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IRCT20160131026279N3 IRCT 2020-05-05 Tehran University of Medical Sciences Effect of rehabilitation on treatment of mild cognitive impairment Investigating the effect of galvanic vestibular stimulation and vestibular rehabilitation on spatial memory of patients with amnestic mild cognitive impairment 2020-09-22 anticipated 48 Complete https://irct.ir/trial/47249 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Individual random assignment to four equal groups with block randomization method using blocks of size 4; Randomization and random sequential allocation: done with Random Allocation Software; Allocation concealment: done with sequentially numbered, sealed, opaque envelopes. N/A amnestic mild cognitive impairment. Intervention 1: Intervention group 1: receiving GVS and VR, GVS: Subliminal noisy GVS, 20 min, once a week, three sessions. VR: Cooksey-Cawthorne rehabilitation exercises, 30 min, twice a day for one month. Intervention 2: Intervention group 2: receiving VR only. VR: Cooksey-Cawthorne rehabilitation exercises, 30 min, twice a day for one month. Intervention 3: Intervention group 3: receiving GVS only. GVS: Subliminal noisy GVS, 20 min, once a week, three sessions. Intervention 4: Control group: no intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is -
public Mansoureh Adel Ghahraman
Enghelab Ave.
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 4364 madel@tums.ac.ir Tehran University of Medical Sciences scientific Mansoureh Adel Ghahraman
Enghelab Ave.
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 4364 madel@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosed with aMCI MMSE test score <21 for participants with primary school education and <23 for participants with a university degree MoCA test score between 19 and 24 Adequate visuomotor coordination based on the standard score (Z Score ± 1) in motor screening task (MOT) test Normal or modified visual acuity or with glasses (20/20) using the Snellen chart in order to correctly diagnose CANTAB test forms Normal hearing ability or corrected hearing loss with hearing aid to hear the stimulus in the force plate test 18 years no limit Both Color blindness according to Ishihara test for color blindness Neck pain or limitation in neck range of motion Anticholinergic drug consumption (e.g. hyoscine and atropine) consumption Consumption of drugs affecting vestibulo-ocular reflex such as Cinnarizine , betahistine, painkillers, and tranquilizers from 48 hours prior to tests History of orthopedic problems in the last 6 months (lower extremity fractures, dislocation, and pain) Obvious lower extremity deformities such as scoliosis and kyphosis according to observation of a physiotherapist History of rheumatic and/or metabolic diseases History of alcoholism or addiction G31.84 Mild cognitive impairment, so stated Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group 1: receiving GVS and VR, GVS: Subliminal noisy GVS, 20 min, once a week, three sessions. VR: Cooksey-Cawthorne rehabilitation exercises, 30 min, twice a day for one month Intervention group 2: receiving VR only. VR: Cooksey-Cawthorne rehabilitation exercises, 30 min, twice a day for one month Intervention group 3: receiving GVS only. GVS: Subliminal noisy GVS, 20 min, once a week, three sessions. Control group: no intervention Montreal Cognitive Assessment score. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: Montreal Cognitive Assessment (MoCA). Learning score. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: Rey Auditory Verbal Learning Test. Immediate recall score. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: Rey Auditory Verbal Learning Test. Delayed recall score. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: Rey Auditory Verbal Learning Test. Percentage of correct answers in pattern recognition memory (PRM). Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: CANTAB test. Response latency in Delayed Matching to Sample. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: CANTAB test. Percentage of correct selection in Delayed Matching to Sample. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: CANTAB test. Percentage of errors in Paired Associates Learning. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: CANTAB test. Spatial Span length. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: CANTAB test. Vestibulo-ocular reflex gain. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: video head impulse test (vHIT). Percentage of overt saccades. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: video head impulse test (vHIT). Percentage of covert saccades. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: video head impulse test (vHIT). Vestibulo-ocular reflex gain asymmetry. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: video head impulse test (vHIT). Displacement of center of pressure in both anterior-posterior and medial-lateral directions in anticipation, weight transfer, and locomotion. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: force-plate test. Velocity of displacement of center of pressure in both anterior-posterior and medial-lateral directions in anticipation, weight transfer, and locomotion. Timepoint: Before, immediately after the end of the intervention period, and one month later. Method of measurement: force-plate test. Tehran University of Medical Sciences Approved 2020-02-19 Ethics committee of School of Nursing and Midwifery & Rehabilitation ,Tehran University of Medical S Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)