Investigation of the Use of Acupuncture for the Treatment of Spasticity in Chronic Stroke Participants
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in 2 minute walk test
研究概览
简要总结
The purpose of this study is to investigate if acupuncture is more effective than sham treatment in reducing lower extremity spasticity, and improving gait speed in the chronic phase of stroke recovery.
详细描述
Background: Stroke is one of the leading causes of death and disability in Canada. There are approximately 50,000 new cases every year. Stroke victims often experience decreased mobility and significant disability as a result of impaired motor control and velocity-dependent muscle hypertonus (spasticity) in the lower extremity. Over the past 25 years, there has been an increasing interest in the use of acupuncture for the management of stroke-related neurological deficits.
Research questions: Is acupuncture more effective than sham treatment in reducing lower extremity spasticity, and improving gait speed in the chronic phase of stroke recovery?
Methodology
Recruitment: Forty patients will be recruited from the out patient rehabilitation program of a university affiliated teaching hospital.
Group Assignment and Blinding:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of the patients between 55 to 70 years old
- •Time from stroke onset 12 months but less than 18 months
- •Clinical picture: symptoms of hemiparesis from ischemic or hemorrhage stroke which is confirmed with CAT scan or MRI, stable with vital signs
- •Independently ambulatory with/without a walking aid and with/without orthoses for 2 minutes
- •Exhibit spastic equinovarus hemiparesis gait on the affected side
- •Cognitive function level ≥ 23 with the total score on the MiniMental Status Examination
排除标准
- •History of more than one episode of stroke
- •Receiving Botox injections for treatment of spasticity
- •Medically unstable with life-threatening conditions, epileptic seizures, auto-immune disease, acute or chronic infectious disease
研究组 & 干预措施
Acupuncture
True acupuncture
干预措施: Acupuncture (Other)
Sham needle
Retractable acupuncture needles will be used. No true transcutaneous needling through the skin
干预措施: Sham needle (Other)
结局指标
主要结局
Change from baseline in 2 minute walk test
时间窗: Baseline to 3 weeks
Two-minute walk tests (2MWT) - Participants are required to walk continuously for 2 minutes, using their regular aids or orthoses, but with no manual support. The walk will take place over a distance of 10m, and participants will be required to change direction of their own accord. The distance walked in a 2-minute interval will be recorded
次要结局
- Change from baseline in self report ankle tightness(Baseline to 3 weeks)
- Change from baseline in ankle range of motion(Baseline to 3 weeks)