Muscle FatigueNCT03998280
The Effect Of Cervical Muscle Fatigue in Neck Proprioception and Postural Stability
An observational study of Muscle Fatigue, run by Alaa Yousri Mahmoud Atia at 1 site in Egypt.
Trial summary
PURPOSE: To investigate the effect of cervical muscle Fatigue on neck proprioception and postural stability during cervical flexion. BACKGROUND: Postural stability is the ability to maintain the body in equilibrium either at rest or in a steady state of motion . Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Muscle Fatigue
- What is being tested?
- Assessment
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Mar 2019to 20 Jul 2020
- Phase
- Observational
- 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 40 years
- All sexes
- Adult
Study population: Residents from certain town
Who may be able to join
- having cervical range of motion 80 to 90 of flextion, 70 degree of extension, 20 to 45 degrees if lateral flextion, and 80 to 90 rotation to both sides.
- having normaluscle test strength for cervical neck flexors according to group manual muscle test
- body mass index ranging from 18.5 to 24.9 kg/m2
Who cannot join
- any history of pathological truma to the cervical,thoracic or lumbar spine, upper extremity or rib cage.
- surgical condition of the spine
- having any orthopedic, musculoskeletal or neurological disorders around cervical region.
- any vestibular impairment (e.g.vertigo)
- spinal postural deformities as hyper kyphosis \&scoliosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ministry of Health
Cairo, Giza Governorate, 00202
Alaa Y Atia, Bachelor's, 00201061445332, dr.lolo2018@gmail.com
About this study
Official title: The Effect of Cervical Muscle Fatigue on Neck Proprioception and Postural Stability
PURPOSE:
To investigate the effect of cervical muscle Fatigue on neck proprioception and postural stability during cervical flexion.
Read more
BACKGROUND:
Postural stability is the ability to maintain the body in equilibrium either at rest or in a steady state of motion . Muscle fatigue is the diminished response of muscle to repeated stimulus. Cervical proprioceptive inputs provide important somatosensory information influencing postural stability. Hence, the investigators performed this study to evaluate the effect of experimentally induced fatigue on general cervical musculature on postural stability .
HYPOTHESES:
This study will hypnotize that:
- Cervical flexor muscle fatigue will have a significant effect on neck proprioception
- Cervical muscle fatigue will have a significant effect on posture stability
RESEARCH QUESTION:
Will fatigue of cervical flexors have an effect on neck proprioception and postural stability?
Read the detailed description
the research methodology that will be used
Induction of fatigue using isometric neck flexor muscle endurance test (NET):
An isometric neck muscle endurance test (NME test) will be performed for the deep neck flexors (Rectus Capitus Anterior, Rectus Capitus Lateralis, Longus Capitus, Longus Colli) until exhaustion in all participants occurs. With the subject in hook lying position through CHIN RETRACTION AND HEAD ELEVATED FROM THE COUCH.
All the assessment measurements will be done before and just immediately after performing the cervical muscle fatigue then after 15 minutes of fatigue induction(fatigue recovery) A. Measurement of neck proprioception using cervical joint position error test via OVERHEAD LASER POINTER
- Measurement of postural stability using :
- Biodex balance system(limit of stability) to measure postural stability
- Multi-Directional Reach Test
- Conditions
- Muscle Fatigue
- Being tested
- Assessment
- Keywords
- fatigue ,deep neck flexor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentDevice
Neck proprioception and postural stability
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction of fatigue using isometric neck flexor muscle endurance test (NET):
- An isometric neck muscle endurance test (NME test) will be performed for the deep neck flexors (Rectus Capitus Anterior, Rectus Capitus Lateralis, Longus Capitus, Longus Colli) until exhaustion in all participants occurs. with the subject in hook lying position through CHIN RETRACTION AND HEAD ELEVATED FROM THE COUCH.
Measured: six months
Secondary outcomes (1)
Measurement of neck proprioception using cervical joint position error test via OVERHEAD LASER POINTER
: A laser pointer will be fixed to a headband or strap. Target paper will be typically 40 cm in diameter that contains concentric circles in 1 cm increments, divided into 4 quadrants intersecting at the zero.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start31 Mar 2019
- Primary completion15 Jun 2020
- Study completion20 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FatigueStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa Yousri Mahmoud Atia
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Alaa Yousri Mahmoud Atia, Ministry of Health and Population, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998280
- Sponsor's protocol ID
- P. T. REC/012/002299
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2019
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cervical Muscle Fatigue on Neck Proprioception and Postural Stability
- ClinicalTrials.gov ID
- NCT03998280
- Acronym / sponsor ID
- P. T. REC/012/002299
- Conditions
- Muscle Fatigue
- Keywords
- fatigue ,deep neck flexor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Alaa Yousri Mahmoud AtiaOther government
- Study start
- 31 Mar 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 20 Jul 2020 (estimated)
- First posted
- 26 Jun 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.
PURPOSE:
To investigate the effect of cervical muscle Fatigue on neck proprioception and postural stability during cervical flexion.
BACKGROUND:
Postural stability is the ability to maintain the body in equilibrium either at rest or in a steady state of motion . Muscle fatigue is the diminished response of muscle to repeated stimulus. Cervical proprioceptive inputs provide important somatosensory information influencing postural stability. Hence, the investigators performed this study to evaluate the effect of experimentally induced fatigue on general cervical musculature on postural stability .
HYPOTHESES:
This study will hypnotize that:
- Cervical flexor muscle fatigue will have a significant effect on neck proprioception
- Cervical muscle fatigue will have a significant effect on posture stability
RESEARCH QUESTION:
Will fatigue of cervical flexors have an effect on neck proprioception and postural stability?
Detailed description
the research methodology that will be used
Induction of fatigue using isometric neck flexor muscle endurance test (NET):
An isometric neck muscle endurance test (NME test) will be performed for the deep neck flexors (Rectus Capitus Anterior, Rectus Capitus Lateralis, Longus Capitus, Longus Colli) until exhaustion in all participants occurs. With the subject in hook lying position through CHIN RETRACTION AND HEAD ELEVATED FROM THE COUCH.
All the assessment measurements will be done before and just immediately after performing the cervical muscle fatigue then after 15 minutes of fatigue induction(fatigue recovery) A. Measurement of neck proprioception using cervical joint position error test via OVERHEAD LASER POINTER
- Measurement of postural stability using :
- Biodex balance system(limit of stability) to measure postural stability
- Multi-Directional Reach Test
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Residents from certain town
Key inclusion criteria (3 listed)
- having cervical range of motion 80 to 90 of flextion, 70 degree of extension, 20 to 45 degrees if lateral flextion, and 80 to 90 rotation to both sides.
- having normaluscle test strength for cervical neck flexors according to group manual muscle test
- body mass index ranging from 18.5 to 24.9 kg/m2
Key exclusion criteria (5 listed)
- any history of pathological truma to the cervical,thoracic or lumbar spine, upper extremity or rib cage.
- surgical condition of the spine
- having any orthopedic, musculoskeletal or neurological disorders around cervical region.
- any vestibular impairment (e.g.vertigo)
- spinal postural deformities as hyper kyphosis \&scoliosis
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 |
|---|---|---|
| AssessmentNeck proprioception and postural stability | Device | – |
Primary outcome
Induction of fatigue using isometric neck flexor muscle endurance test (NET):
Time frame: six months
a. An isometric neck muscle endurance test (NME test) will be performed for the deep neck flexors (Rectus Capitus Anterior, Rectus Capitus Lateralis, Longus Capitus, Longus Colli) until exhaustion in all participants occurs. with the subject in hook lying position through CHIN RETRACTION AND HEAD ELEVATED FROM THE COUCH.
1 secondary outcome
Measurement of neck proprioception using cervical joint position error test via OVERHEAD LASER POINTER
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Fatigue, run by Alaa Yousri Mahmoud Atia at 1 site in Egypt.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jun 2020. 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 Egypt. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Y Atia, Bachelor's (021061445332, dr.lolo2018@gmail.con), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction of fatigue using isometric neck flexor muscle endurance test (NET): (time frame: six months). 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 18 Jun 2020.