Forward Head PostureNCT05103111
Effect of FHP on TMJ Proprioception in Postmenopausal Women
An observational study of Forward Head Posture, run by Cairo University.
Trial summary
anterior protrusion of head in relation to the trunk; It has a high prevalence among old women as increased age is associated with a reduced cervical range of motion (ROM), greater thoracic kyphosis which is associated with greater cervical flexion and greater forward head posture accompanying with greater deficits in… Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Forward Head Posture
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2021to 28 Mar 2022
- 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The postmenopausal women will be divided into two groups according to their cranio-vertebral angle (CVA). The FHP group will consist of 50 women, suffering from FHP (CVA is less than 48°). The control group will consist of 50 women, not having FHP (CVA is more than 48°).
Who may be able to join
- postmenopausal women
- their age will range from 50 to 60 years
- their body mass index (BMI) will range from 25 to 28 kg/m2
Who cannot join
- any identified or acquired dental defects
- existing dental prosthesis use, visual, voice and hearing disabilities
- facial paralysis
- orofacial, neck or shoulder fractures or procedures
- fixed or mobile spinal deformity
- headache
- migraine
- any vestibular or neurological condition that may impair TMJ proprioception.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Forward Head Posture on Temporomandibular Joint Proprioception in Postmenopausal Women. an Observational Study
anterior protrusion of head in relation to the trunk; It has a high prevalence among old women as increased age is associated with a reduced cervical range of motion (ROM), greater thoracic kyphosis which is associated with greater cervical flexion and greater forward head posture accompanying with greater deficits in cervical ROM of flexion and rotation. So, the aim of the study is to determine the effect of forward head posture on temporomandibular joint proprioception in postmenopausal women
Read the detailed description
A convenient sample of 100 postmenopausal women will be participated in this study; they are divided into 2 groups according to their cranio-vertebral angle (CVA). The FHP group will be consisted of 50 women, suffer from FHP (CVA was less than 48°). The control group will be consisted of 50 women, are free from FHP (CVA more than 48°).
The participants will be recruited from Faculty of Physical Therapy, Cairo University and Faculty of Physical Therapy, MUST University. Informed consent will be obtained from each participant after explaining the nature, purpose, and benefits of the study, informing them of their right to refuse or withdraw at any time, and about the confidentiality of any obtained information.
- Conditions
- Forward Head Posture
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| FHP group (study group) | it will be consisted of 50 women, suffering from FHP (CVA is less than 48°) Receives: Other: No intervention | |
| control group (without FHP) | it will be consisted of 50 women, not having FHP (CVA is more than 48°). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of cranio-vertebral angle (CVA)
The CVA is angle formed by a horizontal line drawn through the spinous process of seventh cervical vertebra c7 and line connecting spinous process of c7 and tragus of the ear. the markers will be placed on c7 and tragus of the ear and a photo will be captured by using digital camera from lateral view for three times .Then, the photographs of the woman are then transferred to the device to be analyzed by the Surgimap spine programme which by measuring the angle between a horizontal line passing through C7 and a line extending from the tragus of the ear to C7, calculated the positions of the anatomical points on the photographs to calculate the CVA ,the average of 3 times measurement will be taken, the cut-off point for CVA was 48 °; the woman with less than 48 ° CVA is considered having FHP, whereas the woman with more than 48 ° CVA is considered healthy .
Measured: up to 3 months
Measurement of mouth opening angle
The woman will be instructed to open her mouth as much as possible. The calliper then calculated the vertical distance between the incisal edge of the maxillary central incisor and the labioincisal edge of the opposing mandibular incisor.
Measured: up to 3 months
Measurement of mandibular protrusion
The initial position was the physiological resting position (average space of 3 mm between the occlusal surfaces of the maxillary and mandibular teeth) of the mandible . The woman was told from that role to shift her mandible anteriorly without contact with the tooth. The calliper then measured the gap from the incisal edge of the maxillary central incisor to the incisal edge of the mandibular central incisor.
Measured: up to 3 months
Measurement of lateral movements of the mandible
The initial position was the physiological resting position from which the woman was advised to shift her mandible to the right and then to the left as far as possible. Then the calliper assessed the distance between the labioincisal embrasures of the maxillary central incisor to the labioincisal embrasure of the opposing mandibular incisor.Then, to measure the functional ROM of TMJ, the full ROM of TMJ in each direction was divided by three. In each direction, the caliper was adjusted at the functional ROM to train the woman to move her jaw from the starting position to that functional ROM for 3 times. Then for 3 times with open eyes and 3 times with closed eyes, the woman was asked to shift her jaw actively from the star-ting position to the functional ROM of each direction and the therapist assessed the ROM by the digital caliper in each time.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start15 Nov 2021 (estimated)
- Primary completion15 Feb 2022 (estimated)
- Study completion28 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forward Head PostureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, manal ahmed el-shafei mohamed, Cairo University
- Investigators
- Manal Ahmed, lecturer, Principal investigator, lecturer of physical therapy for women's health, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103111
- Sponsor's protocol ID
- P.T.REC/012/003297
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Forward Head Posture on Temporomandibular Joint Proprioception in Postmenopausal Women. an Observational Study
- ClinicalTrials.gov ID
- NCT05103111
- Acronym / sponsor ID
- P.T.REC/012/003297
- Conditions
- Forward Head Posture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (estimated)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 28 Mar 2022 (estimated)
- First posted
- 2 Nov 2021 (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.
anterior protrusion of head in relation to the trunk; It has a high prevalence among old women as increased age is associated with a reduced cervical range of motion (ROM), greater thoracic kyphosis which is associated with greater cervical flexion and greater forward head posture accompanying with greater deficits in cervical ROM of flexion and rotation. So, the aim of the study is to determine the effect of forward head posture on temporomandibular joint proprioception in postmenopausal women
Detailed description
A convenient sample of 100 postmenopausal women will be participated in this study; they are divided into 2 groups according to their cranio-vertebral angle (CVA). The FHP group will be consisted of 50 women, suffer from FHP (CVA was less than 48°). The control group will be consisted of 50 women, are free from FHP (CVA more than 48°).
The participants will be recruited from Faculty of Physical Therapy, Cairo University and Faculty of Physical Therapy, MUST University. Informed consent will be obtained from each participant after explaining the nature, purpose, and benefits of the study, informing them of their right to refuse or withdraw at any time, and about the confidentiality of any obtained information.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FHP group (study group) | – | Other: No interventionit will be consisted of 50 women, suffering from FHP (CVA is less than 48°) |
| control group (without FHP) | – | Other: No interventionit will be consisted of 50 women, not having FHP (CVA is more than 48°). |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The postmenopausal women will be divided into two groups according to their cranio-vertebral angle (CVA). The FHP group will consist of 50 women, suffering from FHP (CVA is less than 48°). The control group will consist of 50 women, not having FHP (CVA is more than 48°).
Key inclusion criteria (3 listed)
- postmenopausal women
- their age will range from 50 to 60 years
- their body mass index (BMI) will range from 25 to 28 kg/m2
Key exclusion criteria (8 listed)
- any identified or acquired dental defects
- existing dental prosthesis use, visual, voice and hearing disabilities
- facial paralysis
- orofacial, neck or shoulder fractures or procedures
- fixed or mobile spinal deformity
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 |
|---|---|---|
| No interventionno intervention | Other | FHP group (study group), control group (without FHP) |
Primary outcome
Measurement of cranio-vertebral angle (CVA)
Time frame: up to 3 months
The CVA is angle formed by a horizontal line drawn through the spinous process of seventh cervical vertebra c7 and line connecting spinous process of c7 and tragus of the ear. the markers will be placed on c7 and tragus of the ear and a photo will be captured by using digital camera from lateral view for three times .Then, the photographs of the woman are then transferred to the device to be analyzed by the Surgimap spine programme which by measuring the angle between a horizontal line passing through C7 and a line extending from the tragus of the ear to C7, calculated the positions of the anatomical points on the photographs to calculate the CVA ,the average of 3 times measurement will be taken, the cut-off point for CVA was 48 °; the woman with less than 48 ° CVA is considered having FHP, whereas the woman with more than 48 ° CVA is considered healthy .
Measurement of mouth opening angle
Time frame: up to 3 months
The woman will be instructed to open her mouth as much as possible. The calliper then calculated the vertical distance between the incisal edge of the maxillary central incisor and the labioincisal edge of the opposing mandibular incisor.
Measurement of mandibular protrusion
Time frame: up to 3 months
The initial position was the physiological resting position (average space of 3 mm between the occlusal surfaces of the maxillary and mandibular teeth) of the mandible . The woman was told from that role to shift her mandible anteriorly without contact with the tooth. The calliper then measured the gap from the incisal edge of the maxillary central incisor to the incisal edge of the mandibular central incisor.
Measurement of lateral movements of the mandible
Time frame: up to 3 months
The initial position was the physiological resting position from which the woman was advised to shift her mandible to the right and then to the left as far as possible. Then the calliper assessed the distance between the labioincisal embrasures of the maxillary central incisor to the labioincisal embrasure of the opposing mandibular incisor.Then, to measure the functional ROM of TMJ, the full ROM of TMJ in each direction was divided by three. In each direction, the caliper was adjusted at the functional ROM to train the woman to move her jaw from the starting position to that functional ROM for 3 times. Then for 3 times with open eyes and 3 times with closed eyes, the woman was asked to shift her jaw actively from the star-ting position to the functional ROM of each direction and the therapist assessed the ROM by the digital caliper in each time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Individual participant dataSharing planned: Yes
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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.
Manal Ahmed, lecturer principal investigator
lecturer of physical therapy for women's health, Cairo university
Questions about this trial
What is this clinical trial studying?
An observational study of Forward Head Posture, 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 3 inclusion and 8 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 2 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal Ahmed, Lecturer (01220664518, manalpt1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of cranio-vertebral angle (CVA) (time frame: up to 3 months). The study lists 4 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 2 Nov 2021.