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The aim of this study is to investigate the effectiveness of high-intensity laser therapy for treating plantar flexor muscle spasticity in subacute and chronic stroke patients, focusing on its impact on spasticity, joint range of motion, pain, muscle thickness, functional ambulation, and quality of life.
Post-stroke lower limb spasticity disrupts balance and walking, often resulting in decreased walking speed, increased wheelchair use, and the need for caregiver assistance. Various approaches are utilized in spasticity management, including physical therapy, splinting, oral medications, chemical neurolysis, and surgical interventions. Laser therapy is a non-invasive, painless modality used in physiotherapy units, with a low incidence of side effects. Laser therapy has been shown to reduce muscle fatigue and increase peak torque (muscle strength) when applied before exercise. The use of high-intensity laser therapy in physiotherapy protocols has become increasingly common in recent years. Studies suggest that it enhances healing in tendons and ligaments, prevents fibrosis development, increases local blood flow and tissue regeneration, and reduces edema and pain. The aim of this study is to investigate the effectiveness of high-intensity laser therapy for treating plantar flexor muscle spasticity in subacute and chronic stroke patients, focusing on its impact on spasticity, joint range of motion, pain, muscle thickness, functional ambulation, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity laser therapy group | Active Comparator | High-intensity laser will be applied continuously to the gastrocnemius muscle for a total of 10 minutes with an energy density of 100 j/cm2, totaling 2500 j. |
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| Sham group | Sham Comparator | The same procedure will be followed, but sham laser will be applied at 0 j/cm2 for 10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity laser | Device | All patients will receive a rehabilitation program consisting of stretching, strengthening, balance, and walking exercises targeting the lower extremities for 45 minutes, 5 days a week, for 6 weeks. Walking training will initially begin on level ground and gradually progress to different levels and surfaces. High-intensity laser will be applied continuously in biostimulation mode 3 days a week, once a day, for a total of 9 sessions over 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 10-Meter Walk Test | Test to measure patients' functional ambulation skills. | Baseline- 3 - 6 weeks(follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Scale | Evaluation of plantar flexor muscle spasticity using the Modified Ashworth Scale (MAS). The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension. | Baseline- 3 - 6 weeks(follow up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tugba Atan | Gaziler Physical Medicine and Rehabilitation Education and Research Hospital | Principal Investigator |
| Yunus Emre Bildik | Gaziler Physical Medicine and Rehabilitation Education and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziler Physical Medicine and Rehabilitation Education and Research Hospital | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33906450 | Background | Yoldas Aslan S, Kutlay S, Dusunceli Atman E, Elhan AH, Gok H, Kucukdeveci AA. Does extracorporeal shock wave therapy decrease spasticity of ankle plantar flexor muscles in patients with stroke: A randomized controlled trial. Clin Rehabil. 2021 Oct;35(10):1442-1453. doi: 10.1177/02692155211011320. Epub 2021 Apr 28. | |
| 31827687 | Background |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Sham laser | Device | The same procedure will be followed, but sham laser will be applied at 0 j/cm2 for 10 minutes. |
|
| Joint Range of Motion (ROM) Measurement |
Passive measurement of ankle joint range of motion (ROM) with a goniometer |
| Baseline- 3 - 6 weeks(follow up) |
| Ultrasonography | Sonographic measurement of medial gastrocnemius muscle thickness | Baseline- 3 - 6 weeks(follow up) |
| Timed Up and Go test | To determine fall risk and measure the progress of balance, sit to stand and walking | Baseline- 3 - 6 weeks(follow up) |
| Stroke Specific Quality of Life Scale | It is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke. Scores range from 49-245. Higher scores indicate better functioning. | Baseline- 3 - 6 weeks(follow up) |
| Visual analogue scale for pain (VAS- pain) | Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity. | Baseline- 3 - 6 weeks(follow up) |
| Tomazoni SS, Machado CDSM, De Marchi T, Casalechi HL, Bjordal JM, de Carvalho PTC, Leal-Junior ECP. Infrared Low-Level Laser Therapy (Photobiomodulation Therapy) before Intense Progressive Running Test of High-Level Soccer Players: Effects on Functional, Muscle Damage, Inflammatory, and Oxidative Stress Markers-A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Nov 16;2019:6239058. doi: 10.1155/2019/6239058. eCollection 2019. |
| 27220527 | Background | Pekyavas NO, Baltaci G. Short-term effects of high-intensity laser therapy, manual therapy, and Kinesio taping in patients with subacromial impingement syndrome. Lasers Med Sci. 2016 Aug;31(6):1133-41. doi: 10.1007/s10103-016-1963-2. Epub 2016 May 25. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |