Trials / Completed
CompletedNCT02556164
Electro-acupuncture for Gait and Balance in Parkinson's Disease
Objective Assessment of Electro-acupuncture Efficacy for Gait and Balance in Patients With Parkinson's Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2016-06-30
- Completion
- 2017-06-30
- First posted
- 2015-09-22
- Last updated
- 2017-11-09
Source: ClinicalTrials.gov record NCT02556164. Inclusion in this directory is not an endorsement.