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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03156530
Other study ID # 50015413300005440
Secondary ID
Status Completed
Phase N/A
First received May 5, 2017
Last updated May 15, 2017
Start date March 1, 2015
Est. completion date November 1, 2016

Study information

Verified date March 2016
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

By using a static stabilometry platform, the investigators believe the possible verification of the efficiency of auricular acupuncture points that correlates with regions of our body that may interfere with static equilibrium.

The present work aims to analyze the effect of the stimulation of atrial points of the lower limbs on the equilibrium response evaluated by static stabilometry.


Description:

Balance is an extremely relevant subject because of the large and increasing incidence of falls mainly in the elderly population. This leads to a significant social impact since falls can lead an elderly to increasing dependence on the family and can be the cause of depression and reduce their quality of life. Studies have already demonstrated the efficacy of acupuncture stimulation in the treatment of vertigo and also for the improvement of postural control. For this, the option of auricular acupuncture was chosen because it is a non-invasive and safe method. Thus, the objective of this study will be to analyze the effects of atrial stimulation of the lower limbs on the equilibrium response by static stabilometry. Participants in this study were 40 healthy individuals aged between 18 and 30 years who will be divided into two groups: GA (acupuncture group) (n = 20) and CG (control group) (n = 20). The acupuncture group will be stimulated unilaterally according to the motor preference side of each individual in the points referring to the three joints of the lower limb (knee and ankle hip). The control group will not receive stimulation. Balance evaluations will be performed before the stimuation (initial), 20 minutes after the initiation of the protocol (second evaluation) and 5 minutes after the second evaluation, with eyes open and closed. Participants will be positioned standing with their arms along their body, mouth closed not with force and parallel feet. Statistical analysis will be performed by means of a one-way analysis of variance (ANOVA) and the differences between the data will be evidenced by Holm Sidack's post-test. Values of p≤0.05 will be considered significant.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 1, 2016
Est. primary completion date March 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- 40 healthy individuals between the ages of 18 and 30

Exclusion Criteria:

- Disorders of the central nervous system

- Joint pathologies

- Peripheral neuropathies

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Auricular acupunture
Evaluation of balance before, during and after applying of auricular acupuncture.
Other:
Control
Not receive stimulation.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of center of force through stabilometry Evaluation shall be performed during the treatment period. 1 day
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