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IRCT20181209041897N1 IRCT 2019-04-10 Shiraz University of Medical Sciences Comparison of the effect of computer game and conventional proprioceptive training in neck region on pain, disability and balance in patients with cervical radicular pain Comparison of the effect of virtual reality and conventional proprioceptive training in neck region on pain, functional variables and balance in patients with cervical radiculopathy 2019-05-22 anticipated 45 Complete https://irct.ir/trial/35776 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: People through Block Randomization and sealed opaque envelopes concealment fall into three groups, Blinding description: In this study, the outcome assessor as well as data analyzer will be blinded to the group allocation. N/A Cervical Radiculopathy. Intervention 1: Control group: This group do the isometric neck exercise, deep neck flexor strengthening exercise, shoulder and scapular strengthening exercise for 10 sessions, three times a week in home. It will check by the physiotherapist once weekly. Intervention 2: First intervention group: This group do home exercises plus a computar game designed to improve cervicocephalic kinesthesia, eye-head coordination, reflexes related to head and neck, eye and vestibular system with their head and neck movements.The stages of the game are designed easy to difficult sequentially. Ten exercise sessions each lasted 20 minutes is programed. 5 minutes warm up exercises will be performed at the beginning of each session. Intervention 3: Second intervention group: This group do home exercises plus conventional neck proprioceptive exercises including: The combination of joint position sense and movement sense training (by using laser beam fixed on the head), gaze stability training, eye and head coordination training will be performed in each session and they will be progressed in the next sessions. The duration of each training session and the number of training sessions are the same as first intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is because each person s data without overall evaluation is practically useless
public Mohsen Razeghi
School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran
Shiraz Iran (Islamic Republic of) 1733-71345 +98 71 3627 1551 ext. 213 RazeghM@Sums.ac.ir Shiraz University of Medical Sciences scientific Mohsen Razeghi
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
shiraz Iran (Islamic Republic of) 1733-71345 +98 71 3627 1551 ext. 213 RazeghM@Sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 40-60 years old pain history more than 3 month The average of the highest and lowest pain in the past day was at least 30 to a maximum of 60 out of 100 mm according to Visual Analoge Scale in neck or upper limb with numbness or tingling or weakness in one or two hands refered by specialist with cervical radiculoathy diagnosis 3 out of 4 tests become positive: spurling test, distraction test, upper limb tension test 1. cervical rotation less than 60 degree have moderate disability according to neck disability index between 15 to 25 out of 50 score have at least 4.5 degree head reposistioning error in 4 directions( Flextion, Extension, Rotation to right and left) 40 years 60 years Both Positive Vertebral Artery test Steroidal injection in recent two past weeks history of neck or thorasic surgery myelopathy Upper motor neuron lesion sign & symptom for example: stroke ,Multiple sclerosis and amyotrophic lateral sclerosis medical red flags like: tumor, fracture, Rheumatoid arthritis and Long-term use of steroid medications People with thorasic outlet syndrome, tennis elbow and carpal tunnel syndrome Taking effective balance medication over the past 72 hours Vestibular problems People who Regularly used analgesic and anti-inflammatory drugs due to neck problem. M50.1 Cervical disc disorder with radiculopathy Rehabilitation Rehabilitation Rehabilitation Control group: This group do the isometric neck exercise, deep neck flexor strengthening exercise, shoulder and scapular strengthening exercise for 10 sessions, three times a week in home. It will check by the physiotherapist once weekly. First intervention group: This group do home exercises plus a computar game designed to improve cervicocephalic kinesthesia, eye-head coordination, reflexes related to head and neck, eye and vestibular system with their head and neck movements.The stages of the game are designed easy to difficult sequentially. Ten exercise sessions each lasted 20 minutes is programed. 5 minutes warm up exercises will be performed at the beginning of each session. Second intervention group: This group do home exercises plus conventional neck proprioceptive exercises including: The combination of joint position sense and movement sense training (by using laser beam fixed on the head), gaze stability training, eye and head coordination training will be performed in each session and they will be progressed in the next sessions. The duration of each training session and the number of training sessions are the same as first intervention group. Pain. Timepoint: Before intervention, 48 hr after intervention & a month later. Method of measurement: Visual Analoge Scale. Disability. Timepoint: Before intervention, 48 hr after intervention & a month later. Method of measurement: Neck Disability Index questionnaire. Head Reposition Error. Timepoint: Before intervention, 48 hr after intervention & a month later. Method of measurement: Laser pointer & Graded page. Balance. Timepoint: Before intervention, 48 hours after intervention & a month later. Method of measurement: Modified Star Excursion Balance test. Kinsiophobia. Timepoint: Before intervention, 48 hours after intervention & a month later. Method of measurement: Tampa Scale of Kinsiophobia questionnaire. Neuromuscular control of head and neck movements. Timepoint: Before intervention, 48 hours after intervention & a month later. Method of measurement: Time of movement duty. Shiraz University of Medical Sciences Approved 2018-12-08 Research Ethics Committee of Shiraz School of Rehabilitation Sciences School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran shiraz Fars Iran (Islamic Republic of)