Comparison of the effect of proprioception practice and auriculotherapy on the balance and proprioception of lower extremity in patients with diabetic neuropathy
Determining and Comparison of the effect of proprioception practice and auriculotherapy on the balance and proprioception of lower extremity in patients with diabetic neuropathy
Design
Clinical trial with control group, with parallel, non-blind, randomized groups, 69 people
Settings and conduct
Patients with diabetic neuropathy referred to Shahid Mofteh Yasuj Educational and Medical Clinic No. 4. At the beginning of the study, demographic characteristics questionnaires, Michigan neuropathy to diagnose diabetic neuropathy and the use of Toronto Clinical Scoring System to classify the severity of neuropathy to mild, moderate and severe. Then perform the intervention using the Star and Base test to check the dynamic and static balance and use the goniometer tool to assess the proprioception as well as perform auriculotherapy using Vacaria seeds.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Diabetes based on the diagnosis of a specialist
2. Diabetic neuropathy based on Michigan questionnaire
Output criteria:
1. Existence of deformity or neurological and rheumatic diseases in the lower extremities
2. Existence of foot ulcers and no report of history of dizziness and ankle sprains
Intervention groups
The three intervention groups include proprioception practice, auriculotherapy, and control. In the proprioception practice group, the exercises are performed for 6 weeks and 3 sessions per week, 30 minutes per session and a total of 18 sessions as a group to match the place and time for patients. In the auriculotherapy group, 10 sessions are performed twice a week for a total of 5 weeks. There is no training in the control group.
Main outcome variables
Balance and proprioception
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047260N1
Registration date:2020-05-26, 1399/03/06
Registration timing:registered_while_recruiting
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Nayereh Ghazavi Khorasgani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3521 0921
Email address
nayer.uni@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-12, 1398/12/22
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of proprioception practice and auriculotherapy on the balance and proprioception of lower extremity in patients with diabetic neuropathy
Public title
Comparison of the effect of proprioception practice and auriculotherapy on the balance and proprioception of lower extremity in patients with diabetic neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes based on the diagnosis of a specialist
Diabetic neuropathy based on Michigan questionnaire
Ability to communicate and answer questions
Be at least 18 years old and at most 65 years old
Satisfaction to participate in the study and signing of the Conscious Consent Form
Exclusion criteria:
Existence of deformity or neurological and rheumatic diseases in the lower extremities
Existence of foot ulcers and no report of history of dizziness and ankle sprains
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants in the study are selected from among the available individuals. Once selected, participants will be assigned a random blockchain allocation between the three groups. Eligible individuals will be assigned admission criteria after obtaining informed consent, using the List Randomization site and creating a number of different blocks.
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 Yasuj University of Medical Sciences
Street address
Yasuj, Shahid Motahari Blvd., Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2020-03-11, 1398/12/21
Ethics committee reference number
IR.YUMS.REC.1399.025
Health conditions studied
1
Description of health condition studied
Diabetic Neuropathy
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Balance
Timepoint
Equilibrium at the beginning of the study (before the start of the intervention) and after the start of the study
Method of measurement
Star Excursion Balance Test(SEBT) & Balance Error Scoring System test(BESS) & Vaccaria seed
2
Description
Proprioception
Timepoint
Proprioception at the beginning of the study (before the intervention begins) and after the study begins
Method of measurement
Goniometer & Vaccaria seed
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: proprioception practice : Exercises for 6 weeks and 3 sessions per week, each session for 30 minutes and a total of 18 sessions as a group to match the place and time, for patients. The sessions will begin with warm-up exercises for 5 minutes. Warming-up activities include: walking back and forth, running softly and slowly, and performing stretching exercises for different parts of the body, as well as cooling down at the end of the workout. The main proprioception practice include: 1- Maintaining the position: standing on one leg, jumping to the sides and forward - backward. 2- Strength: Strengthening the front of the thigh, back of the thigh, squat and the sides of the thigh. 3- Plyometric: jumps (single-legged - two-legged, rotations 90 and 180 degrees). 4- Speed and agility exercises: running figure 8, running forward - Back and sides (straight and spiral paths). The intensity of the exercises will be adjusted based on the patients' abilities. The number and duration of exercises will be the same in the first two sessions and will then change according to the patients' abilities. Rest time between exercises will be as much as changing position and being in a new position. All tests, like the pre-test, will be performed 48 hours after completing the 6-week training protocol and the results will be recorded.
Category
Rehabilitation
2
Description
Second Intervention Group: auriculotherapy: In this group, patients are taught the required information such as the purpose of the work, the time required to pressurize the desired points, the number of times a day and the length of the auriculotherapy course are also taught to patients. The adhesive of the auriculotherapy seeds, please contact the researcher's phone number given to them so that the seeds can be repositioned on the previous point. The researcher begins auriculotherapy using the Vaccaria seed adhesive at the points designated for the intervention group. The samples were taken 2 times a week for 10 sessions and a total of 5 weeks treated with Vaccaria seed adhesive on the equilibrium points. Both ears are located in the right ear, including the equilibrium point, Thalamic point, Lumbago point, and in the left ear, including Shenmen's point, pancreatic point, and Hippocampus point, and these adhesives are removed by the researcher every 3 days. And at least 1 to 2 hours later (for the rest of the ear, the adhesives are removed for 1 to 2 hours) again, a glue with Vaccaria seed No longer connected. After the intervention sessions, the level of balance and depth is measured again by the researcher. The results are reviewed and statistical analysis is performed according to the research objectives. During this time, 3 phone calls will be made to each patient to answer questions and resolve any potential issues. The results are reviewed in two stages before and after the intervention and statistical study is performed according to the research objectives.
Category
Rehabilitation
3
Description
Control group: No intervention: This training group will not be given.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofteh Yasuj Educational and Medical Clinic No. 4
Full name of responsible person
Ghazavi Khorasgani
Street address
No. 67, 13th Alley, Masjed Ali St., Jay St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8156173811
Phone
+98 31 3521 0921
Email
nayer.uni@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari Oryad
Street address
Yasuj., Shahid Motahari Blvd., Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591977833
Phone
+98 74 1333 7251
Email
Oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nayereh Ghazavi Khorasgani
Position
M.S student of internal surgery nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 67, 13th Alley, Masjed Ali St., Jay St., Esfahan
City
Esfahan
Province
Kohgilouyeh-va-Boyrahmad
Postal code
8156173811
Phone
+98 31 3521 0921
Email
nayer.uni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nayereh Ghazavi Khorasgani
Position
M.S student of internal surgery nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 67, 13th Alley, Masjed Ali St., Jay St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8156173811
Phone
+98 31 3521 0921
Email
nayer.uni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nayereh Ghazavi Khorasgani
Position
M.S student of internal surgery nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 67, 13th Alley, Masjed Ali St., Jay St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8156173811
Phone
+98 31 3521 0921
Email
nayer.uni@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available