Comparison of High Intensity Laser Therapy (HILT) and Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Plantar Flexor Spasticity in Post-Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Modified Ashworth Scale (MAS)
研究概览
简要总结
Stroke is one of the leading causes of long-term disability worldwide. Spasticity (muscle spasm) is a common and disabling consequence of stroke. Lower extremity spasticity significantly compromises postural control, balance, and gait performance. Patients with spasticity demonstrate greater difficulty in standing and walking compared with non-spastic stroke survivors.
Management of spasticity includes physical therapy modalities, exercise programs, orthoses, and pharmacological agents. In recent years, novel noninvasive treatment modalities including extracorporeal shock wave therapy (ESWT), and low- and high-intensity laser therapy (HILT) have been investigated for spasticity management however, robust evidence remains limited.
ESWT is a treatment method applied by focusing high-pressure sound waves produced outside the body on the desired area of the body using a steel-tipped applicator. Patients can resume their daily activities immediately after a treatment session lasting between 5-20 minutes. Scientific researches have demonstrated that ESWT is a safe and effective modality for reducing upper and lower extremity spasticity after stroke.
HILT is a a non-invasive, advanced therapeutic approach that utilizes high-intensity laser technology to promote healing and alleviate pain. It has been widely used in musculoskeletal disorders and generally well tolerated without significant adverse effects. Previous studies suggest that laser application to spastic muscles after stroke may reduce spasticity and pain.
The present study aimed to investigate and compare the effects of ESWT and HILT applied to the calf muscles on spasticity and functional gait parameters only with clinical examination methods in patients with stroke.
详细描述
Stroke is defined as an acute episode of focal dysfunction of the brain, retina, or spinal cord lasting longer than 24 hours, or of any duration if imaging or autopsy demonstrates focal infarction or hemorrhage relevant to the symptoms.
Stroke is one of the leading causes of mortality, long-term disability, and socioeconomic burden worldwide. Although approximately 88% of patients survive a stroke, a substantial proportion experience persistent impairments that limit independent living and participation in daily activities.
Spasticity is a common and disabling consequence of stroke and is defined as a motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes resulting from abnormal intra-spinal processing of primary afferent input. It arises from impaired reflex modulation and leads to secondary changes in muscle tissue such as increased stiffness, fibrosis, and muscle atrophy. Post-stroke spasticity affects approximately 30% of patients and may develop at variable time points following stroke onset.
Lower extremity spasticity significantly compromises postural control, balance, and gait performance. Patients with spasticity demonstrate greater difficulty in standing and walking compared with non-spastic stroke survivors. Among lower limb muscles, the gastrocnemius medialis is most frequently affected, and its involvement is strongly associated with impaired gait mechanics and reduced walking efficiency.
Management of spasticity includes physical therapy modalities, comprehensive neurorehabilitation programs, orthoses, pharmacological agents, and surgical interventions. Stretching exercises constitute the cornerstone of rehabilitation, aiming to improve the viscoelastic properties of the muscle-tendon unit and prevent fixed contractures.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever stroke;
- •At least 3 months elapsed since stroke onset;
- •Age ≥18 years;
- •Presence of ankle plantar flexor spasticity graded 1-3 on the Modified Ashworth Scale (MAS);
- •Ability to ambulate independently or under supervision with or without assistive devices/orthoses;
- •Sufficient cognitive capacity to understand and follow test instructions
排除标准
- •Fixed ankle contracture (peak ankle dorsiflexion <0° with the knee in extension);
- •Current use of antispastic medications or a history of botulinum toxin injection within the previous 4 months;
- •Any orthopedic, rheumatologic, neurologic, cardiovascular, or visual comorbidity other than stroke that could affect gait;
- •Insufficient cognitive function.
研究组 & 干预措施
Rehabilitation-only group
All participants received a standardized rehabilitation program consisting of 1-hour sessions, 5 days per week, for 3 consecutive weeks. The program included:
- Range of motion and stretching exercises targeting the hamstrings, rectus femoris, and ankle plantar flexors;
- Strengthening exercises for hip flexors, hip extensors, knee extensors, hamstrings, ankle plantar flexors, and trunk muscles;
- Gait training, postural exercises, balance training, transfer training, and endurance exercises, all performed under the supervision of a physiotherapist.
干预措施: Rehabilitation Protocol (Procedure)
ESWT plus rehabilitation group
Participants in the ESWT group received ESWT once weekly for 3 consecutive weeks (total of 3 sessions), in addition to the rehabilitation program. ESWT was applied to the gastrocnemius muscle belly in the prone position using a Starz Medical Masterpuls MP100 device, with the following parameters: frequency 5 Hz, energy flux density 0.340 mJ/mm², 2000 pulses, and a 15-mm applicator.
干预措施: Extracorporeal Shock Wave Therapy (ESWT) (Device)
HILT plus rehabilitation group
In addition to the rehabilitation program, participants in the HILT group received HILT three times per week for 3 consecutive weeks (total of 9 sessions). Each session lasted 4 minutes. HILT was applied to the gastrocnemius muscle belly in the prone position using longitudinal movements, with an energy density of 50 J/cm² and output power of 5 W in biostimulatory mode, using a BTL-6000 High-Intensity Laser device.
干预措施: High-Intensity Laser Therapy (HILT) (Device)
结局指标
主要结局
Modified Ashworth Scale (MAS)
时间窗: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Plantar flexor spasticity was assessed using the Modified Ashworth Scale (MAS), a widely used clinical instrument for evaluating resistance to passive movement. The MAS is employed to quantify increases in muscle tone and grades spasticity on an ordinal scale ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates rigidity of the affected limb in flexion or extension.
次要结局
- Ankle Range of Motion (ROM)(Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).)
- Fugl-Meyer Lower Extremity Assessment (FM-LE)(Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).)
- Timed Up and Go Test (TUG)(Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).)
- 10-Meter Walk Test(Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).)
- Berg Balance Scale (BBS)(Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).)
研究者
SAMİ KÜÇÜKŞEN
Professor
Necmettin Erbakan University