NCT05103111

Brief 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 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

September 28, 2021

Last Update Submit

October 28, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 .

    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.

    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.

    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.

    up to 3 months

Study Arms (2)

FHP group (study group)

it will be consisted of 50 women, suffering from FHP (CVA is less than 48°)

Other: No intervention

control group (without FHP)

it will be consisted of 50 women, not having FHP (CVA is more than 48°).

Other: No intervention

Interventions

no intervention

FHP group (study group)control group (without FHP)

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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°).

You may qualify if:

  • postmenopausal women
  • their age will range from 50 to 60 years
  • their body mass index (BMI) will range from 25 to 28 kg/m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Manal Ahmed, lecturer

    lecturer of physical therapy for women's health, Cairo university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manal Ahmed, Lecturer

CONTACT

rovan saad, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for women's health

Study Record Dates

First Submitted

September 28, 2021

First Posted

November 2, 2021

Study Start

November 15, 2021

Primary Completion

February 15, 2022

Study Completion

March 28, 2022

Last Updated

November 2, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF