Comparison of EMG-NCV characteristics between the two groups
Design
After giving the necessary explanations, written consent is obtained from the mentioned patients, and then they are treated with balance or aerobic exercises in one of the two groups in a simple random manner and in a block method.
Settings and conduct
This is randomized clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria include diabetics patient between the ages of 30 and 65 who are able to stand and walk independently without any assistive devices, and Electrodiagnostic tests have confirmed the presence of diabetic Neuropathy. Exclusion criteria include people with diabetic foot ulcers, uncontrolled blood sugar, inner ear infection, neurological diseases (other than neuropathy) or other disorders of balance, a history of recurrent ankle sprains in the past year, severe pain It is a disturbance of balance and the presence of any disturbing factor of balance other than diabetic neuropathy.
Intervention groups
Diabetic patients are divided into two groups of balance and aerobic exercise. Before the intervention, patients are tested for EMG-NCV and then they are given balance or aerobic exercise 3 days a week for 8 weeks. After 8 week EMG-NCV tests are taken again from patients.
Main outcome variables
Comparison of emg-ncv characteristics in diabetic patients into two groups of balance and aerobic exercise
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039324N4
Registration date:2021-12-01, 1400/09/10
Registration timing:prospective
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Sirous Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 3476
Email address
s.azizi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-17, 1400/09/26
Expected recruitment end date
2022-04-23, 1401/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of balance exercise in comparison with aerobic exercise on electro diagnostic parameters in patient with diabetic peripheral neuropathy
Public title
Effectiveness of balance exercise in comparison with aerobic exercise on electro diagnostic parameters in patient with diabetic peripheral neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetics patient between the ages of 30 and 65
are able to stand and walk independently without any assistive devices,
are able to walking independently without any assistive devices,
electrodiagnostic tests have confirmed the presence of diabetic neuropathy
Exclusion criteria:
Diabetic ulcers in the legs,
uncontrolled blood sugar,
inner ear infection,
neurological diseases (other than neuropathy) or other disorders of balance,
history of recurrent ankle sprains in the past year,
severe disturbing balance
presence Any factor that disturbs the balance other than diabetic neuropathy
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to balance or aerobic exercise in one of two groups using block randomization. To randomly assign two groups with 33 participants in each group (66 patients in total), we use block randomization with different block sizes. The size of the blocks is a multiple of 3 and a divisor of 66 (3,6,9). Initially, the size of the blocks is randomly selected. Then for each block, different permutations are determined for the size of the equal group. Finally, one of the permutations is randomly selected. Random numbers are generated using a computer in an independent statistical unit.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mical university for the islamic republic of iran s Army