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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03846037
Other study ID # CAAE 18643413.3.0000.5503
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 5, 2013
Est. completion date October 3, 2015

Study information

Verified date February 2019
Source Universidade do Vale do Paraíba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

The individuals who composed the two groups performed the same exercise protocol, however, on different surfaces:

- Control group: stable surface.

- Experimental group - vibratory platform, make / model Nissan Fisio; orbital amplitude: 6 mm; frequency: 30 Hz The exercises consisted of unipodal support on the non-dominant lower limb with the contralateral limb in a knee flexion near 90º. This exercise is a proprioceptive test that requires more than all joints and musculature of the lower limb, and is widely used in studies, for providing obvious clinical signs in the presence of dysfunctions.

Activities were performed with the individual standing without using any type of footwear, remaining without support of the hands and with the upper limbs abducted to 90º with the fixed eye on the horizon line. Both groups performed 4 sets of 60s of sustained posture. In the intervals between the series there was the rest of 60s, remaining in orthostasis with support of the upper limbs.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 3, 2015
Est. primary completion date August 10, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Individuals from 18 to 30 years;

- Healthy;

- Sedentary;

- That they agree with the Free and Informed Consent Term.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Proprioceptive exercise on the vibratory platform
Unipodal support over the non-dominant lower limb with the contralateral limb in a knee flexion near 90ºon the vibratory platform
Proprioceptive exercise on the ground (stable surface)
Unipodal support over the non-dominant lower limb with the contralateral limb in a knee flexion near 90ºon the ground

Locations

Country Name City State
Brazil Laboratório de Engenharia de Reabilitação Sensorio Motora São José dos Campos São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Universidade do Vale do Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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. After one exercise session (after 1º day of treatment)
Secondary Evaluation of the muscular electrical activity of the muscles of the long fibular, the medial gastrocnemius, the vastus medialis and the 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. After one exercise session (after 1º day of treatment)
Secondary 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.
After one exercise session (after 1º day of treatment)
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