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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-05

Study Completion Date

2024-09-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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High-intensity laser therapy group

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.

Group Type ACTIVE_COMPARATOR

High-intensity laser

Intervention Type 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

Sham group

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

Group Type SHAM_COMPARATOR

Sham laser

Intervention Type DEVICE

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

Interventions

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High-intensity laser

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

Intervention Type DEVICE

Sham laser

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No