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

NCT ID: NCT02556164

Last Updated: 2017-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-06-30

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.

Conditions

Parkinson's Disease

Keywords

Electroacupuncture; Body Worn Sensor; Gait; Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: PROCEDURE

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

Intervention Type: OTHER

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 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.

Group Type: SHAM_COMPARATOR

Electroacupuncture

Intervention Type: PROCEDURE

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

Intervention Type: OTHER

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)

Interventions

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.

Intervention Type: PROCEDURE

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)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Hong Lei

Associate Professor of Clinical Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bijan Najafi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

References

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.

Reference Type: DERIVED

PMID: 27227460 (View on PubMed)

Other Identifiers

UArizona

Identifier Type: -

Identifier Source: org_study_id