Hemiplegia and/or Hemiparesis Following StrokeNCT07501416
High-Intensity Laser Therapy in Hemiplegic Shoulder Pain
A study testing High-Intensity Laser Therapy (HILT) and Exercise therapy in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hemiplegia and/or Hemiparesis Following Stroke
- What is being tested?
- High-Intensity Laser Therapy (HILT) and Exercise therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-75 years
- Hemiplegic shoulder pain after stroke
- Stroke within last 6 months
- VAS ≥ 3 for pain
- Medically stable
Who cannot join
- Neurological disorders (MS, Parkinson, etc.)
- Recent shoulder surgery/injection
- Botulinum toxin (last 6 months)
- Malignancy
- Pregnancy
- Epilepsy or photosensitivity
- Cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kutahya Health Sciences University
Kütahya, Center, 43000
Ali Cagtay DAYI, MD, 002742600043, alicagtay.dayi@ksbu.edu.tr
Fatima YAMAN, Assoc. Prof., 002742600043, fatima.yamanq@ksbu.edu.tr
About this study
Official title: Effectiveness of High-Intensity Laser Therapy Combined With Exercise on Clinical and Ultrasonographic Outcomes in Patients With Hemiplegic Shoulder Pain
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.
Read the detailed description
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.
- Being tested
- High-Intensity Laser Therapy (HILT), Exercise therapy, Sham Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Exercise therapyOther
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser Therapy + Exercise | Experimental | Participants will receive high-intensity laser therapy combined with a structured exercise program. Receives: Device: High-Intensity Laser Therapy (HILT); Other: Exercise therapy |
| Sham Laser Therapy + Exercise | Sham comparator | Participants will receive sham laser therapy combined with the same exercise program. Receives: Other: Exercise therapy; Device: Sham Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline and Week 4
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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 (%).
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia and/or Hemiparesis Following StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Yaman, Kutahya Health Sciences University
- Investigators
- Fatima YAMAN, Assoc. Prof., Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501416
- Sponsor's protocol ID
- CagatayTez
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-Intensity Laser Therapy Combined With Exercise on Clinical and Ultrasonographic Outcomes in Patients With Hemiplegic Shoulder Pain
- ClinicalTrials.gov ID
- NCT07501416
- Acronym / sponsor ID
- CagatayTez
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy + Exercise | Experimental | Device: High-Intensity Laser Therapy (HILT), Other: Exercise therapyParticipants will receive high-intensity laser therapy combined with a structured exercise program. |
| Sham Laser Therapy + Exercise | Sham comparator | Other: Exercise therapy, Device: Sham Laser TherapyParticipants will receive sham laser therapy combined with the same exercise program. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30-75 years
- Hemiplegic shoulder pain after stroke
- Stroke within last 6 months
- VAS ≥ 3 for pain
- Medically stable
Key exclusion criteria (7 listed)
- Neurological disorders (MS, Parkinson, etc.)
- Recent shoulder surgery/injection
- Botulinum toxin (last 6 months)
- Malignancy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Laser Therapy (HILT)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). | Device | High-Intensity Laser Therapy + Exercise |
| Exercise therapyParticipants 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. | Other | High-Intensity Laser Therapy + Exercise, Sham Laser Therapy + Exercise |
| Sham Laser TherapyThe 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. | Device | Sham Laser Therapy + Exercise |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline and Week 4
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.
Functional Independence Measure (FIM)
Time frame: Baseline and Week 4
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.
Ultrasonographic Assessment
Time frame: Baseline and Week 4
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
6 secondary outcomes
Shoulder Range of Motion (ROM)
Time frame: Baseline and Week 4
Modified Ashworth Scale
Time frame: Baseline and Week 4
Brunnstrom Recovery Stages
Time frame: Baseline and Week 4
Pressure Pain Threshold
Time frame: Baseline and Week 4
Acromiohumeral Distance
Time frame: Baseline and Week 4
Supraspinatus Tendon Thickness and occupation ratio
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatima YAMAN, Assoc. Prof. principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Laser Therapy (HILT) and Exercise therapy in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Cagtay Dayı, MD (002742600043, alicagtay.dayi@ogr.ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index (SPADI) (time frame: Baseline and Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.