Objective Assessment of Electro-acupuncture Efficacy for Gait and Balance in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Change of gait speed by objective measurement
研究概览
简要总结
Gait and balance disorders, key contributors to fall and poor quality of life, represent a major therapeutic challenge in Parkinson's disease (PD). Despite the widespread use of acupuncture in recent years in PD, its efficacy remains unclear, largely due to methodological flaws and lack of high quality studies using objective outcome measures. In a patient and assessor-blind pilot study, investigators objectively assess the efficacy of electroacupuncture (EA) for gait and balance disorders using body-worn sensor technology in patients with PD.
详细描述
In this study, investigators employee objective innovative body-worn sensor technologies to assess potential mobility-associated outcomes of PD. Investigators compare acute changes in gait and balance that occurred after repeated administration of two interventions: A specific real EA and a sham EA. The design of the experiments uses a control that accounts for both placebo and possible some active components of a generalized needle-insertion-based procedure. By using a sham control, the investigators were able to more fully test whether the specific EA intervention could lead to changes in objective gait and balance parameters, or subjective self-reported improvements that are beyond placebo induced effects and the natural course of the disease.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling men or women ages 55 years or older with diagnosis of PD;
- •patients who have the ability to walk 20meters without walking assistance; and
- •patients who are stable without anti-PD medication(s) change for at least 1 month. The PD diagnosis was made by movement disorder specialists based on the UK Brain Bank criteria and supported by DaTscan (Ioflupane I 123 injection) when possible.
排除标准
- •patients who have received previous acupuncture;
- •patients who have had DBS;
- •patients with any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study; and
- •patients with non-PD related gait disorders.
研究组 & 干预措施
Real EA
Real EA as intervention is performed at the selected standard acupuncture points and "De-qi" is achieved with needle manipulation before electric stimulation is delivered.
干预措施: Electroacupuncture (Procedure)
Real EA
Real EA as intervention is performed at the selected standard acupuncture points and "De-qi" is achieved with needle manipulation before electric stimulation is delivered.
干预措施: Body-worn sensor technology (Other)
Sham EA
Sham EA as intervention is performed for the control group at non-acupuncture points without needle manipulation. The electric stimulation in sham acupuncture was performed in a similar fashion to the real EA.
干预措施: Electroacupuncture (Procedure)
Sham EA
Sham EA as intervention is performed for the control group at non-acupuncture points without needle manipulation. The electric stimulation in sham acupuncture was performed in a similar fashion to the real EA.
干预措施: Body-worn sensor technology (Other)
结局指标
主要结局
Change of gait speed by objective measurement
时间窗: 3 weeks
Participant performs two tests of normal gait (\> 25 steps) under single task and dual task conditions. Gait speed (m/s) is assessed using body-worn sensor technology.
次要结局
- Change of postural balance (COG) by objective measurement(3 weeks)
- Change of stride length by objective measurement(3 weeks)
- Change of postural balance (Ankle/hip sway) by objective measurement(3 weeks)
- Change of Unified Parkinson's Disease Rating Scale(3 weeks)
- Change of SF-12 health survey(3 weeks)
- Change of Short Falls Efficacy Scale-International(3 weeks)
- Change of the visual analog scale(3 weeks)
- Potential adverse events related to acupuncture(Baseline, 1 week, 2 week and 3 weeks.)
研究者
Hong Lei
Associate Professor of Clinical Neurology
University of Arizona