Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease: A Single Blinded Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Balance function evaluation
研究概览
简要总结
This plan is to evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for PD patients. This is a randomized, controlled, single-blind clinical trial.
详细描述
BACKGROUND: Parkinson's disease (PD) is an age-related progressive neurodegenerative disease. The etiology and pathogenetic mechanisms that cause PD are still not fully understood. Scalp acupuncture (SA), a common treatment modality within complementary and alternative medicine, has been widely used for PD.
OBJECTIVE: To evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for PD patients.
DESIGN: Randomized, controlled, single-blind clinical trial. SETTING: Department of Neurology, Chang Bing Show Chwan Memorial Hospital in Changhua County.
PARTICIPANTS: Patients with PD of grade 1 to 3 of Hoehn & Yahr (H&Y) scale (N = 26).
INTERVENTIONS: SA group (Si Shen Cong and Baihui) or control group. The techniques were administered by traditional chinese medicine trained in SA and evaluated at baseline and at 20 and 30 minutes.
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)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 50-75
- •Meet the diagnostic criteria of Parkinson's disease: UK (United Kingdom) Parkinson's disease society brain bank clinical diagnostic criteria
- •Disease severity of Hoehn-Yahr stage: stage I to III
- •clinical condition stable, not adjusting medicine in recent 3 months
- •no falling episode in recent 1 year
- •live independently
排除标准
- •already enrolled in another studies
- •can't cooperate this evaluation examinations due to poor visual acuity, impaired cognitive function, musculoskeletal system disorder, or psychiatric illness
- •any other condition would make participants not to cooperative this study
- •can't tolerate acupuncture procedure
研究组 & 干预措施
acupuncture with "De Qi"
all participants in this group will receive the standard procedure of acupuncture.
干预措施: Acupuncture (Procedure)
Sham acupuncture
In this group, all participants will receive acupuncture needle insertion but not exact acupoint's location and depth.
干预措施: Needle Insertion (Procedure)
结局指标
主要结局
Balance function evaluation
时间窗: 15-20 minutes
check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)
次要结局
- Motor function evaluation(15-20 minutes)