The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 10-Meter Walk Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >
- •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
排除标准
- •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
结局指标
主要结局
10-Meter Walk Test
时间窗: Baseline- 3 - 6 weeks(follow up)
Test to measure patients\&amp;amp;#39; functional ambulation skills.
次要结局
- Modified Ashworth Scale(Baseline- 3 - 6 weeks(follow up))
- Joint Range of Motion (ROM) Measurement(Baseline- 3 - 6 weeks(follow up))
- Ultrasonography(Baseline- 3 - 6 weeks(follow up))
- Timed Up and Go test(Baseline- 3 - 6 weeks(follow up))
- Stroke Specific Quality of Life Scale(Baseline- 3 - 6 weeks(follow up))
- Visual analogue scale for pain (VAS- pain)(Baseline- 3 - 6 weeks(follow up))
研究者
Tuğba Atan, MD
Associate Professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital