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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556164
• Other study ID #: UArizona
• Status: Completed
• Phase: N/A
• First received: September 8, 2015
• Last updated: November 8, 2017
• Start date: May 2013
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2017
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change of SF-12 health survey	SF-12 health survey (MCS, PCS)	3 weeks
Secondary	Change of Short Falls Efficacy Scale-International	(Short FES-I, 7-28)	3 weeks
Secondary	Change of the visual analog scale	the visual analog scale (VAS, 0-10) for pain,	3 weeks
Secondary	Potential adverse events related to acupuncture	measured by Adverse Events Report Related to Acupuncture	Baseline, 1 week, 2 week and 3 weeks.