Effect of Induced Trunk Extensors Fatigue on Balance and Lumbar Position Sense in Adolescents (LPS)

February 25, 2025 updated by: AHMED GAMAL ABD EL-NASSER ALI, Cairo University
this study will be conducted to investigate the effect of trunk extensors induced fatigue on balance and lumber position sense in adolescents

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Fatigue can be defined as, decrease in the power generation capacity of the muscles from the beginning of the movement due to internal homeostasis breakdown caused by an increase in energy production demanded by an external stimulus that lead to general decrease in physical performance related to a rise within the real/perceived difficulty of a task or exercise, as well as the inability of the muscles to keep up with the specified level of strength during exercises. Either Adolescents spending long time using smartphone, they are more likely to have their spine in an incorrect posture causing damage to the surrounding skeletal structures as well as to ligaments which affect the proprioception input of the spine. Muscle fatigue is an important condition that impairs sensorimotor integration, proprioception, and thus postural control. Muscle fibers and Golgi tendon organ activity decrease with fatigue, resulting in changes in joint proprioception and afferent output from joint and muscle receptors. Fatigue of postural muscles such as lumbar extensor and abdominal muscles impairs postural control and may form the basis for injuries. Fatigue can also impair the proprioceptive and kinesthetic properties of the joints. this study aims to investigate how the trunk extensor muscles respond to a fatigue inducing exercise, especially concerning balance and trunk lumbar position sense for understanding and preventing musculoskeletal injury and lowering risk in health adolescents in primary care and to contribute to preventive rehabilitation. Sixty-eight normal adolescent boys will participate in this study

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

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

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.

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Only boys will be included.
  • Their age will range from 16 to 18 years old.
  • Never trained any specific sport before.
  • They have a normal body mass index (BMI) between 16.4 to 24.8 kg/m2 according to
  • No history of low back (pain intensity 0-1 cm) according to 10 cm visual analog scale (VAS)
  • Physical fitness of all participants will be (minimally active) according to International Physical Activity Questionnaire- Short Form (IPAQ-SF)

Exclusion Criteria:

  • Visual or hearing defects.
  • Congenital abnormalities.
  • Musculoskeletal abnormalities.
  • Recent trauma.
  • Cardiac and respiratory problems.
  • Smoker participant.
  • Low back pain.

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: N/A
  • Interventional Model: Single Group 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: Biering-sorenson protocol
Biering-Sorensen protocol will be used to induce back muscle fatigue, and a marked decrease in the maximum force in trunk extension
Other: Biering-sorenson protocol
  • Students shouldn't perform any vigorous activity a day before assessment.
  • Frist, therapist will request from each participant to watch videos to understand how the test should be applied.
  • The starting position will be a half prone lying on a plinth with the superior edge of the iliac crest horizontal at the edge of the plinth and the arms crossed over the chest.
  • The participant should keep the unsupported upper part of the body.
  • The lower limbs will strategically be stabilized with straps.
  • The participant will be asked to maintain the upper body in a horizontal position and the timer started.
  • The test ends if the participant can maintain the previous position for 4 minutes (240 seconds) or can no longer maintain the set position before 4 minutes elapses. The stop time is recorded.
  • There is considerable range of mean fatigue times reported for the Biering-Sørensen test in the literature ranging from 84s to 180s in healthy males.

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: up to thirty minutes
Assessment of balance will be done using the biodex balance system
up to thirty minutes
joint position error
Time Frame: up to thirty minutes
Inclinometer will be used to assess lumbar joint position error
up to thirty minutes

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.
Cairo University

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 (Estimated)

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.
March 10, 2025

Primary Completion (Estimated)

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.
May 30, 2025

Study Completion (Estimated)

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.
May 30, 2025

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).
February 25, 2025

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.
February 25, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
February 25, 2025

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.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • P.T.REC/012/005624

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.

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