NCT03846037

Brief Summary

Introduction: Proprioception refers to the information's dynamic, sent to central nervous system by the free nerve endings and mechanoreceptors, about the biomechanics relationship for the joint tissue. The proprioceptive exercises show a big prophylactic action by musculoskeletal injuries. Among the top modalities of these exercises, it can be cited the Whole Body Vibration (WBV). Objectives: The objective of this study was to evaluate and compare the joint position sense, muscle electric activity and the postural sway in healthy individuals, before and after performing proprioceptive exercises on the vibrational platform or on a stable surface. Materials and Methods: 20 healthy young (24,85 + 4,27 years) were recruited, randomly divided into two groups, Control Group (GC) and Experimental Group (GE). Were realized evaluates of the proprioception by means of the joint position sense, the muscle electric activity of peroneus longus, gastrocnemius medialis, vastus medialis and gluteus medium, and the postural sway by means of the postural sway before and after one assistance consisting of 4 sets of 60s with unipodal standing position on soil (GC) or on vibrational platform (GE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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 5, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2015

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

2.4 years

First QC Date

February 11, 2019

Last Update Submit

February 15, 2019

Conditions

Keywords

ProprioceptionBalanceWhole-body VibationOne-foot Stance

Outcome Measures

Primary Outcomes (3)

  • Evaluation of the sense of joint position.

    The sense of joint position was achieved by means of the isokinetic dynamometer (Biodex System 3) triggered in Proprioception mode. Then, the knee joint of each volunteer was slowly extended by the examiner, next to the equipment, at a speed of 20 ° per second, starting from an angle of 90 ° flexion, to the predetermined extension angles: 60 ° and 30 °. With vision occlusion, each volunteer was instructed to memorize the angle, within ten seconds, and then return to the same angle for three attempts.

    Before of the application of the protocol exercises

  • Evaluation of the muscular electrical activity (Surface electromyograph) of the muscles long fibular, medial gastrocnemius, vastus medialis and gluteus medius .

    For the acquisition of electromyographic data, the 8-channel electromyograph was used. The muscles evaluated were the long fibular, the medial gastrocnemius, the vastus medialis and the gluteus medius. Sinak was added for 20 seconds.

    Before of the application of the protocol exercises

  • Evaluation of the Postural oscillation

    The signal for the ground reaction force was acquired by a force platform, which gave the values related to the Vertical Reaction Force of the volunteers. For this, the vertical force platform EMG System do Brasil, model BIOMEC400 was used. During the evaluation, the subjects reproduced the unipodal support position over the non-dominant lower limb with the contralateral limb in a knee flexion near 90 ° within 20 seconds. The equipment was installed on a solid and flat base to avoid undesirable vibrations and displacement during the application of forces on the upper surface.

    Before of the application of the protocol exercises

Secondary Outcomes (3)

  • Evaluation of the sense of joint position

    After one exercise session (after 1º day of treatment)

  • Evaluation of the muscular electrical activity of the muscles of the long fibular, the medial gastrocnemius, the vastus medialis and the gluteus medius

    After one exercise session (after 1º day of treatment)

  • Evaluation of the Postural oscillation

    After one exercise session (after 1º day of treatment)

Study Arms (2)

Ground

PLACEBO COMPARATOR

Participants in this group perform protocol exercises on a stable surface.

Other: Proprioceptive exercise on the ground (stable surface)

vibrating platform

EXPERIMENTAL

Participants in this group perform protocol exercises on a vibrating platform.

Other: Proprioceptive exercise on the vibratory platform

Interventions

Unipodal support over the non-dominant lower limb with the contralateral limb in a knee flexion near 90ºon the vibratory platform

vibrating platform

Unipodal support over the non-dominant lower limb with the contralateral limb in a knee flexion near 90ºon the ground

Ground

Eligibility Criteria

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

You may qualify if:

  • Individuals from 18 to 30 years;
  • Healthy;
  • Sedentary;
  • That they agree with the Free and Informed Consent Term.

You may not qualify if:

  • Recent surgery;
  • Open wounds;
  • Contagious skin diseases;
  • Glaucoma;
  • Labyrinthitis;
  • Uncontrolled heart diseases;
  • Pacemaker;
  • Lower limb injuries;
  • Neurological dysfunctions;
  • Pain in the lower limbs;
  • Use of drugs that alter the balance;
  • Alcohol consumption in the previous 24 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratório de Engenharia de Reabilitação Sensorio Motora

São José dos Campos, São Paulo, 55, Brazil

Location

Study Officials

  • Fernanda PS Lima, Researcher

    Universidade do Vale do Paraíba

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 19, 2019

Study Start

March 5, 2013

Primary Completion

August 10, 2015

Study Completion

October 3, 2015

Last Updated

February 19, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations