Protocol summary

Study aim
Ankle is one of the most common joints that get injured in sports. This type of injury puts the athlete back from training sessions and competitions. Especially in sports such as football, basketball and other sports that require running, jumping and many landings. Also, due to the chain structure and connection of body parts, if this complication is not paid attention to, pain and other disorders in the knee area and ... involves a person. As a result, we study the effect of plyometric and combined exercises (neuromuscular-central stability) as rehabilitation in these people.
Design
The type of current research is experimental. The research model is a randomized clinical trial with a three-group design. The research design is intergroup pre-test - post-test. This research has three groups (control group, plyometric exercises group and combined exercises group (neuromuscular - central stability)). The sample size was purposefully estimated with G*Power 3.1.7 software (University of Dusseldorf, Germany) considering high power (0.8), average effect size (0.28) and alpha (0.05) of 30 patients.
Settings and conduct
The research was carried out in the physical training laboratory of Kharazmi University, Karaj branch. Treatment protocols are in groups for 8 weeks (three days per week and 40 minutes per day).
Participants/Inclusion and exclusion criteria
Score less than 24 in the Cumberland Ankle Stability Instrument (CAIT) 1: Any damage and abnormality affecting the research
Intervention groups
They are randomly divided into 3 groups, the first group is plyometric exercises with feedback, the second group is combined exercises (neuromuscular-central stability) and the third group is the control group that does not receive therapeutic intervention and engages in their daily and sports activities.
Main outcome variables
Identifying better exercise therapy for ankle instability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230914059431N1
Registration date: 2024-05-25, 1403/03/05
Registration timing: registered_while_recruiting

Last update: 2024-05-25, 1403/03/05
Update count: 0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
somayeh azizi
Name of organization / entity
Kharazmi university
Country
Iran (Islamic Republic of)
Phone
+98 41 3723 4406
Email address
azizisomaye049@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of a course of plyometric exercises with feedback and combined exercises (neuromuscular ، central stability) on maximum knee flexion angle, maximum vertical ground reaction force during landing and balance female athletes with chronic ankle instability
Public title
Investigating and comparing the effect of plyometric exercises with feedback with combined exercises (neuromuscular-central stability) on the maximum knee flexion angle,the maximum vertical ground reaction force in landing and balance.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female athlete Age range of 18-28 years Record of regular sports activity History of ankle injury in the last 5 years Score less than 24 in Cumberland Ankle Stability Instrument (CAIT)
Exclusion criteria:
History of ankle surgery in the last 1 year History of lower limb injury within the last week Postural stability problem caused by vestibular disorder Any damage and abnormality affecting the research Irregular attendance at training sessions
Age
From 18 years old to 28 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were divided into two groups based on the criteria for entering the research in a purposeful and simple random manner. Randomization is done based on blocks of four. A series of consecutive numbers that are generated by the number table in the computer. They are randomly placed in opaque envelopes, a person blind to patients and intervention groups performs randomization and assignment of numbers to groups. Also, patients in each group are blinded to the way of randomization and intervention performed in the other group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor and data analyst were kept blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
sport sciences research institute of iran
Street address
kharazmi University،Hesarak avenue
City
karaj
Province
Alborz
Postal code
3197937551
Approval date
2024-02-07, 1402/11/18
Ethics committee reference number
IR.SSRC.REC.1402.246

Health conditions studied

1

Description of health condition studied
chronic ankle instability
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Maximum knee flexion angle
Timepoint
Measurement of knee flexion one week before the intervention and one week after finishing the exercises
Method of measurement
3D motion analysis device

2

Description
Maximum vertical ground reaction force
Timepoint
Measurement one week before the intervention and one week after finishing the exercises
Method of measurement
Power plate device

3

Description
Balance
Timepoint
Measurement one week before the intervention and one week after finishing the exercises
Method of measurement
Biodex balance meter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Plyometric exercises with feedback. For 8 weeks, 3 sessions each week for 40 minutes
Category
Rehabilitation

2

Description
Intervention group:Combined exercises (neuromuscular and central stability) for 8 weeks, 3 sessions per week for 40 minutes
Category
Rehabilitation

3

Description
Control group: Control group 1: They do not have any training protocol and do their sports and daily activities
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Laboratory of Physical Education Faculty of Kharazmi University
Full name of responsible person
somayehazizi
Street address
Khwarazmi University-University Square_Hesarak Street
City
Karaj
Province
Alborz
Postal code
Phone
+98 914 421 5994
Email
azizisomaye049@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khwarazmi University
Full name of responsible person
Sadredinshojaedin
Street address
Kharazmi University_University Square-At the end of Shahid Beheshti Street
City
Karaj
Province
Alborz
Postal code
Phone
+98 912 507 3897
Email
sa_shojaedin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khwarazmi University
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
Kharazmi University
Full name of responsible person
sadredinshojaedin
Position
science committee
Latest degree
Ph.D.
Other areas of specialty/work
sport pathology and co
Street address
kharazmi University HesarakSt
City
karaj
Province
Alborz
Postal code
3197937551
Phone
+98 912 507 3897
Email
Sa_shojaedin@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sport Sciences Research Institute of Iran
Full name of responsible person
Mojtaba Ashrostaghi
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Sports biomechanics
Street address
Shahzade Qasim4 the alley , Imam street
City
Gorgan
Province
Golestan
Postal code
4918688141
Phone
+98 17 3222 7388
Email
mojtabaashr@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Somayeh Azizi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Sport pathology
Street address
House number21.Nojavan the alley.Sasan St
City
Maraghe
Province
East Azarbaijan
Postal code
5514868475
Phone
+98 41 3723 4406
Fax
Email
azizisomaye049@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
1 month after printing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Academic research only
From where data/document is obtainable
azizisomaye049@gmail.com
What processes are involved for a request to access data/document
After receiving the email, the research will be sent 1-2 days later
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