- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846037
Evaluation of the Balance, Muscular Electric Activity, Proprioception Before and After in the Vibratory Platform
Effects of Proprioceptive Exercises Associated With Vibratory Stimuli on Electromyographic Activity, Postural Oscillation and Sense of Joint Position in Healthy Individuals
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
São José dos Campos, São Paulo, Brazil, 55
- Laboratório de Engenharia de Reabilitação Sensorio Motora
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Ground
Participants in this group perform protocol exercises on a stable surface.
|
Unipodal support over the non-dominant lower limb with the contralateral limb in a knee flexion near 90ºon the ground
|
|
Experimental: vibrating platform
Participants in this group perform protocol exercises on a vibrating platform.
|
Unipodal support over the non-dominant lower limb with the contralateral limb in a knee flexion near 90ºon the vibratory platform
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 .
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.
|
Before of the application of the protocol exercises
|
|
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. |
Before of the application of the protocol exercises
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the sense of joint position
Time Frame: After one exercise session (after 1º day of treatment)
|
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)
|
|
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)
|
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)
|
|
Evaluation of the Postural oscillation
Time Frame: After one exercise session (after 1º day of treatment)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fernanda PS Lima, Researcher, Universidade do Vale do Paraíba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CAAE 18643413.3.0000.5503
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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