Investigation of the Use of Acupuncture for the Treatment of Spasticity in Chronic Stroke Participants (HHSCSTROKEAC)
研究概览
详细说明
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:
The study design is a randomized double blind format. Once identified, interested patients will be screened for eligibility by an intake secretary and randomly assigned to sham (n=20) or acupuncture treatment (n=20) groups using a computer random-number-generation system. Sealed envelopes containing the group assignment will be delivered to acupuncture-trained therapists delivering sham or true acupuncture treatment. Treating therapists' interactions will be standardized to minimize therapist/participant interaction bias Treating therapists will remain blinded to outcome assessment results. Patients will be blinded to the receipt of true acupuncture or sham needles. Outcome measurements will be done by a single assessor who is blinded to the group assignment.
Intervention: Subjects will attend 4 acupuncture treatments sessions within a 3 week period. Needles will be applied to the following acupuncture points: Jiao's foot motor sensory scalp points (2 in total) and 2 additional standardized acupuncture points in the lower legs bilaterally based on Traditional Chinese Medicine (TCM) approach. Treatment needles are pre-sterilized single disposable type, 0.20 mm size and 40 mm in length. The locations of the acupuncture point will be cleaned with alcohol (99%) swab. Needles will be left in place for 20 minutes. In the true acupuncture group, needles will be inserted to a depth at which participants report a tingling sensation (as described De-qi in TCM approach). Subjects randomized to the control group will be treated with retractable needles to avoid transcutaneous insertion at the same acupuncture points.
Outcome Measures: The following outcome measures will be assessed by a blinded assessor. Primary outcome measures:2-minute walk test. Secondary outcome measures: ankle range of motion and self report soft tissue tightness. The outcome measures time frame is set at from baseline to the completion of the intervention period at 3 weeks.
Analysis: Descriptive statistics including mean, standard deviation and frequencies will be used to describe the study participants, as appropriate. Paired t-test will be used for the parametric variables, number of steps per minute, distance on a 2-minute walk test and dorsi-flexion range of motion. Significance is set at p smaller than 0.05. All statistical analysis will be two sided and performed with SPSS (V21).
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Patricia Hoover, PhD
- 电话号码:42097 905-389-4411
- 邮箱:hoover@hhsc.ca
学习地点
-
-
Ontario
-
Hamilton、Ontario、加拿大、L8L 8E7
- 招聘中
- Hamilton Health Sciences
-
接触:
- Enoch K Ho, MPh
- 电话号码:42097 905-389-4411
- 邮箱:hoenoch@hhsc.ca
-
首席研究员:
- Enoch K Ho, MPh
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Acupuncture
True acupuncture
|
Single disposal needle to be used, 0.02 mm x 25 mm in length
|
假比较器:Sham needle
Retractable acupuncture needles will be used.
No true transcutaneous needling through the skin
|
Retractable needle with no skin puncture
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change from baseline in 2 minute walk test
大体时间: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
|
Baseline to 3 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change from baseline in self report ankle tightness
大体时间:Baseline to 3 weeks
|
Participant report outcome measure (PROM) - ankle tightness - a self report outcome measures has been widely used for pain in a format of a 10-point visual analog scale (VAS).
Recent studies showed the reliability of the adaption of PROM to cover other clinical outcomes and the re is extensive discussion on minimal detectable clinical improvement.
Ankle tightness in Achilles tendon will be recorded as a PROM on a 10-point scale with 0 being no tightness and 10 is the most.
|
Baseline to 3 weeks
|
Change from baseline in ankle range of motion
大体时间:Baseline to 3 weeks
|
Participant in sitting position, active and passive ankle dorsi-flexion will be measured by a goniometer
|
Baseline to 3 weeks
|
合作者和调查者
调查人员
- 首席研究员:Enoch K Ho, MPh、Hamilton Health Sciences Corporation
出版物和有用的链接
一般刊物
- Wu P, Mills E, Moher D, Seely D. Acupuncture in poststroke rehabilitation: a systematic review and meta-analysis of randomized trials. Stroke. 2010 Apr;41(4):e171-9. doi: 10.1161/STROKEAHA.109.573576. Epub 2010 Feb 18.
- Zhong C, Bai L, Dai R, Xue T, Wang H, Feng Y, Liu Z, You Y, Chen S, Tian J. Modulatory effects of acupuncture on resting-state networks: a functional MRI study combining independent component analysis and multivariate Granger causality analysis. J Magn Reson Imaging. 2012 Mar;35(3):572-81. doi: 10.1002/jmri.22887. Epub 2011 Nov 8.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.