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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of forward head posture on sensorimotor integration
Scientific title
Effect of forward head posture on amplitude and latency of somatosensory evoked potential compared to healthy participants'
Secondary ID [1] 287751 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subjects with forward head posture 296621 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296862 296862 0 0
Musculoskeletal 297268 297268 0 0
Other muscular and skeletal disorders

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
there will be no intervention
1-Assessment of forward head posture:
The base of the camera was set at the height of the subjects’ shoulder. The tragus of the ear was marked, and a plastic pointer was taped to the skin overlying the spinous process of the C7 vertebra. We measured the craniovertebral angle, which is defined as the angle between a horizontal line passing through C7 and a line extending from the tragus of the ear to C7. (Mi-Young Lee, 2014).
The subject is seated and we take a lateral view picture. (Sjan-Mari van Niekerk, 2008).
2-somatosensory evoked potential (SSEPs):

Position of the patient:
Because the very small size of the cortical potentials, frontal, spinal,and erbs point very good relaxation of the subject is vital Therefore ,the subject was lay supine on a softly padded table with pillows under the head and knees. Skin preparation under the stimulating electrode:
Skin overlying the dermatome, was carefully washed using methylated alcohol, and then dried by rubbing the skin with dry clean cotton wool. This procedure was repeated until the skin become red aiming to reduce skin resistance .Great care was taken not to break or abrade the skin under the stimulating electrode, as they may the stimulus painful.

Skin preparation under the recording electrode:
Careful attention was paid to cleaning and scarifying the skin before the attachment of the recording electrodes in the scalp. The hair was separated and the skin in between was thoroughly cleaned by methylated alcohol and sand paper was used to gently abrade the skin sites by removing several superficial layers of the skin and skin oils. It is generally accepted that abrasion is considered sufficient when the impedance measured across two such electrode preparation sites is between 1,000 and 5,000O. When the impedance is less than 1000 ohm, care must be taken to avoid a situation in which amplifier is short –circuited through aberrant conduction pathway such as excess perspiration or electrolyte paste between two electrodes. As in this instance, the impedance through the abnormal conducting pathway is less than through the electrodes and the biological signal would rather the path of least impedance, thereby by passing the instrument (Dumitru, 1995).
Stimulation procedure
Stimuli consisted of electrical square pulses, 1ms in duration delivered at rates of 2.47Hz and 4.98Hz through Ag/AgCl ECG conductive adhesive electrodes (’MEDITRACE’ 130 by Ludlow Technical Products Canada Ltd., Mansfield, MA) (impedance <5 kO) placed over the median nerve and ulnar nerve separately and both nerve at the same time at the wrist of the right hand, with anode proximal. SEPs were recorded at the two rates since the slow rate 2.47Hz does not lead to SEP peak attenuation and the fast rate 4.98Hz attenuates the N30 SEP peak resulting in the N24 SEP peak being accurately measurable . The stimulus intensity was increased until motor threshold was achieved for each individual participant. Motor threshold was defined as the lowest stimulation intensity that evoked a visible muscle contraction of the abductor pollicisbrevis muscle theses procedures will be done for median nerve and ulnar nerve and both of them.
SEP recording parameters
SEP recording electrodes (1.8288m Traditional Lead, 10mm disc, 2mm hole gold cup EEG electrodes, Grass Technologies, An Astro-Med, Inc. Subsidiary, Rockland, MA) (impedance <5 kO) were placed according to the International Federation of Clinical Neurophysiologists (IFCN) recommendations. Recording electrodes were placed on the ipsilateral Erb’s point, over C5 spinous process (Cv5), the anterior neck (tracheal cartilage), 2cm posterior to contralateral central C3/4, which will be referred to as Cc’, and a frontal cite (6cm anterior and 2cm contralateral to Cz), which will be referred to as the Rossi site .. The C5 spinous process was referenced to the trachea while all other electrodes were referenced to the ipsilateral earlobe. A 1.8288m Traditional Lead, 10mm disc, 2mm hole gold cup EEG electrode was also used as a ground, placed in the mouth of participants.
All stimulating and recording procedure will be performed before and after the motor typing task for 20 minutes for both Group A and Group B .
Typing task involves typing out a paragraph of a text as quickly and accurately as possible for 20 minutes.
'We will compare between the amplitude and latency of somatosensory evoked potential on subjects with forward head and normal subject before and after performing typing task'
Intervention code [1] 293146 0
Early Detection / Screening
Comparator / control treatment
there will be no treatment
we will compare between amplitude of somatosensory evoked potential in subjects with forward head posture and healthy subject
Control group

Primary outcome [1] 296463 0
Sensorimotor integration assessed by amplitude of somatosensory evoked potential
Timepoint [1] 296463 0
before and immediately after performing motor typing task(typing)
Primary outcome [2] 298836 0
latency of somatosensory evoked potential assessed by somatosensory evoked potential test also
Timepoint [2] 298836 0
before and immediately after motor typing task
Secondary outcome [1] 318506 0
Assessment of forward head
severity of forward head posture
forward head assessment by Photographic analysis:
Photographs were taken using the Photographic Posture
Analysis Method (PPAM)(Sjan-Mari van Niekerk,2008). This method consisted of:
1. A camera (8 mega pixel).
2. A plastic pointer markers
3. Computerfor downloading images,Windows8.
4. Surgimap software (Weifei Wu,2014)
Timepoint [1] 318506 0
before measuring of somatosensory evoked potential

Key inclusion criteria
1-60 subjects of both sexes age ranging from 18 to 25years old.
2-All participants will be assessed by the investigator using photographic analysis and then classify into two group.
Group A all subject participate in this group will be diagnosed as forward head subjects.
Group B all subject participate in this group will be healthy subject.
Minimum age
18 Years
Maximum age
25 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1-Any abnormal brain function such as epilepsy,multiplesclerosis,abnormal peripheral nerve function
2-Any history of cervical spine disk herniation
3-Current acute pain

Study design
Convenience sample
Statistical methods / analysis
1-Descriptive analysis:
It includes:
The mean (X): as an average describing the central tendency of observation.
The standard deviation (SD): as a measure of the dispersion of the result around the mean
2-Inferential statistics:-
T-test will be used to identify the difference within and between both groups.
Person correlation between two group
The level of significance will be set < of 0.05
I performed a pilot study and did power analysis and the result was 60 subjects
A power calculation indicated that 30 subjects will be needed in each group to detect mean difference between groups of 1.19 on the peak to peak amplitude assuming a standard deviation 1.4 (two tailed hypothesis, alpha =o.o5.power =90%)

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 7281 0
State/province [1] 7281 0

Funding & Sponsors
Funding source category [1] 292291 0
Self funded/Unfunded
Name [1] 292291 0
shimaa taha abu el kasem
Address [1] 292291 0
3084 entrance A flat 51 zahraa naser city cairo egypt
Country [1] 292291 0
Primary sponsor type
shimaa taha abu el kasem
3084 entrance A flat 51 zahraa naser city cairo egypt
Secondary sponsor category [1] 290978 0
Name [1] 290978 0
Address [1] 290978 0
Country [1] 290978 0

Ethics approval
Ethics application status
Ethics committee name [1] 293768 0
Ethical committee of faculty of physical therapy
Ethics committee address [1] 293768 0
7 Ahmed El Zayat street postcode 12624 Giza Egypt faculty of physical therapy Cairo university
Ethics committee country [1] 293768 0
Date submitted for ethics approval [1] 293768 0
Approval date [1] 293768 0
Ethics approval number [1] 293768 0

Brief summary
the study will be inducted to investigate the effect of bad posture in form of forward head posture on sensorimotor integration. the sensorimotor integration will be assessed by measuring somatosensory evoked potential .the study will be performed by comparing between the forward head group and normal subject group.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 61050 0
Mrs shimaa taha
Address 61050 0
7 Ahmed El Zyaat ST postcode 12624 Giza Egypt faculty of physical therapy Cairo university
Country 61050 0
Phone 61050 0
Fax 61050 0
Email 61050 0
Contact person for public queries
Name 61051 0
Prof omaima kattabei
Address 61051 0
7 Ahmed El Zyaat ST postcode 12624 Giza Egypt faculty of physical therapy Cairo university
Country 61051 0
Phone 61051 0
Fax 61051 0
Email 61051 0
Contact person for scientific queries
Name 61052 0
A/Prof ibrahim hustafa
Address 61052 0
7 Ahmed El Zyaat ST postcode 12624 Giza Egypt faculty of physical therapy Cairo university
Country 61052 0
Phone 61052 0
Fax 61052 0
Email 61052 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary