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

University of Arizona

Status: Completed

Conditions: Parkinson's Disease

Treatments: Procedure: Electroacupuncture; Other: Body-worn sensor technology

Study type: Interventional

Funder types: Other

Identifiers

NCT02556164

UArizona

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Real EA

Experimental group

Description:

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.

Treatment:

Procedure: Electroacupuncture

Other: Body-worn sensor technology

Sham EA

Sham Comparator group

Description:

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.

Treatment:

Procedure: Electroacupuncture

Other: Body-worn sensor technology