NCT03156530

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
Last Updated

May 17, 2017

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

May 5, 2017

Last Update Submit

May 15, 2017

Conditions

Keywords

AcupuntureAcupunture TherapyAcupunture PointsAcupunture EarPostural Balance

Outcome Measures

Primary Outcomes (1)

  • Evaluation of center of force through stabilometry

    Evaluation shall be performed during the treatment period.

    1 day

Study Arms (2)

Auricular acupuncture

EXPERIMENTAL

Stimulated with needles at three joint points of the lower limb, knee and ankle. Balance assessments will be performed prior to (initial) pacing, 20 minutes after the initiation of the pacing protocol (second evaluation) and after 5 minutes the final evaluation.

Device: Auricular acupunture

Control

PLACEBO COMPARATOR

Not receive stimulation.

Other: Control

Interventions

Evaluation of balance before, during and after applying of auricular acupuncture.

Auricular acupuncture
ControlOTHER

Not receive stimulation.

Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individuals between the ages of 18 and 30

You may not qualify if:

  • Disorders of the central nervous system
  • Joint pathologies
  • Peripheral neuropathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The subjects were randomized between the groups and the auricular stimulation was performed unilaterally, the motor preference side being standardized as the stimulated side
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This study is a randomized controlled clinical trial to analyze the influence of auricular points on lower limbs on the equilibrium response assessed by static stabilometry
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
João Eduardo de Araujo

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 17, 2017

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

November 1, 2016

Last Updated

May 17, 2017

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share