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NCT Number: NCT07423455

Electrotherapeutic Interventions for Glenohumeral Subluxation After Stroke

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.

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Key information

Conditions

Glenohumeral Subluxation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Joint Diseases Joint Dislocations Musculoskeletal Diseases Nervous System Diseases Shoulder Dislocation Shoulder Injuries Stroke Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Ankara, Turkey (Türkiye)

Location contact

EDA GÜRÇAY, Professor

SUB_INVESTIGATOR

RABİA B KÖKÇEK ADIGÜZEL, MD

SUB_INVESTIGATOR

RABİA LAYIK ARSLAN, MD

SUB_INVESTIGATOR

ŞAHİDE E ARTUÇ, MD

CONTACT

[email protected]

+905534488730

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: NMES

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.

Other names: EMG Biofeedback

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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.

Secondary outcomes

  1. Visual Analog Scale

    Time frame: Baseline and Week 3

    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.

  2. Passive Shoulder Range of Motion (ROM)

    Time frame: Baseline and Week 3

    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.

  3. Shoulder Pain and Disability Index (SPADI)

    Time frame: Baseline and Week 3

    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.

  4. Stroke-Specific Quality of Life Scale (SS-QOL)

    Time frame: Baseline and Week 3

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ŞAHİDE E ARTUÇ, MD

CONTACT

[email protected]

+905534488730

Sponsors and collaborators

Lead sponsor

Şahide Eda Artuç

Other

Registry information

Official study title

Comparison of the Clinical and Sonographic Outcomes of NMES and EMG Biofeedback Therapies in Stroke Patients With Glenohumeral Subluxation: Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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