HealthyLPSNCT06852729
Effect of Induced Trunk Extensors Fatigue on Balance and Lumbar Position Sense in Adolescents
A study testing Biering-sorenson protocol in people with Healthy and Adolescent, run by Cairo University.
Trial summary
this study will be conducted to investigate the effect of trunk extensors induced fatigue on balance and lumber position sense in adolescents Read more about this study
- Who is it for?
- Ages 16 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Adolescent
- What is being tested?
- Biering-sorenson protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Visual or hearing defects.
- Congenital abnormalities.
- Musculoskeletal abnormalities.
- Recent trauma.
- Cardiac and respiratory problems.
- Smoker participant.
- Low back pain.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
this study will be conducted to investigate the effect of trunk extensors induced fatigue on balance and lumber position sense in adolescents
Read the 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
- Conditions
- Healthy, Adolescent
- Being tested
- Biering-sorenson protocol
- Keywords
- induced trunk extensor fatigue, balance, Lumbar Position Sense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biering-sorenson protocolOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Biering-sorenson protocol | Experimental | Biering-Sorensen protocol will be used to induce back muscle fatigue, and a marked decrease in the maximum force in trunk extension Receives: Other: Biering-sorenson protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
Assessment of balance will be done using the biodex balance system
Measured: up to thirty minutes
joint position error
Inclinometer will be used to assess lumbar joint position error
Measured: up to thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start10 Mar 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Biering-sorenson protocol will be applied to induce back muscle fatigue
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED GAMAL ABD EL-NASSER ALI, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852729
- Sponsor's protocol ID
- P.T.REC/012/005624
- Acronym
- LPS
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Induced Trunk Extensors Fatigue on Balance and Lumbar Position Sense in Adolescents
- ClinicalTrials.gov ID
- NCT06852729
- Acronym / sponsor ID
- LPS / P.T.REC/012/005624
- Conditions
- Healthy, Adolescent
- Keywords
- induced trunk extensor fatigue, balance, Lumbar Position Sense
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 28 Feb 2025 (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.
this study will be conducted to investigate the effect of trunk extensors induced fatigue on balance and lumber position sense in adolescents
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Biering-sorenson protocol will be applied to induce back muscle fatigue
| Arm | Type | Receives |
|---|---|---|
| Biering-sorenson protocol | Experimental | Other: Biering-sorenson protocolBiering-Sorensen protocol will be used to induce back muscle fatigue, and a marked decrease in the maximum force in trunk extension |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- Visual or hearing defects.
- Congenital abnormalities.
- Musculoskeletal abnormalities.
- Recent trauma.
- Cardiac and respiratory problems.
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 |
|---|---|---|
| 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. | Other | Biering-sorenson protocol |
Primary outcome
balance
Time frame: up to thirty minutes
Assessment of balance will be done using the biodex balance system
joint position error
Time frame: up to thirty minutes
Inclinometer will be used to assess lumbar joint position error
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Biering-sorenson protocol in people with Healthy and Adolescent, run by Cairo University.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed G Ali, master (01122068350, Ahmedgamalali1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance (time frame: up to thirty minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.