Investigating the effect of cognitive exercises with and without whole body vibration on balance indicators in type 2 diabetes patients with moderate peripheral neuropathy
Design
Three arm parallel group randomized trial with blinded assessor on 36 diabetic patients. Randomization is used Card punching method
Settings and conduct
The statistical population of the study is type 2 diabetes patients with neuropathy symptoms who refer to the diabetes clinic of Imam Hossein Hospital, who are referred to the rehabilitation faculty of Shahid Beheshti University of Medical Sciences. People who meet the entry criteria are placed in the treatment group: 1. Cognitive exercises only, 2- Whole body vibration group along with cognitive exercises and 3- Common treatment of balance exercises.The method of choosing patients non-randomly will be simple and accessible. While their placement in treatment groups is done randomly. Variables are evaluated before, after 10 treatment sessions and 6 weeks of follow-up. Also, in order to avoid any errors in the method of measuring the patients' indicators, all measurements are done by the physiotherapist who was not aware of the positioning of the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
At least 1 year of type 2 diabetes
Neuropathy score between 13 and 29 based on the Michigan questionnaire
Tibial nerve conduction velocity between 32-38 m/s
Exclusion criteria:
Diabetic infectious wounds
Knee or hip prosthesis
History of epilepsy
Intervention groups
The studied groups include two treatment groups and one control group as follows:
1- The treatment group with cognitive exercises, 2- The treatment group with cognitive exercises along whole body vibration, and 3- The control group or common treatment with balance exercises
Main outcome variables
Functional balance
Static balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190726044337N2
Registration date:2024-08-10, 1403/05/20
Registration timing:registered_while_recruiting
Last update:2024-08-10, 1403/05/20
Update count:0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Maryam Niajalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4222 4593
Email address
maryam_niajalili@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive practice with and without whole body vibration on balance indicators in type 2 diabetic patients with peripheral neuropathy
Public title
The effect of mental exercises on the balance of diabetic patients with neuropathy symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 1 year of type 2 diabetes
Neuropathy score between 13 and 29 based on the Michigan questionnaire
Tibial nerve conduction velocity between 32-38 m/s
The score of the mental state test questionnaire is between 23 and 28
Exclusion criteria:
Infectious diabetic wounds
Knee or hip prosthesis
Active implants
History of epilepsy
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
36
More than 1 sample in each individual
Number of samples in each individual:
2
Both legs with peripheral neuropathy
Randomization (investigator's opinion)
Randomized
Randomization description
-Randomization method and description of each method: simple randomization, block
-Randomization Unit: Individual
-Randomization Tool: Shuffle the cards
-The sequence is made in such a way that an equal number of cards are considered as the first group and the same number of cards for the other groups, then by merging the cards, one card is removed and after allocating it, it is added to the other cards. is returned. This process continues until reaching a random sequence corresponding to the sample size.
-Concealment of random allocation is done by placing the cards in non-transparent and sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
،his study is a single-blind study. In this way, only the physiotherapist evaluating the indicators was not aware of how the patients were placed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Faculty of Rehabilitation of Shahid Beheshti University of Medical Sciences, In front of Bu Ali Hospital, Imam Hossein Square, Damavand St
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2023-11-28, 1402/09/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.491
Health conditions studied
1
Description of health condition studied
Diabetic Neuropathy
ICD-10 code
E11.43
ICD-10 code description
Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy
Primary outcomes
1
Description
Static balance score in 4-stage balance test
Timepoint
Before starting the intervention, after 10 treatment sessions and after 6 weeks of follow-up
Method of measurement
4-stage balance test
Secondary outcomes
1
Description
Quality of life score
Timepoint
Before starting the study, after 10 treatment sessions and 6 weeks of follow-up
Method of measurement
SF-36 questionnaire
Intervention groups
1
Description
Intervention group: During 10 treatment sessions, patients in this group receive skin surface stimulation from the 733x stimulator model of Novin Medical Engineering Company on the back of the leg and plantar area of the foot with a frequency of 150 Hz and a duration of 250 microseconds for 20 minutes. In this way, two electrodes are placed along the plantar area of the foot and two other electrodes are placed in series on the back of the patient's leg. Then patients perform common exercises in each session in the form of balance exercises and proprioceptive strengthening for 30 minutes in 5 repetitions with a 45-second rest. In the following, people treated with memory-activating cognitive exercises include counting numbers from 50 to earlier, memorizing the words of the therapist and the order of their expression, calculating numbers from simple to advanced and verbal communication between the patient and the therapist through the question and answer process
Category
Rehabilitation
2
Description
Intervention group: During 10 treatment sessions, patients in this group receive skin surface stimulation from the stimulator model 733x of Novin Medical Engineering Company on the back of the leg and plantar area of the foot with a frequency of 150 Hz and a duration of 250 microseconds for 20 minutes. In this way, two electrodes are placed along the plantar area of the foot and two other electrodes are placed in series on the back of the patient's leg. Then patients perform common exercises in each session in the form of balance exercises and proprioceptive strengthening for 30 minutes in 5 repetitions with a 45-second rest. In addition, the device receives whole body vibration with a frequency of 30 Hz and an amplitude of 2 mm along with cognitive exercises simultaneously in the form of dual therapy. In this way, the patients keep their knees bent up to 30 degrees with the condition of maintaining balance, and at the same time, they benefit from the mentioned cognitive exercises. These steps are repeated 6 times with a 1-minute rest between each step
Category
Rehabilitation
3
Description
Control group: Patients in this group only receive skin surface stimulation for 20 minutes from the 733x stimulator model of Novin Medical Engineering Company on the back of the leg and plantar area of the foot with a frequency of 150 Hz and a duration of 250 microseconds during 10 treatment sessions. In this way, two electrodes are placed along the plantar area of the foot and two other electrodes are placed in series on the back of the patient's leg. Then patients perform common exercises in each session in the form of balance exercises and proprioceptive strengthening for 30 minutes in 5 repetitions with a 45-second rest