A prospective, randomized, comparative, parallel, 2- arm study to evaluate the efficacy and safety of a Myostaal liniment application as add on therapy for the reduction of spasticity in patients suffering from Hemiplegia.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Improvement in muscle strength assessed on basis of “Tardieu Scale†to assess the spasticity, Goniometer to assess the Range of movement of affected shoulder joint, elbow joint and wrist joint
研究概览
简要总结
Stroke is the second leading cause of death amongst the persons above 60years of age, the fifth leading cause of death among 15-59 years old population and the leading cause of disability worldwide.
According to WHO 15 million people suffer from stroke worldwide each year (WHO 2002).
In India stroke prevalence rate 84-262/100000 in rural; 334-424/100000 in urban area. Mid cerebral artery is the most common vascular lesion in cerebro vascular accidents.
In stroke when the injured area of brain controls Muscle tone, spasticity occurs. Effect of spasticity includes Stiff fingers, arm or legs affecting function of the muscles and mobility of joints. Each person of stroke requires a comprehensive rehabilitation programme to help them regain their quality of life; this involves a multidisciplinary team approach with inputs from physician, physiotherapists. Physiotherapy enables people to relearn lost abilities and regain independence. Massage therapy aims to prevent stiffness of affected limbs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient of either sex in the age group of 30-70 years.
- •2.Diagnosed case of Hemiplegia who is stable after onset up to 01 year.
- •3.Patients willing to give written informed consent.
- •4.Patients willing to follow up.
排除标准
- •Subject Exclusion Criteria:
- •Comatose patients.
- •Patient on : (a) oral multi-vitamin therapy within the previous 07 days, or (b) intramuscular multiviatmins within 07 days, or (c) Oral protein suppliments which claims to enhance the muscle power, or (d) topical corticosteroid at the site of application within 14 days; Or patient requiring systemic corticosteroids during the course of study.
- •(e) Patients on NSAIDS use will be excluded
- •Patient who has undergone cranial surgery or who is planning to undergo surgery in next 1 month will be excluded from the study.
- •Patients suffering from cerebral and cerebellar atrophy due to infectious diseases like encephalitis.
- •Patient with space occupying lesions and known case of Epilepsy.
- •Patients with auto-immune disease, uncontrolled hypertension,
- •Diabetes mellitus requiring insulin injections, chronic severe respiratory disease and severe active infectious disease requiring hospitalization.
- •Patient with history of any other systemic illness, life threatening cardiovascular and other progressive neurological diseases.
- •Patient participating in another investigational drug trial in the previous 30 days.
- •Patients who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
- •History of HIV, Hepatitis B or any immune deficient conditions.
结局指标
主要结局
Improvement in muscle strength assessed on basis of “Tardieu Scale†to assess the spasticity, Goniometer to assess the Range of movement of affected shoulder joint, elbow joint and wrist joint
时间窗: at baseline, 15 days, at the end of 30 days
次要结局
- Patient’s Global safety assessment score(at baseline, 15 days, 30 days)
- Adverse events recording(at baseline, 15 days, at the end of 30 days)