Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000182493
Ethics application status
Approved
Date submitted
30/10/2015
Date registered
11/02/2016
Date last updated
20/06/2017
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)
U1111-1175-9773
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
Physiotherapy
Musculoskeletal 297268 297268 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
there will be no intervention
Procedures:
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 et.al, 2014).
The subject is seated and we take a lateral view picture. (Sjan-Mari van Niekerk et.al, 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
Active

Outcomes
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 et.al,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 et.al,2014) http://www.surgimapspine.com).
Timepoint [1] 318506 0
before measuring of somatosensory evoked potential

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2016
Actual
20/03/2016
Date of last participant enrolment
Anticipated
1/07/2016
Actual
18/06/2016
Date of last data collection
Anticipated
Actual
1/07/2016
Sample size
Target
60
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 7281 0
Egypt
State/province [1] 7281 0
cairo

Funding & Sponsors
Funding source category [1] 292291 0
Self funded/Unfunded
Name [1] 292291 0
shimaa taha abu el kasem
Country [1] 292291 0
Egypt
Primary sponsor type
Individual
Name
shimaa taha abu el kasem
Address
3084 entrance A flat 51 zahraa naser city cairo egypt
Country
Egypt
Secondary sponsor category [1] 290978 0
None
Name [1] 290978 0
Address [1] 290978 0
Country [1] 290978 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293768 0
Ethical committee of faculty of physical therapy
Ethics committee address [1] 293768 0
Ethics committee country [1] 293768 0
Egypt
Date submitted for ethics approval [1] 293768 0
15/05/2015
Approval date [1] 293768 0
30/05/2015
Ethics approval number [1] 293768 0
P.T.REC/012/00865

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Egypt
Phone 61050 0
+201229823327
Fax 61050 0
Email 61050 0
[email protected]
Contact person for public queries
Name 61051 0
omaima kattabei
Address 61051 0
7 Ahmed El Zyaat ST postcode 12624 Giza Egypt faculty of physical therapy Cairo university
Country 61051 0
Egypt
Phone 61051 0
+201222194545
Fax 61051 0
Email 61051 0
[email protected]
Contact person for scientific queries
Name 61052 0
ibrahim hustafa
Address 61052 0
7 Ahmed El Zyaat ST postcode 12624 Giza Egypt faculty of physical therapy Cairo university
Country 61052 0
Egypt
Phone 61052 0
+201227022334
Fax 61052 0
Email 61052 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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