Comparison of the Clinical and Sonographic Outcomes of NMES and EMG Biofeedback Therapies in Stroke Patients With Glenohumeral Subluxation: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Acromion-Greater Tuberosity Distance (AGT Distance) - Musculoskeletal Ultrasound Measurement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigator performing sonographic and clinical outcome assessments will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
研究组 & 干预措施
NMES Group
Fifteen sessions of NMES with conventional physiotherapy
干预措施: Neuromuscular electrical stimulation (Device)
EMG Biofeedback Group
Fifteen sessions of Electromyographic (EMG) biofeedback therapy with conventional physiotherapy
干预措施: Electromyographic (EMG) biofeedback (Device)
Conventional group
Conventional physiotherapy
干预措施: Conventional physiotherapy (Other)
结局指标
主要结局
Acromion-Greater Tuberosity Distance (AGT Distance) - Musculoskeletal Ultrasound Measurement
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Şahide Eda ARTUÇ
Principal Investigator, MD, Physical Medicine and Rehabilitation Specialist
Turkish League Against Rheumatism