least 5 years.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No