Glenohumeral Subluxation, Stroke
Conditions
Keywords
stroke, glenohumeral subluxation, Electrotherapeutic Interventions, NMES, EMG Biofeedback
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.
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.
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.
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.
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.
Sponsors
Şahide Eda ARTUÇ
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The investigator performing sonographic and clinical outcome assessments will be blinded to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acromion-Greater Tuberosity Distance (AGT Distance) - Musculoskeletal Ultrasound Measurement | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 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. |
| Passive Shoulder Range of Motion (ROM) | 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. |
| Shoulder Pain and Disability Index (SPADI) | 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. |
| Stroke-Specific Quality of Life Scale (SS-QOL) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTŞAHİDE E ARTUÇ, MD
Outcome results
None listed