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This randomized, sham-controlled clinical trial aims to evaluate the effectiveness of high-intensity laser therapy (HILT) combined with exercise on pain, functional status, disability, and ultrasonographic findings in patients with hemiplegic shoulder pain following stroke.
Hemiplegic shoulder pain (HSP) is a common complication after stroke that significantly affects functional recovery and quality of life. High-intensity laser therapy (HILT) has analgesic, anti-inflammatory, and regenerative effects.
Participants will be randomly assigned into two groups:
HILT + exercise therapy Sham HILT + exercise therapy
The treatment protocol will consist of 20 sessions over 4 weeks (5 sessions per week).
Outcome assessments will be conducted at baseline and at the end of week 4 by blinded assessors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity Laser Therapy + Exercise | Experimental | Participants will receive high-intensity laser therapy combined with a structured exercise program. |
|
| Sham Laser Therapy + Exercise | Sham Comparator | Participants will receive sham laser therapy combined with the same exercise program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Intensity Laser Therapy (HILT) | Device | High-intensity laser therapy will be applied using a 1064 nm wavelength laser device with a peak power up to 3 kW. Each session will deliver approximately 2500 Joules of over 10 minutes. The treatment will be applied to the supraspinatus, deltoid, upper trapezius, pectoralis minor, and biceps tendon regions. The treatment protocol includes fast and slow scanning phases and will be administered 5 days per week for 4 weeks (total 20 sessions). |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Pain and Disability Index (SPADI) | The Shoulder Pain and Disability Index (SPADI) was used to evaluate shoulder-related pain and functional impairment. The index consists of 13 items divided into two subscales: pain (5 items) and disability (8 items). Each item is scored on a 0-10 numerical rating scale, where 0 indicates "no pain/difficulty" and 10 indicates "worst imaginable pain/so difficult it requires help." The total score is calculated by averaging the subscale scores and converting them to a percentage, ranging from 0 to 100. Higher scores represent greater levels of pain and disability. The SPADI is a widely recognized tool with high internal consistency and responsiveness to clinical changes in shoulder conditions. | Baseline and Week 4 |
| Functional Independence Measure (FIM) | Assesses functional independence in activities of daily living. Includes motor and total scores. The functional status of the participants was evaluated using the Functional Independence Measure (FIM). The FIM consists of 18 items, categorized into two main domains: Motor FIM (13 items): Assessing self-care, sphincter control, transfers, and locomotion (score range: 13-91). Cognitive FIM (5 items): Assessing communication and social cognition (score range: 5-35). Each item is scored on a 7-point Likert scale, ranging from 1 (total assistance) to 7 (complete independence). Total scores range from 18 to 126, where higher scores indicate greater functional independence. | Baseline and Week 4 |
| Ultrasonographic Assessment | This description refers to the Ultrasonographic Evaluation of the shoulder. In a Method section, it is important to specify that the exam was performed by a specialist and to list the specific structures visualized. Here is the professional English text for your article: Ultrasonographic Evaluation All participants underwent a standardized musculoskeletal ultrasound (US) examination of the affected shoulder, performed by an experienced [radiologist/physiatrist] using a [Insert Brand, e.g., GE Voluson] system with a high-frequency linear transducer. The examination followed the European Society of Musculoskeletal Radiology (ESSR) guidelines. The sonographic assessment included: Tendon Pathology: Evaluation of the supraspinatus, infraspinatus, and subscapularis tendons for signs of tendinosis, calcifications, and partial or full-thickness tears. The long head of the biceps tendon was also assessed for tenosynovitis or subluxation |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Range of Motion (ROM) | Active and passive range of motion (ROM) for the shoulder joint were measured using a universal goniometer. Measurements included flexion, abduction, and internal/external rotation. To ensure accuracy and reproducibility: Flexion and Abduction: Measured in the supine or seated position, with the goniometer axis aligned with the center of the humeral head. Rotation: Evaluated with the shoulder in 90° of abduction and the elbow in 90° of flexion. All measurements were recorded in degrees (0°-180°). To minimize intra-observer variability, three consecutive measurements were taken for each movement, and the mean value was used for statistical analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali Cagatay Dayı, MD | Contact | 002742600043 | alicagatay.dayi@ksbu.edu.tr | |
| Fatıma YAMAN, Assoc. Prof. | Contact | 002742600043 | fatima.yaman@ksbu.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Fatima YAMAN, Assoc. Prof. | Kutahya Health Sciences University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kutahya Health Sciences University | Kütahya | 43000 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Exercise therapy | Other | Participants will undergo a standardized rehabilitation program including passive, active-assisted, and active range-of-motion exercises. Exercises will be performed in 3 sets of 10 repetitions daily, 5 days per week for 4 weeks. |
|
| Sham Laser Therapy | Device | The same laser device will be used without active energy emission. The procedure, duration, and application areas will be identical to the active laser therapy to maintain blinding. |
|
| Baseline and Week 4 |
| Baseline and Week 4 |
| Modified Ashworth Scale | Spasticity of the [insert muscle group, e.g., elbow flexors/plantar flexors] was assessed using the Modified Ashworth Scale (MAS). The MAS is a clinical tool used to measure the resistance of a muscle to passive stretch at a constant velocity. The scale consists of six scoring levels: 0: No increase in muscle tone. 1: Slight increase in muscle tone, manifested by a catch and release or minimal resistance at the end of the range of motion (ROM). 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM. 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3: Considerable increase in muscle tone, passive movement difficult. 4: Affected part(s) rigid in flexion or extension. | Baseline and Week 4 |
| Brunnstrom Recovery Stages | To round out your Method section, here is the professional English description for the Brunnstrom Recovery Stages (BRS). This scale is specifically used to categorize the motor recovery sequence of post-stroke patients. Brunnstrom Recovery Stages (BRS) The motor recovery of the paretic upper and lower extremities was evaluated using the Brunnstrom Recovery Stages (BRS). This assessment is based on the concept that motor recovery after stroke follows a stereotypical sequence of synergistic movement patterns. The scale consists of six stages for each limb (Hand, Upper Extremity, and Lower Extremity): Stage 1: Flaccidity; no voluntary or reflexive movement. Stage 2: Emergence of basic limb synergies; spasticity begins to develop. Stage 3: Voluntary control of synergies; spasticity reaches its peak. Stage 4: Movements beginning to deviate from basic synergies; spasticity starts to decrease. Stage 5: More complex movements independent of synergies; spasticity continues to decline. | Baseline and Week 4 |
| Pressure Pain Threshold | Pressure Pain Threshold (PPT) The Pressure Pain Threshold (PPT) was measured using a digital pressure algometer (e.g., [Insert Brand, e.g., Wagner FPX™]) equipped with a 1 cm² rubber-tipped probe. Measurements were performed over the mid-deltoid muscle of the affected shoulder. The procedure was standardized as follows: The probe was applied perpendicular to the skin surface, with pressure increasing at a constant rate of approximately 1 kg/cm²/s. Participants were instructed to indicate the exact moment the sensation of "pressure" changed to "pain" or "discomfort." Three consecutive measurements were taken at the same anatomical site with a 30-second resting interval between trials. The mean value of the three measurements, expressed in kilograms per square centimeter (kg/cm²), was recorded as the PPT. Higher values indicate higher pain tolerance, while lower values suggest mechanical hyperalgesia. | Baseline and Week 4 |
| Acromiohumeral Distance | This measurement, often abbreviated as AHD, is a critical sonographic marker for subacromial impingement syndrome and rotator cuff integrity.Here is the professional English text for your Method section:Acromiohumeral Distance (AHD)The Acromiohumeral Distance (AHD) was measured using ultrasonography to assess the subacromial space. The AHD is defined as the shortest linear distance between the tangential point of the inferior edge of the acromion and the superior aspect of the humeral head.Measurements were performed with the patient in a standardized seated position, with the arm in a neutral position and the forearm resting on the thigh. A high-frequency linear transducer was placed longitudinally along the long axis of the humerus. The following protocol was observed:Measurement Unit: Recorded in millimeters (mm). | Baseline and Week 4 |
| Supraspinatus Tendon Thickness and occupation ratio | The Supraspinatus Tendon Thickness (STT) was measured via ultrasonography at the thickest point of the tendon, approximately 1 cm lateral to the long head of the biceps tendon in the longitudinal plane. Occupation Ratio indicates that the supraspinatus tendon occupies a larger proportion of the subacromial space, which may be associated with mechanical compression during shoulder movement. All measurements were recorded in millimeters (mm), and the ratio was expressed as a percentage (%). | Baseline and Week 4 |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |