Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201829248437 Date of Approval: 21/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Gaze direction recognition task on balance in Cervicogenic headache patients: Randomized Controlled Trial
Official scientific title Effect of Gaze direction recognition task on balance in Cervicogenic headache patients: Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Individuals with cervicogenic headache have impaired standing balance but possibly to different extent and patterns(Sremakaew M, et al., 2013).Balance control is important not only to maintain postural stability, but also to assure safe mobility related activities.( Horak FB. 2003). Impaired balance is known as one of the main risk factors for falls.( Ambrose AF, et al., 2013) As a result of the changing mechanical properties of cervical structures, including ligaments, muscles, and bones, flexion–relaxation phenomenon and erector spinae muscle activation are responsible for proprioception sense alteration(Mousavi-Khatir R, et al.,2016).While sensorimotor control decreases, repositioning errors increase in cervical joints due to damage of cervical proprioceptive inputs and sensorimotor integration.All these changes, which result in the loss of proprioceptive skills that are an important part of balance, lead to sensorimotor defects, muscle inhibition,muscle atrophy, and muscle fatigue. Therefore,the treatment for sensorimotor problems should be included balance training, such as cervical region proprioceptive exercises, in addition to conventional treatment. It has been reported that proprioceptive training improves proprioceptive acuity and is effective in the reduction of errors in joint position.( Yousif N, et al., 2015) Recently many researchers studied effect of proprioceptive training on balance in patients with chronic neck pain (CNP)( Duray M, et al., 2018) and aim of this study is to study effect of proprioceptive training on balance in patients with Cervicogenic headache. Measurements Measurement will be taken before and after the predetermined sessions. 1- Measurement of Balance HUMAC balance system was used to assess balance as it is a reliable and valid way of balance assessment that proved its efficacy when it was compared to the results of the conventional force platform.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 04/10/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 29/11/2021
Actual Last follow-up date 08/12/2022
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
012003409 P.T.REC
012004976 P.T.REC
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group traditional program 2 months all participants will continue an outpatient rehabilitation program for 60 minutes, 3 times/week for 2 successive months. The selected physical therapy (SPT) program comprised 20 mins of hot pack, 20 mins of Transcutaneous Electrical Nerve Stimulation, and 5 mins of ultrasound application to the neck and therapeutic exercises (ROM, postural training and isometric exercises (chin tuck)). 20 Active-Treatment of Control Group
Experimental Group proprioception 2 months , all participants will continue an outpatient rehabilitation program for 60 minutes, 3 times/week for 2 successive months. The selected physical therapy (SPT) program comprised 20 mins of hot pack, 20 mins of Transcutaneous Electrical Nerve Stimulation, and 5 mins of ultrasound application to the neck and therapeutic exercises (ROM, postural training and isometric exercises (chin tuck)). (Duray M,et al.,2018) Therapeutic exercises will be performed three times in a day as 10 sets. This rehabilitation protocol will be the same for all patients in both groups. The participants of the study group underwent the GDRE program in addition to the CPT program for 10 min in each session. GDRE is a new practice used to improve the proprioception sense of cervical muscles and to rehabilitate patients with neck disability. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All participants with cervicogenic headache will be diagnosed by an experienced neurologist according to the current diagnostic criteria for cervicogenic headache (Headache Classification Committee of the International Headache, 2013) 1. Their age will be ranged from : 35-49 Al Khalili Y, et al. (2020). They will be randomly assigned in to two groups. Group A (control group) will receive selected physical therapy rehabilitation. Group B will receive proprioceptive training with selected physical therapy rehabilitation. 2. Unilateral pain starting in the neck and radiating to the frontotemporal region, 3. Pain aggravated by neck movement, 4. Restricted cervical range of motion(CROM) 5. Joint tenderness in at least one of the joints of the upper cervical spine (C1-C3), and 6. Headache frequency of at least 1 per month continous over the past year. Patients will be excluded if they have any of the following exclusive criteria (Hall T., et al.,2007): 1- Previous history of injury and surgery of head and neck. 2- Musculoskeletal problems/disorders (e.g. cervical radiculopathy,Lumbar radiculopathy,Hip problems,knee problems,ankle problems, myopathy, advanced osteoporosis, head/neck trauma) 3- Neurological problems/diseases (e.g. Parkinson’s disease, epilepsy, brain tumors, stroke). 4- Metabolic syndromes (e.g. diabetes, hypo-/hyperthyroidism). 5- Hyper or hypotension 6- Vestibular disorders , inner ear inflammation Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 49 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/10/2021 cairo university
Ethics Committee Address
Street address City Postal code Country
1 Gamaa Street, Giza, Egypt giza 12613 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/11/2023 Cairo University
Ethics Committee Address
Street address City Postal code Country
1 Gamaa Street, Giza, Egypt Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome balance 4 months
Secondary Outcome Range of motion.pain.neck disability index 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kafrelsheikh university hospital University Hospital, El Gish St, Qism Kafr El-Shaikh, Kafr El-Shaikh kafr elsheikh 33511 Egypt
KFS General Hospital General Hospital, Kafr El-Sheikh Department, First Division, Kafr El-Sheikh City, Kafr El-Sheikh kafr elsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed abd elaziz emam kafr elsheikh start center beside emad eldin new markets kafr elsheikh 33511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor kafr elsheikh university Mubarak Road, Kafr Abu Tabl, First Division, Kafr El-Sheikh City, Kafr El-Sheikh kafr elsheikh 33511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Magda Ramadan Zahran giza eldoki giza 12651 Egypt
Salma Mohamed Ragab awal el montaza Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator magda ramadan magdaramadan2000@yahoo.com 01025891348 doki
City Postal code Country Position/Affiliation
giza 12651 Egypt lecturer of physiotherapy basic science department
Role Name Email Phone Street address
Public Enquiries fatma sedik naseemelshawk@gmail.com 01223417697 ben elsarayat
City Postal code Country Position/Affiliation
giza Egypt professor of physiotherapy basic science department
Role Name Email Phone Street address
Scientific Enquiries salma ragab salmaragab200@gmail.com 01111188596 awal el montaza
City Postal code Country Position/Affiliation
alexandria Egypt lecturer of neuromedicine faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information