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

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ClinicalTrials.gov Identifier: NCT02556164
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hong Lei, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Procedure: Electroacupuncture Other: Body-worn sensor technology Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Objective Assessment of Electro-acupuncture Efficacy for Gait and Balance in Patients With Parkinson's Disease
Study Start Date : May 2013
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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)

Sham Comparator: 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.
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)




Primary Outcome Measures :
  1. Change of gait speed by objective measurement [ Time Frame: 3 weeks ]
    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.


Secondary Outcome Measures :
  1. Change of postural balance (COG) by objective measurement [ Time Frame: 3 weeks ]
    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.

  2. Change of stride length by objective measurement [ Time Frame: 3 weeks ]
    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. Change of postural balance (Ankle/hip sway) by objective measurement [ Time Frame: 3 weeks ]
    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.

  4. Change of Unified Parkinson's Disease Rating Scale [ Time Frame: 3 weeks ]
    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)

  5. Change of SF-12 health survey [ Time Frame: 3 weeks ]
    SF-12 health survey (MCS, PCS)

  6. Change of Short Falls Efficacy Scale-International [ Time Frame: 3 weeks ]
    (Short FES-I, 7-28)

  7. Change of the visual analog scale [ Time Frame: 3 weeks ]
    the visual analog scale (VAS, 0-10) for pain,

  8. Potential adverse events related to acupuncture [ Time Frame: Baseline, 1 week, 2 week and 3 weeks. ]
    measured by Adverse Events Report Related to Acupuncture



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556164


Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Bijan Najafi, PhD University of Arizona
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hong Lei, Associate Professor of Clinical Neurology, University of Arizona
ClinicalTrials.gov Identifier: NCT02556164    
Other Study ID Numbers: UArizona
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Keywords provided by Hong Lei, University of Arizona:
Electroacupuncture
Body Worn Sensor
Gait
Balance
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases