Effect of Cooling Vest on Fatigue and Spatiotemporal Gait Parameters in Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- fatigue
研究概览
简要总结
This study is prospective, randomized controlled trail that will be conducted to investigate the effect of cooling therapy on fatigue and gait in patient with multiple sclerosis(MS).
详细描述
Thirty patients from both sexes will be enrolled in this study. They will be assigned into two equal groups (study and control groups). Patients will be diagnosed as MS patients based on careful clinical evaluation by the neurologist and magnetic resonance imaging (MRI) of the brain. The patients will be recruited from the faculty of Physical Therapy, Cairo University, and El Kasr El Ainy hospitals.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thirty MS patients of both sexes.
- •Age of patients ranges from 20 to 40 years.
- •NOT less than 8 months since Symptoms onset.
- •The body mass index ranged (BMI) from 20 - 24.5 Kg/m2 .
- •The grade of The muscle tone of the affected limbs muscles ranged from 1
- •to 2 grade according to Modified Ashower scale of muscle tone
- •All the patients are medically stable.
- •Patients have intact sensations (deep & superficial).
排除标准
- •Other neurological and orthopedic impairments in upper or lower limb.
- •Having visual and hearing problems.
- •Inability to sit independently on a chair.
- •Impaired cognition and impaired comprehension and ideomotor apraxia.
- •History of endogenous depression or severe psychiatric disorders.
- •Severe neglect, and major medical problems or comorbidities that will influence upper or lower extremity usage or cause severe pain.
结局指标
主要结局
fatigue
时间窗: At baseline and re assessed 6 weeks later.
assessed by Fatigue Severity Scale(FSS): FSS is designed to measure fatigue in a single dimension using the nine items, which represent a single scale. Each FSS item consists of statements that are scored on a seven-point Likert type scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The mean of the nine item scores is used as the FSS score, which ranges from 1 to 7. However, some studies have calculated an FSS score as the sum of all nine items, ranging from 9 to 63.The unit of measurement is points.
gait parameter (Gait Speed)
时间窗: At baseline and re assessed 6 weeks later.
kinovea software used for assessment: • The unit of measurement for gait speed is meter/second (m/sec)
gait parameters: Stride Length and Stride Length
时间窗: At baseline and re assessed 6 weeks later.
kinovea software used for assessment: • The unit of measurement for Stride Length and Stride Length is centimeter (cm)
gait parameter (Double Support)
时间窗: At baseline and re assessed 6 weeks later.
kinovea software used for assessment: • The unit of measurement for Double Support is seconds (sec)
次要结局
- functional capacity(At baseline and re assessed 6 weeks later.)
研究者
Mina Khalil essa ibrahim
Demonstrator
Cairo University