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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Procedure: Electroacupuncture; Other: Body-worn sensor technology

• Registration Number: NCT02556164
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Primary Completion: 2016-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham EA	Body-worn sensor technology	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.
Real EA	Electroacupuncture	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.
Real EA	Body-worn sensor technology	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.
Sham EA	Electroacupuncture	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.

Primary Outcome Measures

Name	Time	Method
Change of gait speed by objective measurement	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

Name	Time	Method
Change of postural balance (COG) by objective measurement	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.
Change of stride length by objective measurement	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.
Change of postural balance (Ankle/hip sway) by objective measurement	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.
Change of Unified Parkinson's Disease Rating Scale	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)
Change of SF-12 health survey	3 weeks	SF-12 health survey (MCS, PCS)
Change of Short Falls Efficacy Scale-International	3 weeks	(Short FES-I, 7-28)
Change of the visual analog scale	3 weeks	the visual analog scale (VAS, 0-10) for pain,
Potential adverse events related to acupuncture	Baseline, 1 week, 2 week and 3 weeks.	measured by Adverse Events Report Related to Acupuncture