The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke Patients

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Completed

Conditions: Stroke

Treatments: Device: High-intensity laser; Device: Sham laser

Study type: Interventional

Funder types: Other

Identifiers

NCT06357949

E2-23-3615

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

High-intensity laser therapy group

Active Comparator group

Description:

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.

Treatment:

Device: High-intensity laser

Sham group

Sham Comparator group

Description:

The same procedure will be followed, but sham laser will be applied at 0 j/cm2 for 10 minutes.

Treatment:

Device: Sham laser