Electro-acupuncture for Gait and Balance in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Objective Assessment of Electro-acupuncture Efficacy for Gait and Balance in Patients With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Procedure: Electroacupuncture
* Other: Body-worn sensor technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real EA<br>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. | Procedure: Electroacupuncture<br>* Acupuncture is an alternative medicine methodology that treats patient by various techniques including inserting small, thin needles at specific points of body. Electroacupuncture (EA), like the name implies, combines classical acupuncture and low electric current running through the needles, which are often used to enhance a treatment.<br>Other: Body-worn sensor technology<br>* Three-dimensional acceleration and angular velocity of shanks, thighs and the trunk were measured using wearable sensors each included a triaxial accelerometer and a triaxial gyroscope (LEGSys™ and BalanSens™ - BioSensics, Boston, MA)<br>|
| Sham Comparator: Sham EA<br>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. | Procedure: Electroacupuncture<br>* Acupuncture is an alternative medicine methodology that treats patient by various techniques including inserting small, thin needles at specific points of body. Electroacupuncture (EA), like the name implies, combines classical acupuncture and low electric current running through the needles, which are often used to enhance a treatment.<br>Other: Body-worn sensor technology<br>* Three-dimensional acceleration and angular velocity of shanks, thighs and the trunk were measured using wearable sensors each included a triaxial accelerometer and a triaxial gyroscope (LEGSys™ and BalanSens™ - BioSensics, Boston, MA)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of gait speed by objective measurement | 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. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of postural balance (COG) by objective measurement | Each participant performs 30-second trials of balance assessment with eyes open or closed. Center of gravity (COG, cm) is assessed using body-worn sensor technology. | 3 weeks | 
| Change of stride length by objective measurement | Participant performs two tests of normal gait (> 25 steps) under single task and dual task conditions. Stride length (m) is assessed using body-worn sensor technology. | 3 weeks | 
| Change of postural balance (Ankle/hip sway) by objective measurement | Each participant performs 30-second trials of balance assessment with eyes open or closed. Ankle sway (deg2), Hip sway (deg2), Ankle/hip sway is assessed using body-worn sensor technology. | 3 weeks | 
| Change of Unified Parkinson's Disease Rating Scale | Unified Parkinson's disease rating scale (UPDRS) is utilized. Parts I: to assess mentation, behavior and mood (0-16); Part II: to assess activities of daily living ( 0-52); Part III to motor assessment (0-104) | 3 weeks | 
| Change of SF-12 health survey | SF-12 health survey (MCS, PCS) | 3 weeks | 
| Change of Short Falls Efficacy Scale-International | (Short FES-I, 7-28) | 3 weeks | 
| Change of the visual analog scale | the visual analog scale (VAS, 0-10) for pain, | 3 weeks | 
| Potential adverse events related to acupuncture | measured by Adverse Events Report Related to Acupuncture | Baseline, 1 week, 2 week and 3 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electroacupuncture, Body Worn Sensor, Gait, Balance