TherapeuticsNCT03846037

Evaluation of the Balance, Muscular Electric Activity, Proprioception Before and After in the Vibratory Platform

A study testing Proprioceptive exercise on the vibratory platform and Proprioceptive exercise on the ground (stable surface) in people with Therapeutics, run by Universidade do Vale do Paraíba at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Therapeutics
What is being tested?: Proprioceptive exercise on the vibratory platform and Proprioceptive exercise on the ground (stable surface)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteBrazil
Study dates: 5 Mar 2013to 3 Oct 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Recent surgery;
Open wounds;
Contagious skin diseases;
Glaucoma;
Labyrinthitis;
Uncontrolled heart diseases;

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Laboratório de Engenharia de Reabilitação Sensorio Motora
São José dos Campos, São Paulo, 55

Other trials in Brazil

About this study

Official title: Effects of Proprioceptive Exercises Associated With Vibratory Stimuli on Electromyographic Activity, Postural Oscillation and Sense of Joint Position in Healthy Individuals

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).

Read the detailed 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.

Conditions: Therapeutics
Being tested: Proprioceptive exercise on the vibratory platform, Proprioceptive exercise on the ground (stable surface)
Keywords: Proprioception, Balance, Whole-body Vibation, One-foot Stance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03846037
Study group	Role	What they receive
Ground	Placebo comparator	Participants in this group perform protocol exercises on a stable surface. Receives: Other: Proprioceptive exercise on the ground (stable surface)
vibrating platform	Experimental	Participants in this group perform protocol exercises on a vibrating platform. Receives: Other: Proprioceptive exercise on the vibratory platform

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Before of the application of the protocol exercises

Secondary 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.
Measured: 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
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.
Measured: After one exercise session (after 1º day of treatment)
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.
Measured: After one exercise session (after 1º day of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 20133 Oct 2015

First posted19 Feb 2019
Study start5 Mar 2013
Primary completion10 Aug 2015
Study completion3 Oct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for TherapeuticsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03846037
Sponsor's protocol ID: CAAE 18643413.3.0000.5503
Status last verified: Feb 2019
First submitted: 11 Feb 2019
Last updated: 19 Feb 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Proprioceptive Exercises Associated With Vibratory Stimuli on Electromyographic Activity, Postural Oscillation and Sense of Joint Position in Healthy Individuals
ClinicalTrials.gov ID: NCT03846037
Acronym / sponsor ID: CAAE 18643413.3.0000.5503
Conditions: Therapeutics
Keywords: Proprioception, Balance, Whole-body Vibation, One-foot Stance
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Universidade do Vale do ParaíbaUniversity, hospital or other
Study start: 5 Mar 2013 (actual)
Primary completion: 10 Aug 2015 (actual)
Study completion: 3 Oct 2015 (actual)
First posted: 19 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Ground	Placebo comparator	Other: Proprioceptive exercise on the ground (stable surface)Participants in this group perform protocol exercises on a stable surface.
vibrating platform	Experimental	Other: Proprioceptive exercise on the vibratory platformParticipants in this group perform protocol exercises on a vibrating platform.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

Recent surgery;
Open wounds;
Contagious skin diseases;
Glaucoma;
Labyrinthitis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Proprioceptive exercise on the vibratory platformUnipodal support over the non-dominant lower limb with the contralateral limb in a knee flexion near 90ºon the vibratory platform	Other	vibrating 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	Other	Ground

Primary outcome

Evaluation of the sense of joint position.
Time frame: Before of the application of the protocol exercises
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.
Evaluation of the muscular electrical activity (Surface electromyograph) of the muscles long fibular, medial gastrocnemius, vastus medialis and gluteus medius .
Time frame: Before of the application of the protocol exercises
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.
Evaluation of the Postural oscillation
Time frame: Before of the application of the protocol exercises
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.

3 secondary outcomes

Evaluation of the sense of joint position
Time frame: 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
Time frame: After one exercise session (after 1º day of treatment)
Evaluation of the Postural oscillation
Time frame: After one exercise session (after 1º day of treatment)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fernanda PS Lima, Researcher study director

Universidade do Vale do Paraíba

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the sense of joint position. (time frame: Before of the application of the protocol exercises). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03846037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.