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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Procedure: Electroacupuncture; Other: Body-worn sensor technology

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Community-dwelling men or women ages 55 years or older with diagnosis of PD;
2. patients who have the ability to walk 20meters without walking assistance; and
3. 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:

1. patients who have received previous acupuncture;
2. patients who have had DBS;
3. 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
4. patients with non-PD related gait disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: Electroacupuncture; 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.; Other: Body-worn sensor technology; 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)
SHAM_COMPARATOR: 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.	Procedure: Electroacupuncture; 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.; Other: Body-worn sensor technology; 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)

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.

Collaborators and Investigators

• Sponsor: University of Arizona

Publications and helpful links

General Publications

• Lei H, Toosizadeh N, Schwenk M, Sherman S, Karp S, Sternberg E, Najafi B. A Pilot Clinical Trial to Objectively Assess the Efficacy of Electroacupuncture on Gait in Patients with Parkinson's Disease Using Body Worn Sensors. PLoS One. 2016 May 26;11(5):e0155613. doi: 10.1371/journal.pone.0155613. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): June 30, 2016
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (ESTIMATE): September 22, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Balance; Gait; Electroacupuncture; Body Worn Sensor
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: UArizona