A Pilot Clinical Trial to Objectively Assess the Efficacy of Electroacupuncture on Gait in Patients with Parkinson's Disease Using Body Worn Sensors

Abstract

Background: Gait disorder, a key contributor to fall and poor quality of life, represents a major therapeutic challenge in Parkinson's disease (PD). The efficacy of acupuncture for PD remains unclear, largely due to methodological flaws and lack of studies using objective outcome measures.

Objective: To objectively assess the efficacy of electroacupuncture (EA) for gait disorders using body-worn sensor technology in patients with PD.

Methods: In this randomized pilot study, both the patients and assessors were masked. Fifteen PD patients were randomly assigned to an experimental group (n = 10) or to a control group (n = 5). Outcomes were assessed at baseline and after completion of three weekly EA treatments. Measurements included gait analysis during single-task habitual walking (STHW), dual-task habitual walking (DTHW), single-task fast walking (STFW), dual-task fast walking (DTFW). In addition, Unified Parkinson's Disease Rating Scale (UPDRS), SF-12 health survey, short Falls Efficacy Scale-International (FES-I), and visual analog scale (VAS) for pain were utilized.

Results: All gait parameters were improved in the experimental group in response to EA treatment. After adjustment by age and BMI, the improvement achieved statistical significant level for gait speed under STHW, STFW, and DTFW (9%-19%, p<0.05) as well as stride length during DTFW (9%, p = 0.037) and midswing speed during STFW (6%, p = 0.033). No significant changes were observed in the control group (p>0.110). The highest correlation between gait parameters and UPRDS scores at baseline was observed between gait speed during STFW and UPDRS II (r = -0.888, p = 0.004). The change in this gait parameter in response to active intervention was positively correlated with baseline UPDRS (r = 0.595, p = 0.057). Finally, comparison of responses to treatment between groups showed significant improvement, prominently in gait speed (effect size 0.32-1.16, p = 0.001).

Conclusions: This study provides the objective proof of concept for potential benefits of non-pharmaceutical based EA therapy on enhancing gait in patients with PD.

Trial registration: ClinicalTrials.gov NCT02556164.

Fig 1. CONSORT Flow Diagram.

Fig 2. Changes in gait speed pre- and post-treatment in the intervention group (blue color) and control group (orange color) during single-task habitual, dual-task habitual, single-task fast and dual-task fast walking conditions.

Mean values and standard errors are illustrated. Only the values for those parameters, which achieved statistical significant level were illustrated.

Fig 3

(A) Association between baseline gait speed during Single Task Fast Walking (STFW) condition and baseline UPDRS Part II. The negative correlation suggests that those with poor UPDRS score walk slower in the intervention (real EA) group; (B) Association between changes in magnitude of gait speed during STFW in response to EA treatment and baseline UPDRS Part II. The positive correlation suggests that those with poor baseline UPDRS score may benefit more from EA treatment. (C) Association between changes in magnitude of gait speed during STFW and changes in magnitude of UPDRS. Negative correlation suggests that enhancement in gait speed in response to EA treatment is associated with enhancement in UPDRS score.