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

NCT02556164 | Completed DMC

• 1 other identifier: UArizona
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Keywords

Electroacupuncture; Body Worn Sensor; Gait; Balance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change of postural balance (COG) by objective measurement

  3 weeks

• Change of stride length by objective measurement

  3 weeks

• Change of postural balance (Ankle/hip sway) by objective measurement

  3 weeks

• Change of Unified Parkinson's Disease Rating Scale

  3 weeks

• Change of SF-12 health survey

  3 weeks

Study Arms (2)

Real EA

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.

Procedure: Electroacupuncture; Other: Body-worn sensor technology

Sham EA

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.

Procedure: Electroacupuncture; Other: Body-worn sensor technology

Interventions

Electroacupuncture 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.

Real EA; Sham EA

Body-worn sensor technology 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)

Real EA; Sham EA

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients who have received previous acupuncture;
• patients who have had DBS;
• 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
• patients with non-PD related gait disorders.

Sponsors & Collaborators

• University of Arizona: lead

Related Publications (1)

• 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.

  PMID: 27227460 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Bijan Najafi, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Neurology

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 22, 2015
• Study Start: May 1, 2013
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11