Electrotherapeutic Interventions for Glenohumeral Subluxation After Stroke

NCT07423455 | Not Yet Recruiting

• 1 other identifier: AEŞH-EK-2025-115
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glenohumeral Subluxation; Stroke

Keywords

stroke; glenohumeral subluxation; Electrotherapeutic Interventions; NMES; EMG Biofeedback

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Visual Analog Scale

  Baseline and Week 3

• Passive Shoulder Range of Motion (ROM)

  Baseline and Week 3

• Shoulder Pain and Disability Index (SPADI)

  Baseline and Week 3

• Stroke-Specific Quality of Life Scale (SS-QOL)

  Baseline and Week 3

Study Arms (3)

NMES Group

EXPERIMENTAL

Fifteen sessions of NMES with conventional physiotherapy

Device: Neuromuscular electrical stimulation

EMG Biofeedback Group

EXPERIMENTAL

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

Device: Electromyographic (EMG) biofeedback

Conventional group

ACTIVE COMPARATOR

Conventional physiotherapy

Other: Conventional physiotherapy

Interventions

Neuromuscular electrical stimulation DEVICE

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

NMES Group

Electromyographic (EMG) biofeedback DEVICE

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

EMG Biofeedback Group

Conventional physiotherapy OTHER

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.

Conventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Şahide Eda ARTUÇ: lead

Study Sites (1)

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31453469 BACKGROUND

• 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.

  PMID: 31298627 BACKGROUND

• 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.

  PMID: 29183339 BACKGROUND

MeSH Terms

Conditions

Shoulder Dislocation; Stroke

Interventions

Electromyography; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

ŞAHİDE E ARTUÇ, MD

CONTACT

+905534488730; edartuc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator performing sonographic and clinical outcome assessments will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MD, Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: February 20, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): December 27, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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

Locations

TU (1)