Effect of Transcutaneous Electrical Nerve Stimulation Applied to Acupuncture Points on Gait and Quality of Life in Stroke Patients: a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Modified Ashworth scale (MAS)
研究概览
简要总结
A study was conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients.
Thirty stroke patients from both sexes aging from 40 to 65 years were randomly assigned into two equal groups: study group and control group. The study group received TENS plus the designed physiotherapy program and the control group received only the same designed physiotherapy program. The outcome measures concerned with spasticity, gait and QoL.
详细描述
A RCT study conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients. The study was conducted at the outpatient clinic of Faculty of Physical Therapy, Cairo University and Kasr El-Ainy Hospitals, Faculty of Medicine, Cairo University, Egypt.
Forty subjects were screened for eligibility but only thirty stroke patients from both sexes aging from 40 to 65 years who were included and randomly assigned into two equal groups: study and control group. The study group received TENS plus the designed physiotherapy program and the control group received only the same designed physiotherapy program. Patients were treated three times weekly for four weeks.
The outcome measures included the Modified Ashworth Scale (MAS) for assessing spasticity, the WHOQOL-BREF scale for evaluating QoL and the Biodex Gait Trainer for measuring the gait kinematics. Evaluation of all variables took place pretreatment and post treatment.
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, Outcomes Assessor)
盲法说明
stactician
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic stroke disease (6-8- months)
- •Age 45-60 years old
- •Mild to moderate spasticity
- •Can walk 10 meters independently
- •Sufficient cognitive abilities
排除标准
- •Other neurological diseases
- •Severe spasticity
- •Cognitive impairments
- •Medical instability
- •Sever arthritis or contractures
- •Cardio-pulmonary disorders
研究组 & 干预措施
Intervention arm
TENS applied to acupuncture points in addition to physical therapy program
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Device)
Intervention arm
TENS applied to acupuncture points in addition to physical therapy program
干预措施: Physical Therapy program (Other)
control arm
only physical therapy program
干预措施: Physical Therapy program (Other)
结局指标
主要结局
Modified Ashworth scale (MAS)
时间窗: • "At baseline and at the end of treatment at 4 weeks"
Spasticity assessment scale. Score (0-4) 0 means no increase in tone. 4 means rigidity The lower the score, the lower spasticity the patient has.
World Health Organization quality of life instrument "WHOQOL-BREF"
时间窗: • ""At baseline and at the end of treatment at 4 weeks""
Quality of life assessment questionnaire. A validated Arabic version was used. 26 items The scores on the scale from 1- 5 : 1 is the lowest score while 5 is the highest score. The higher score the participants get, the better QoL they have
Biodex Gait Trainer
时间窗: • ""At baseline and at the end of treatment at 4 weeks""
A special treadmill to measure gait kinematic parameters
次要结局
未报告次要终点
研究者
Amina Awad,PhD
Associate Professor, Department of Physical Therapy for Neurology and Neurosurgery, Faculty of Physical Therapy, Cairo University
Cairo University