Clinical trial NCT02556164: Electro-acupuncture for Gait and Balance in Parkinson's Disease
Official title: Objective Assessment of Electro-acupuncture Efficacy for Gait and Balance in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Electroacupuncture
Body Worn Sensor
Gait
Balance
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of gait speed by objective measurement
timeFrame: 3 weeks
Secondary outcomes:
measure: Change of postural balance (COG) by objective measurement
timeFrame: 3 weeks
measure: Change of stride length by objective measurement
timeFrame: 3 weeks
measure: Change of postural balance (Ankle/hip sway) by objective measurement
timeFrame: 3 weeks
measure: Change of Unified Parkinson's Disease Rating Scale
timeFrame: 3 weeks
measure: Change of SF-12 health survey
timeFrame: 3 weeks
measure: Change of Short Falls Efficacy Scale-International
timeFrame: 3 weeks
measure: Change of the visual analog scale
timeFrame: 3 weeks
measure: Potential adverse events related to acupuncture
timeFrame: Baseline, 1 week, 2 week and 3 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: University of Arizona
name: Bijan Najafi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.