Clinical trial NCT06357949: The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke Patients
Official title: The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 and ≤ 75 years
* Patients experiencing their first stroke (onset \> 3 months)
* Patients with ankle plantar flexor muscle spasticity with a Modified Ashworth Scale (MAS) score ≥ 1 and \< 4
* Lower extremity Brunnstrom staging ≥ 3
* Patients describing pain complaints in the affected leg as VAS \> 3.
* Patients who can stand independently or with supervision for at least 2 minutes for measurements taken while standing
* Patients who can walk independently or with/without assistive devices for at least 10 meters for measurements taken while walking
* Patients with cognitive abilities sufficient to understand the study instructions (Mini-Mental State Examination score \> 23)
* Patients with stable medical and psychological conditions
* Patients willing to participate in the study

Exclusion Criteria:

* Patients with severe cardiovascular or musculoskeletal problems that impair walking (e.g., fixed ankle contracture)
* Patients who have been treated for spasticity with botulinum toxin, phenol, or alcohol injections in the past 6 months
* Patients who have undergone antispastic surgery in the treatment area in the past 6 months
* Patients with recent changes in oral antispastic medication use in the past 6 months
* Patients with acute inflammation or active infection in the treatment area
* Patients with a history of ankle joint contracture, fracture, neoplasm, vascular disease, etc.
* Patients with other neurological (Parkinson's disease, epilepsy, meningitis, cerebellar disease, vertigo, dizziness, polyneuropathy, etc.) or musculoskeletal (severe back pain, knee problems) diseases that could affect balance performance other than stroke
* Patients with severe vision, hearing, and language problems
* Patients who do not consent to participate in the study

Primary outcomes:
measure: 10-Meter Walk Test
timeFrame: Baseline- 3 - 6 weeks(follow up)
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: Baseline- 3 - 6 weeks(follow up)
measure: Joint Range of Motion (ROM) Measurement
timeFrame: Baseline- 3 - 6 weeks(follow up)
measure: Ultrasonography
timeFrame: Baseline- 3 - 6 weeks(follow up)
measure: Timed Up and Go test
timeFrame: Baseline- 3 - 6 weeks(follow up)
measure: Stroke Specific Quality of Life Scale
timeFrame: Baseline- 3 - 6 weeks(follow up)
measure: Visual analogue scale for pain (VAS- pain)
timeFrame: Baseline- 3 - 6 weeks(follow up)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Tugba Atan
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Yunus Emre Bildik
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.