Protocol summary

Study aim
Comparison of The effect of a period Wobble board training with and without Cognitive intervention on balance, ankle proprioception, and some jump landing kinetic parameters of the active men with chronic ankle instability
Design
The present study consisted of 21 active men with chronic ankle instability who were targeted (according to the Inclusion and exclusion criteria and using the FADI and FADI-S questionnaire and with the approval of a physician. ) Are selected and randomly divided into three groups of 7: controls, Wobble board Exercises and Wobble board Exercises with Cognitive Intervention
Settings and conduct
21 patients with chronic ankle instability were randomly divided into 3 intervention and control groups. The two experimental groups performed their exercises for 5 weeks and 3 sessions per week by warming and cooling before and after exercise.
Participants/Inclusion and exclusion criteria
Inclusion criteria Active men between the ages of 18 and 25, BMI between 18 and 25, a history of at least 2 reports of giving way in the last 6 months, the last injury occurred more than 6 weeks before the start of the study, A history of at least one significant ankle lateral spray on one side that has caused pain and decreased function for more than a day. Exclusion criteria History of vestibular or neuro-musculoskeletal disorders, history of lower limb surgery, lower limb injury for at least 6 months prior to this study, having abnormalities Musculoskeletal system in the lower extremities such as flat feet, genu varum, physiotherapy or participation in physical rehabilitation in the last 3 months.
Intervention groups
Three groups of seven people wobble board exercises, wobble board exercises with Cognitive intervention and control group
Main outcome variables
Balance, Ankle proprioception, and some jump landing kinetic parameters of the active men with chronic ankle instability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200617047818N1
Registration date: 2021-02-05, 1399/11/17
Registration timing: retrospective

Last update: 2021-02-05, 1399/11/17
Update count: 0
Registration date
2021-02-05, 1399/11/17
Registrant information
Name
Abed Taghavi asl
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 74 4236 2769
Email address
std_abed_taghaviasl@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-10, 1399/09/20
Expected recruitment end date
2020-12-30, 1399/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Effect of a period Wobble Board training with and without Cognitive intervention on balance, ankle proprioception, and some jump landing kinetic parameters of the active men with chronic ankle instability
Public title
Comparison of The Effect of Wobble board training with and without Cognitive intervention on the active men with chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Active men between 18 and 25 years old. BMI is between 18 and 25. History of at least 2 reports of giving way in the last 6 months. The last injury occurred more than 6 weeks before the start of the study. Ability to bear weight on the injured limb. (Finally have a slight feeling of discomfort.) History of at least one significant ankle sprain on one side that has caused pain and decreased function for more than a day.
Exclusion criteria:
History of vestibular or neuro-musculoskeletal disorders. History of lower limb surgery. Lower limb injury for at least 6 months prior to this study. Use of medications that affect balance, such as betahistine and blood pressure and sedative medications. Having musculoskeletal abnormalities in the lower extremities such as flat feet, genu varum. physiotherapy or participating in physical rehabilitation in the past 3 months.
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 21
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized into one of three groups (Two intervention and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kinesiology Research Center
Street address
Keshvari Educational Sport Complex, South Razan Ave., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
15447-33111
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.SSRC.REC.1399.119

Health conditions studied

1

Description of health condition studied
Chronic ankle instability
ICD-10 code
M25.37
ICD-10 code description
Other instability, ankle and foot

2

Description of health condition studied
Athlete
ICD-10 code
Y93
ICD-10 code description
Activity codes

Primary outcomes

1

Description
Balance
Timepoint
Before the intervention and after the last intervention session.
Method of measurement
Dynamic balance with Y balance test and static balance with balance error scoring system.

2

Description
Ankle proprioception
Timepoint
Before the intervention and after the last intervention session.
Method of measurement
Subjects' ankles are evaluated using an isokinetic device in the reconstruction of two positions of 15 degrees of inversion and a maximum inversion of minus 5 degrees.

3

Description
Some jump landing kinetic parameters
Timepoint
Before the intervention and after the last intervention session.
Method of measurement
Ground reaction force information during jump-landing task is recorded using force plate (Kistler, Winterthor, Switzerland, 1000 Hz).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For 5 weeks, three sessions per week, 5 sets, each set 40 seconds, every 10 seconds to rotate alternately, one minute rest between each set, standing in three positions: standing, standing on non-engaged leg, and standing on foot Involved, wobble board exercises
Category
Rehabilitation

2

Description
Intervention group: For 5 weeks, three sessions per week, 5 sets, each set 40 seconds, every 10 seconds to rotate alternately, one minute rest between each set, standing in three positions: standing, standing on non-involved foot, and standing on foot Involved, wobble board exercises with seven countdowns from a random number between 200 and 300
Category
Rehabilitation

3

Description
Control group: This group carries out its daily value activities.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Institute of Physical Education and Sports Sciences
Full name of responsible person
Abed Taghavi Asl
Street address
No. 3, Fifth Alley, Mir Emad St., Ostad Motahhari St., Tehran
City
Tehran
Province
Tehran
Postal code
1587958711
Phone
+98 21 8874 7884
Email
info@ssrc.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Vice-chancellor for Research and Technology
Street address
No. 43, 10th Floor of Office Building, Shahid Mofteh St., Tehran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8607 0779
Email
research@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi University
Proportion provided by this source
30
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
Kharazmi University
Full name of responsible person
Abed Taghavi Asl
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
14 Shahed Alley, Suq Town
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7573114383
Phone
+98 74 4326 2769
Email
ataghaviasl72@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Seyed Sadradin Shojaedin
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Rehabilitation
Street address
Keshvari Educational Sport Complex, South Razan Ave., Mirdamad Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۵۴۴۷۳۳۱۱۱
Phone
+98 26 3451 2001
Email
shojaeddin@khu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Abed Taghavi Asl
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
14 Shahed Alley, Suq Town
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7573114383
Phone
+98 74 4326 2769
Email
ataghaviasl72@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
With the approval of the Supervisor, all information can be shared after being unidentified.
When the data will become available and for how long
6 months after publishing the results in the articles and obtaining permission from the relevant university
To whom data/document is available
There is no limit.
Under which criteria data/document could be used
There are no restrictions except for personal data.
From where data/document is obtainable
To the person in charge of this research, Mr. Abed Taghavi Asl
What processes are involved for a request to access data/document
Contact Mr. Abed Taghavi Asl and coordination with the supervisor and the Department of Sports Pathology, Kharazmi University of Tehran, information can be provided.
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