Effect of Extracorporeal Shock Wave Therapy Applied After Botulinum Toxin Injection on Ankle Plantar Flexor Spasticity in Stroke Patients: Placebo-controlled Double-blind Study.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 10m walking test
研究概览
简要总结
Stroke is the second most common cause of death and the third most important cause of disability worldwide, with an annual death rate of 5.5 million. Spasticity is a common condition in stroke patients and has a negative impact on daily living activities. BTX-A has been successfully used in the treatment of spasticity in patients with stroke. ESWT is a physical therapy method applying high intensity pressure waves.
ESWT has been increasingly used in the management of spasticity as a safe and effective method, but the literature about ESWT in spasticity is heterogeneous and the treatment protocols are not very clear about the number of applications.
The aim of this study is to determine the effects of rESWT treatment on ankle plantar flexors spasticity applied after BTX-A injection.
详细描述
In this double-blind randomized placebo-controlled trial, 45 patient (aged 18-75) diagnosed as stroke with appropriate criteria will be included.
Patients who meet the inclusion criteria for the study will be seperated into three groups with the randomizer.org randomization program.
Group I: A single session of rESWT will be applied on the same day after BTX-A injection.
Group II: A total of 2 sessions of rESWT will be applied on the same day after BTX-A injection and on the 7th day after BTX-A injection.
Group III: A single session of placebo rESWT will be applied after BTX-A injection.
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
- Double (Participant, 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
- •Having an ischemic or hemorrhagic stroke, in subacute or chronic phase,
- •Patients with ankle plantar flexor spasticity MAS score > 1 and patients who received BTX-A injection due to spasticity
- •Stroke history of at least 3 months
排除标准
- •History of neuromuscular disease
- •Compared to the unaffected side; More than 50% reduction in dorsiflexion range of motion of the affected side
- •Dynamic ankle contracture
- •Affected side lower extremity surgery in the last 12 months
- •Having Botox or phenol application to the affected gastrocnemius in the last 3 months
- •Change in the dose of antispastic medication used in the last 3 months
- •Infection/wound in the affected lower extremity
- •Contraindications for ESWT (pregnancy, cancer, bleeding disorders, inflammatory disease, pacemakers or other electronic implants).
- •Significant muscle atrophy or fibrosis of the target muscle (Heckmatt scale III and IV)
结局指标
主要结局
10m walking test
时间窗: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Subjects are asked to walk at maximum speed in a 10-meter corridor. The time it takes them to complete the distance is measured in seconds with a stopwatch. The measurement is repeated three times and the average time of the three measurements is recorded.
Timed Up and Go Test
时间窗: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
The person is asked to get up from the chair, walk 3 meters at a safe and normal pace, turn, walk back and sit on the chair, and the time is recorded in seconds.
Patient Evaluation Form
时间窗: BEFORE TREATMENT
Demographic information, stroke history, and medications used by all stroke patients included in the study will be recorded.
Barthel Activities of Daily Living Index
时间窗: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
It is used to measure the independence of the individual in daily living activities.
Modified Ashworth Scale (MAS)
时间窗: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
It is a method used to determine the severity of spasticity. It is based on the subjective rating of the resistance felt during the examination Modified Ashworth Scale is graded between 0 and 4 points. 0: No increase in muscle tone, 4: affected part is rigid in flexion or extension. It means that the higher the score the patient receives, the higher the degree of spasticity.
Modified Tardieu Scale (MTS)
时间窗: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
The severity of muscle tone is evaluated at different determined speeds. The first angle at which an increase in resistance is detected in the joint is recorded. The range of motion is compared with the angle at completion.The minimum value in evaluating the joint angle is 0 degrees.The maximum value varies depending on the patient's joint.Higher angle value means worse result. Modified Tardieu Scale is rated between 0 and 5 points. 0: no resistance during passive motion, 5: The joint can not be moved. It means that the higher the score the patient receives, the higher the degree of spasticity.
Timed sit and stand test
时间窗: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
It is a test that evaluates the patient's sit-to-stand activity, lower extremity strength and dynamic balance. The number of times the patient sits and stands up within 30 seconds gives the test score.
Functional Ambulation Scale
时间窗: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
It classifies individuals between 0 and 5 according to the basic motor skills required for functional ambulation.
次要结局
- Brunnstrom Staging(BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT)
- Visual Analog Scale (VAS)(BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT)
研究者
Zeynep Selimoğlu Ayneli
Lecturer PHD
Saglik Bilimleri Universitesi