The effect of eight weeks of gluteal muscle strengthening exercises on Sensorimotor Function, balance and ankle instability in women with chronic ankle instability
The effect of eight weeks of gluteal muscle strengthening exercises on Sensorimotor Function, balance and ankle instability in women with chronic ankle instability
Design
A clinical trial with a control group with parallel groups, without blinding, randomized with the ranb function of Excel software, on 30 subjects.
Settings and conduct
After filling the CAIT questionnaire by the students of Shahrekord University and obtaining a score of less than 24, the students will be taken to the physiology laboratory and the weakness of the middle and large gluteal muscles will be examined. Then, eligible and volunteer participants in this study will be randomly divided into two intervention and control groups. The intervention group will do their exercises for eight weeks, three sessions a week at Shahrekord University Club. After eight weeks, the evaluations will be repeated again.
Participants/Inclusion and exclusion criteria
History of ankle sprain in the last 2 years
Having at least two ankle sprains in the last 6 months
Getting a score from the post-test (score zero to 24 of the Cumberland CAIT questionnaire)
non-athlete
Voluntary consent of the subjects
Weakness of the middle palate
Great satire weakness
Female students aged 18 to 40
No history of surgery
No history of fracture
No history of neurological diseases
Not using drugs that affect the nervous system, such as sedatives, on the day of the test
No balanced hearing problems
No pain in any part of the body
Intervention groups
An intervention group
A control group
Main outcome variables
Sensorimotor function, balance, ankle instability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231022059811N1
Registration date:2023-11-06, 1402/08/15
Registration timing:prospective
Last update:2023-11-06, 1402/08/15
Update count:0
Registration date
2023-11-06, 1402/08/15
Registrant information
Name
maedeh kafami ladani
Name of organization / entity
The university of shahrekord
Country
Iran (Islamic Republic of)
Phone
+98 31 3772 0619
Email address
maedehkafami77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2024-01-15, 1402/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of gluteal muscle strengthening exercises on Sensorimotor Function, balance and ankle instability in women with chronic ankle instability
Public title
The effect of gluteal muscle strengthening exercises on ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of ankle sprain in the last 2 years
Having at least two ankle sprains in the last 6 months
Obtaining a score from the questionnaire (score zero to 24 of the Cumberland CAIT questionnaire)
non-athlete
Voluntary consent of the subjects
Weakness of the gluteus medius
Weakness of the gluteus maximus
Female students aged 18 to 40
No history of surgery
No history of fracture
No history of neurological diseases
Not using drugs that affect the nervous system, such as sedatives, on the day of the test
No balanced hearing problems
No pain in any part of the body
Exclusion criteria:
No history of ankle sprain in the last 2 years
Not having at least two ankle sprains in the last 6 months
Failure to obtain a grade from the transcript (CAIT more than 24)
athlete
Lack of voluntary consent of subjects
Absence of weakness of gluteus medius
Absence of weakness of gluteus maximus
Female or male students less than 18 or more than 40
History of surgery
History of fracture
History of neurological diseases
Using drugs that affect the nervous system, such as sedatives, on the day of the test
Pain in any part of the body
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization
Randomization Unit: Individual
Randomization tools: Lottery using cards and bowls
How to create a random sequence and concealment: First, the names of 30 students with ankle instability and weakness of the middle and large pelvis were written on a sheet as a statistical population, and the sheets were folded and thrown into a bowl. Then I separate two bowls and put one of the papers in one bowl and the other paper in the other bowl and continue doing this until the last paper and in the end there are 15 papers in each bowl, one of the bowls is the intervention group and the other is the intervention group. We will choose control.
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 Shahrekord University
Street address
University Shahrekord, Rahbar Blvd
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Approval date
2023-06-12, 1402/03/22
Ethics committee reference number
IR.SKU.REC.1402.014
Health conditions studied
1
Description of health condition studied
ankle sprain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cumberland questionnaire and gluteal muscle weakness
Timepoint
Pre-test and post-test
Method of measurement
The method of measuring gluteal weakness is done by hand dynamometer, and subjects should score less than 24 in the Cumberland Questionnaire.
Secondary outcomes
1
Description
Sensorimotor function, balance, ankle instability
Timepoint
Pre-test and post-test
Method of measurement
How to measure sensorimotor function with a goniometer, balance is measured by static and dynamic tests with a stopwatch, and ankle instability is measured with the dentification of function ankle instability questionnaire.
Intervention groups
1
Description
Intervention group: They will do gluteal strengthening exercises for 8 weeks, 3 sessions per week and 30 minutes each session. Each exercise has 8 repetitions, each movement is performed with a 2 second pause and 2 minutes of rest between each exercise. After 4 weeks, by adding weight to each of the exercises, the level of muscle activation can be increased, which causes more strengthening effects.
Category
Rehabilitation
2
Description
Control group: There was no intervention and they went about their daily lives.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord University
Full name of responsible person
maedeh kafami ladani
Street address
Shahrekord University, Rahbar Blvd
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 31 3772 0619
Email
maedehkafami77@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University
Full name of responsible person
maedeh kafami ladani
Street address
Shahrekord University, Rahbar Blvd
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 31 3772 0619
Email
maedehkafami77@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University
Proportion provided by this source
50
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
The University of Shahrekord
Full name of responsible person
Maedeh kafami ladani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Sports science
Street address
University Shahrekord, Rahbar Blvd
City
Sahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 31 3772 0619
Email
maedehkafami77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Maedeh kafami ladani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports science
Street address
Shahrekord University, Rahbar Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 31 3772 0619
Email
maedehkafami77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Maedeh kafami ladani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Sports science
Street address
Shahrekord University, Rahbar Blvd
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 31 3772 0619
Email
maedehkafami77@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
People's information will remain confidential and I only have the right to publish the results as a group.