Effect of Muscular Energy Technique on Postural Control

May 8, 2023 updated by: Universidade Norte do Paraná

Immediate Effect of the Muscle Energy Technique on Postural Control in the Elderly and Young Adults

The research aims to evaluate the immediate effect of the muscle energy technique (TEM) on postural control responses in the elderly and young adults. The sample will be selected for convenience, being participants of both sexes, young and old. Evaluation of postural control through the force platform will be performed during the unipodal and semi-tandem balance tests. The main parameters of postural control will be calculated using the pressure center derivative. After the balance tests, the participants will be submitted to TEM and immediately afterwards reassessed on the force platform.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aging is considered a dynamic and progressive process, in which morphological, functional and biochemical changes occur. One of the factors associated with old age is the decrease in the ability to balance posture and the high risk of falls. The literature brings the benefits of physical exercise in improving balance and preventing falls. However, few studies point to the benefits of flexibility techniques and their relationship with balance. The objective of this research is to evaluate the immediate effect of the muscle energy technique (TEM) on postural control responses in the elderly and young adults. The sample will be selected for convenience, with 50 participants of both sexes, young people between 18 and 35 years old and elderly people between 60 and 85 years old. Evaluation of postural control will be performed through the force platform during the unipodal and semi-tandem balance tests (2 repetitions of 30 seconds each, with rest of 30 seconds between them). The main parameters of postural control will be calculated using the pressure center derivative. After the balance tests, the participants will be submitted to TEM and immediately afterwards reassessed on the force platform. An analysis of variance will be used to compare the effects between groups (young versus elderly) and intervention (pre- and post-TEM) and the effects of interaction on the main variables of postural control. A beneficial effect of TEM is expected, especially in the elderly group. The results found in this study will contribute to the use of TEM and the increase of relevant clinical information to benefit the ability to balance in the elderly, in order to reduce the risk of falls.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Rubens da Silva, PHD
  • Phone Number: 55 43 3371-9848
  • Email: rubens@unopar.br

Study Contact Backup

Study Locations

  • Brazil
    • Parana
      • Londrina, Parana, Brazil, 86041-120
        • Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Accepting to participate in a study on a voluntary basis;
  • Aged between 18 and 35 years old for young adults and over 60 years old up to 85 years old for elderly people;
  • Being physically independent;
  • Not practicing regular physical activity as recommended by the ACSM 3 to 5 times a week with moderate and severe;
  • Cognitive status> 18 in the Mini-Mental State Examination.

Exclusion Criteria:

  • Elderly with cognitive changes detectable by the Mini Mental State Examination (MMSE);
  • A score lower than the score predicted for their level of education;
  • Self-reported injuries;
  • Falls in the last year;
  • Musculoskeletal disorders;
  • Systemic neurological-degenerative disease;
  • Severe labyrinthitis and chronic diseases of the cardiovascular or respiratory system.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Muscle energy technique (G1)
Group Elderly (G1)
Other: Muscular Energy Technique G1
Group of older (G1) - The muscular energy technique (TEM) based on Chaitow's proposal will be applied to the postural posterior muscles of the lower limbs such as gastrocnemius, soleus, ischiostibials, gluteus medius and paravertebral. During TEM, the contraction will be maintained from 7 to 10 seconds, against the resistance imposed by the therapist. After relaxation, range of motion will be gained until your new restriction barrier. This process will be repeated for 3 times.
Other Names:
  • "MET"
Active Comparator: Muscle energy technique (G2)
Group of young people (G2)
Other: Muscular Energy Technique G2
Group of young people (G2) - The muscular energy technique (TEM) based on Chaitow's proposal will be applied to the postural posterior muscles of the lower limbs such as gastrocnemius, soleus, ischiostibials, gluteus medius and paravertebral. During TEM, the contraction will be maintained from 7 to 10 seconds, against the resistance imposed by the therapist. After relaxation, range of motion will be gained until your new restriction barrier. This process will be repeated for 3 times.
Other Names:
  • ''MET''

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: Baseline
Balance measured by a Force platform
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Norte do Paraná

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PP07009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Balance Disorders Water

Clinical Trials on Muscular Energy Technique G1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings