Health TrialsbyHealthPanel

Electrotherapeutic Interventions for Glenohumeral Subluxation After Stroke

ConditionsGlenohumeral SubluxationStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorŞahide Eda ARTUÇ

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • Conventional physiotherapy

    Other intervention

    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.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: NMES GroupExperimental treatment 1 intervention
Group B: EMG Biofeedback GroupExperimental treatment 1 intervention
Group C: Conventional groupActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Şahide Eda ARTUÇ

Lead sponsor

Turkish League Against Rheumatism

Sponsor institution

Source ClinicalTrials.gov

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