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IRCT20160221026674N7 IRCT 2025-11-05 Shiraz University of Medical Sciences Investigating the effect of physiotherapy on sensory and balance problems in patients with multiple sclerosis Investigating the effect of sensory retraining technique on paresthesia and balance in patients with multiple sclerosis: a randomized clinical trial 2025-11-06 anticipated 30 Complete https://irct.ir/trial/85490 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of 15, intervention (sensory retraining exercises and drug therapy) and control (drug therapy), using a permutation randomization method with number of blocks of 5 and a block size of 6. Randomization will be performed manually by an epidemiologist. Random assignment of samples to groups is done with the ratio of 1:1 and with the help of numbered envelopes. Before performing the initial evaluation of each of the samples, the corresponding envelope is returned by the therapist at the Faculty of Rehabilitation Sciences in Shiraz, Blinding description: The assessor and the therapist are two different people, so the assessor is unaware of which of the two groups each participant is placed in. 3 Multiples Sclerosis. Intervention 1: Intervention group: Sensory retraining exercises (4 weeks, 3 days a week, 60 minutes each time) with daily use of gabapentin (300 mg/day) or pregabalin (100 mg/day) for 4 weeks. The intervention consists of 4 sensory activities: stimulation of the sense of touch, recognition of the texture of objects, understanding the position of the limbs, and practice of two-point discrimination (ACTOVERCO Pharmaceutical Company). Intervention 2: Control group: Daily use of gabapentin (300 mg/day) or pregabalin (100 mg/day) for 4 weeks (ACTOVERCO Pharmaceutical Company). Yes - There is a plan to make this available What will be shared: Information collection form including primary and secondary outcomes, informed consent form and SPSS file When: After publication the results of the study To whom: Researchers working in academic and scientific institutions Conditions: Only for recording information in scientific databases Where to obtain: Correspondence with the project manager by email. mohamadm@sums.ac.ir How to obtain: Maximum one month after sending the request by email Comments:
public Marzieh mohamadi
School of Rehabilitation Sciences, Shahid Doran Campus, after Amir-al-momenin Burn Accident Hospital, Sadra Town Road
Shiraz Iran (Islamic Republic of) 7198754361 +98 71 3212 2600 mohamadm@sums.ac.ir Shiraz University of Medical Sciences scientific Marzieh mohamadi
School of Rehabilitation Sciences, Shahid Doran Campus, after Amir-al-Momenin Burn Accident Hospital, Sadra Town Road
Shiraz Iran (Islamic Republic of) 7198754361 +98 71 3212 2600 mohamadm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Diagnosis of MS and confirmation of the diagnosis by a neurologist according to McDonald criteria and the patient's medical reports Extended Disability Status Scale (EDSS) score less than 6 Willing and able to comply with the study requirements Self-reported paresthesia symptoms including tingling, prickling, prickling, burning, crawling (like an insect moving across the skin), itching, partial numbness, and any abnormal sensation; score of at least 4 out of 10 on at least one of the symptoms of neuropathy (numbness, tingling, prickling, and any abnormal sensation) on a visual analogue scale in the legs in the past four weeks Balance Disorder Report: The Mini-Balance Evaluation Systems Test (Mini-BESTest) will be used. Absence of MS relapses for at least the past 30 days (defined as episodes of focal neurological impairment lasting more than 24 hours and without an alternative explanation). 18 years no limit Both Central or peripheral nervous system disorders such as head trauma, stroke, diabetes Presence of any wounds or swelling at the treatment site (legs) Systemic diseases Pregnancy lupus Use of Tricyclic antidepressants and Serotonin-norepinephrine reuptake inhibitors family drugs by patients during the study period G35 Multiple sclerosis Treatment - Other Treatment - Drugs Intervention group: Sensory retraining exercises (4 weeks, 3 days a week, 60 minutes each time) with daily use of gabapentin (300 mg/day) or pregabalin (100 mg/day) for 4 weeks. The intervention consists of 4 sensory activities: stimulation of the sense of touch, recognition of the texture of objects, understanding the position of the limbs, and practice of two-point discrimination (ACTOVERCO Pharmaceutical Company). Control group: Daily use of gabapentin (300 mg/day) or pregabalin (100 mg/day) for 4 weeks (ACTOVERCO Pharmaceutical Company). Paresthesia intensity. Timepoint: Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention. Method of measurement: Visual Analog Scale. Balance. Timepoint: Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention. Method of measurement: Biodex balance SD. Proprioception. Timepoint: Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention. Method of measurement: Body position sense test. Two-point discrimination. Timepoint: Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention. Method of measurement: Sliding caliper. The texture of objects. Timepoint: Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention. Method of measurement: Testing the texture of objects with customized kit. Quality of life. Timepoint: Before the start of the intervention, immediately after the end of intervention course, 4 weeks after the end of the intervention. Method of measurement: Quality of Life questionnaire. Shiraz University of Medical Sciences Approved 2025-07-30 Ethics committee of Shiraz University of Medical Sciences Ethics committee, Research and Technology Vice-Chancellor, 7th floor, central building of Shiraz University of Medical Sciences, Zand Street Shiraz Fars Iran (Islamic Republic of)