Overview

This trial is active, not recruiting.

Condition parkinson's disease
Treatments electroacupuncture, body-worn sensor technology
Sponsor University of Arizona
Start date May 2013
End date May 2016
Trial size 30 participants
Trial identifier NCT02556164, UArizona

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
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.
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 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.
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.
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)

Primary Outcomes

Measure
Change of gait speed by objective measurement
time frame: 3 weeks

Secondary Outcomes

Measure
Change of postural balance (COG) by objective measurement
time frame: 3 weeks
Change of stride length by objective measurement
time frame: 3 weeks
Change of postural balance (Ankle/hip sway) by objective measurement
time frame: 3 weeks
Change of Unified Parkinson's Disease Rating Scale
time frame: 3 weeks
Change of SF-12 health survey
time frame: 3 weeks
Change of Short Falls Efficacy Scale-International
time frame: 3 weeks
Change of the visual analog scale
time frame: 3 weeks
Potential adverse events related to acupuncture
time frame: Baseline, 1 week, 2 week and 3 weeks.

Eligibility Criteria

Male or female participants at least 55 years old.

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.

Additional Information

Official title Objective Assessment of Electro-acupuncture Efficacy for Gait and Balance in Patients With Parkinson's Disease
Principal investigator Bijan Najafi, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of Arizona.