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IRCT20240111060675N1 IRCT 2024-01-29 Ahvaz University of Medical Sciences Comparing the effect of two types of exercises on balance control in individuals with diabetic neuropathy Comparing the effects of one session of perturbation-based balance training with block and random sequences on reactive balance control in individuals with diabetic neuropathy 2024-01-21 anticipated 60 Complete https://irct.ir/trial/75036 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After checking the inclusion criteria, people are divided into three groups using Stratified Permuted Block randomization method.Using this randomization method, people will be classified according to gender. The advantage of this method is that while keeping the number of people in the three groups equal, the balance of the groups will also be maintained in terms of the dispersion of the influencing variables (gender in this study). For this purpose, a random order of three letters A (intervention with random approach), B (intervention with blocked approach) and C (control) is made in groups of 6 by random assignment computer software. Then the batches are hidden by opaque envelopes, Blinding description: The assessor will not be aware of the type of grouping of receiving treatment methods of the participants. N/A Type 2 diabetes and diabetic peripheral neuropathy. Intervention 1: The blocked group receives perturbation-based balance training in one session in the form of 6 sets and each set with 4 repetitions, a total of 24 repetitions of perturbation with blocked sequence. Intervention 2: The random group receives perturbation-based balance training in one session in the form of 6 sets and each set with 4 repetitions, a total of 24 repetitions of perturbation with a random sequence. Intervention 3: The control group will not receive any training. But they will receive all evaluations exactly the same as other groups. 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 -

public Razieh Javadian Kootenaie

Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Ahvaz Iran (Islamic Republic of) - +98 61 1374 3101 javadian.razieh@yahoo.com Ahvaz University of Medical Sciences scientific Razieh Javadian Kootenaie

Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Ahvaz Iran (Islamic Republic of) - +98 61 1374 3101 javadian.razieh@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Having type 2 diabetes and diabetic peripheral neuropathy based on clinical and laboratory diagnostic criteria as diagnosed by an endocrinologist Age range between 45-60 years Ability to stand independently for 30 minutes Obtaining a neuropathy deficit score higher than 3 and less than or equal to 6 between 3 and 6 Ability to read and write in Persian Obtaining Minimum score of 24 on mini-mental State Examination (MMSE) 45 years 60 years Both Foot ulcer and amputation (Complete and incomplete) Any orthopedic problems or a history of surgery in the lower limbs that interferes with walking and standing, and a history of sprained ankles in the last year and skeletal-muscular deformities in the lower limbs Severe pain in the soles of the feet caused by diabetic neuropathy Symptoms of central nervous system involvement such as dementia, Parkinson's and multiple sclerosis and a history of stroke Uncorrected vision problems Hearing problem History of vertigo Report of peripheral vascular problems and heart problems, including a history of unstable angina, uncontrolled blood pressure, and a history of resting tachycardia or arrhythmia Professional or regular exercise for at least 6 months before the study Taking anti psychotic and anti-anxiety drugs Suffering from major depression based on the score of the modified version of the short Beck Depression Inventory above 18 E11 Type 2 diabetes mellitus Rehabilitation Rehabilitation Rehabilitation The blocked group receives perturbation-based balance training in one session in the form of 6 sets and each set with 4 repetitions, a total of 24 repetitions of perturbation with blocked sequence. The random group receives perturbation-based balance training in one session in the form of 6 sets and each set with 4 repetitions, a total of 24 repetitions of perturbation with a random sequence. The control group will not receive any training. But they will receive all evaluations exactly the same as other groups. Reactive balance. Timepoint: Baseline, immediately after intervention and 24 hours after the end of the intervention. Method of measurement: Computerized dynamic posturography device. Static balance. Timepoint: Baseline. Method of measurement: Functional Reach clinical test. Balance Confidence. Timepoint: Baseline. Method of measurement: Activities Specific Balance Confidence questionnaire. Dynamic balance. Timepoint: Baseline. Method of measurement: Mini-BES Test questionnaire. Ahvaz University of Medical Sciences Approved 2024-01-06 Ethics committee of Ahvaz Jundishapur University of Medical Science Ground floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Science Ahvaz Khouzestan Iran (Islamic Republic of)