Comparison of the effect of 6 weeks of balance & strength and hopping exercises on the kinematics of lower extremities in patients with functional ankle instability and Ankle-Sprain Copers Detected by Questionnaire (IdFAI)
The purpose of this study was to compare the effects of balance training and hoping on lower extremity kinematics in athletes with functional ankle instability and Cooper ankle sprain.
Design
Clinical trial with control group, with factorial groups,not blind, Stratified randomization
Settings and conduct
The study was carried out in the biomechanics laboratory of Yazd University, and the subjects were assigned to the laboratory on designated days and were photographed with cameras while running. Marking was also done. They were divided into five groups to practice the exercise protocol and were trained on different days and the groups did not know about each other's exercises.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Athlete who exercises regularly at least three times a week.2-Exercise at least once in the last 12 months of ankle sprain which has undergone its medical procedures.4-Physiotherapist's approval On the functional instability of the athlete's ankle
Exclusion criteria: 1) having neurological disorders 2) having lower extremity injury or ankle sprain last month
Intervention groups
Balance training group with functional ankle instability.
Balance training group with Coper ankle sprain.
Hopping exercises group with Coper ankle sprain.
Group of Hoping Exercises with Functional Ankle Instability.
Functional ankle instability group and coper ankle sprain without any exercise
Main outcome variables
Ankle joint kinematics; Knee joint kinematics; Hip kinematics.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190627044039N1
Registration date:2019-10-12, 1398/07/20
Registration timing:retrospective
Last update:2019-10-12, 1398/07/20
Update count:0
Registration date
2019-10-12, 1398/07/20
Registrant information
Name
Mohammad Hasan Kordi Ashkezari
Name of organization / entity
Shahid Bahonar University of Kerman
Country
Iran (Islamic Republic of)
Phone
+98 35 3272 2139
Email address
kordi.sport@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
2019-05-31, 1398/03/10
Actual recruitment end date
2019-06-21, 1398/03/31
Trial completion date
2019-09-06, 1398/06/15
Scientific title
Comparison of the effect of 6 weeks of balance & strength and hopping exercises on the kinematics of lower extremities in patients with functional ankle instability and Ankle-Sprain Copers Detected by Questionnaire (IdFAI)
Public title
Comparison of the effect of balance & strength and hopping exercises on the kinematics of lower extremities in patients with functional ankle instability and Ankle-Sprain Copers Detected by Questionnaire (IdFAI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
An athlete who exercises regularly at least three times a week.
He has experienced at least one external ankle sprain in the past 12 months, having undergone treatment.
Physiotherapist's confirmation of functional instability of the athlete's ankle
Age range from 16 to 40 years
Exclusion criteria:
Having neurological disorders
Having a lower limb injury or ankle sprain last month
Age
From 16 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
55
Actual sample size reached:
55
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is limited in this study. The method of implementing it is classified randomization, which is used to balance the number of random samples assigned within groups. This method is used to ensure sample size equilibrium between groups over time. After determining the block size by the researcher, the number of groups must also be specified. Then the number of people with the special code is put in the envelope. Mail envelopes will be merged and an envelope will be merged and re-merged. The first envelope falls into group 1, the second envelope in group 2, the third envelope in group 3, the fourth envelope in group 4, and the fifth in group 5. To hide the random assignment, the non-transparent wax seal envelope method will be used with a random sequence. After the random sequence based on the sample size, a number of packages will be prepared and each random sequence generated on the card will be recorded and the cards recorded. The envelopes are inserted in sequence in order to maintain a random sequence at the outer surface of the envelope, numbering is done in the same order and pasted into envelopes. At the beginning of the registration, one of the envelopes will be opened based on the participants' entry and the group will be announced.
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
veterinary faculty of shahid bahonar university of kerman
Street address
Veterinary Medicine faculty, shahid bahonar university, emen khomeini highway, kerman
City
kerman
Province
Kerman
Postal code
7616914111
Approval date
2019-05-27, 1398/03/06
Ethics committee reference number
IR.UK.VETMED.REC.1398.008
Health conditions studied
1
Description of health condition studied
functional ankle instability
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle
Primary outcomes
1
Description
kinematic of lower extremity
Timepoint
before of intervention and after six week intervention
Method of measurement
questionnaire and optitrack camera
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hoping Exercises: These exercises also come from the latest resources available for ankle joint rehabilitation. These exercises will last for 6 weeks and 3 weekly 45 minute sessions. These 45 minutes include 10 minutes warm-up 30 minutes core exercises and 5 minutes cool down. The tools used in this exercise are paper glues to show the direction of movement.
Category
Rehabilitation
2
Description
Control group: The group performs its daily activities and sports activities
Category
N/A
3
Description
Intervention group: Balance strengthening exercises: These are traditional exercises based on previous studies used for ankle sprain rehabilitation. These exercises will last for 6 weeks and 3 weekly 45 minute sessions. These 45 minutes include 10 minutes warm-up 30 minutes core exercises and 5 minutes cool down. The tools used in these exercises include a balance board and free weights and steppes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd University
Full name of responsible person
Farzad Feizi
Street address
Pejuhesh Ave., Daneshgah Blvd
City
Yazd
Province
Yazd
Postal code
8915818411
Phone
+98 35 3123 3291
Email
kordi.sport@gmail.com
2
Recruitment center
Name of recruitment center
Yazd Vaspur Club
Full name of responsible person
Mojtaba Zarenejad
Street address
22 Bahman Gym, Emam Ave, Emam Reza Sq, Ashkezar
City
Yazd
Province
Yazd
Postal code
8941684398
Phone
+98 35 3272 2139
Email
mzna68@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid bahonar university
Full name of responsible person
Mansur Sahebozamani
Street address
Emam khomeini
City
Kerman
Province
Kerman
Postal code
7616913439
Phone
+98 34 3132 3177
Email
sahebozamani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid bahonar 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
Yazd University
Full name of responsible person
Mohammad Hasan Kordi Ashkezari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
sport injury and corrective exercise
Street address
Taleghani
City
ashkezar
Province
Yazd
Postal code
8941684391
Phone
+98 35 3272 2139
Email
kordi.sport@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University
Full name of responsible person
Mohammad Hasan Kordi Ashkezari
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
sport injury and corrective exercise
Street address
taleghani
City
ashkezar
Province
Yazd
Postal code
8941684391
Phone
+98 35 3272 2139
Email
kordi.sport@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University
Full name of responsible person
Mohammad Hasan Kordi Ashkezari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
sport injury and corrective exercise
Street address
taleghani
City
ashkezar
Province
Yazd
Postal code
8941684391
Phone
+98 35 3272 2139
Email
kordi.sport@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
The data is confidential
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Can be used after non-identifying people
When the data will become available and for how long
3 months after publishing its articles
To whom data/document is available
People working in institutions and people in the industry
Under which criteria data/document could be used
To check the accuracy of work and research
From where data/document is obtainable
editor: Mohammad Hasan Kordi Ashkezari
email:kordi.sport@gmail.com
What processes are involved for a request to access data/document
The applicant can correspond by e-mail and after completing and publishing their service papers