The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke Patients
- Conditions
- Stroke
- Interventions
- Device: High-intensity laserDevice: Sham laser
- Registration Number
- NCT06357949
- Lead Sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-intensity laser therapy group High-intensity laser 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. Sham group Sham laser The same procedure will be followed, but sham laser will be applied at 0 j/cm2 for 10 minutes.
- Primary Outcome Measures
Name Time Method 10-Meter Walk Test Baseline- 3 - 6 weeks(follow up) Test to measure patients\&amp;amp;#39; functional ambulation skills.
- Secondary Outcome Measures
Name Time Method Modified Ashworth Scale Baseline- 3 - 6 weeks(follow up) 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.
Joint Range of Motion (ROM) Measurement Baseline- 3 - 6 weeks(follow up) Passive measurement of ankle joint range of motion (ROM) with a goniometer
Ultrasonography Baseline- 3 - 6 weeks(follow up) Sonographic measurement of medial gastrocnemius muscle thickness
Timed Up and Go test Baseline- 3 - 6 weeks(follow up) To determine fall risk and measure the progress of balance, sit to stand and walking
Stroke Specific Quality of Life Scale Baseline- 3 - 6 weeks(follow up) 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.Visual analogue scale for pain (VAS- pain) Baseline- 3 - 6 weeks(follow up) 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.
Trial Locations
- Locations (1)
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
🇹🇷Ankara, Turkey