Protocol summary

Study aim
Evaluation of the effect of 6 weeks of hop exercises and agility ladder exercises on dynamic balance using star balance test and functional tests in people with chronic ankle instability.
Design
Samples are randomly assigned to one of the two groups of agility ladder exercises and hop exercises equally by the restricted randomization and law of random allocation (drawing a card from the number of cards equal to the sample size (30 people) The trial design will be done in parallel.
Settings and conduct
This study includes two types of agility ladder and hop exercises that are given to participants with chronic ankle instability for 6 weeks and 3 times a week, Accurate evaluation is done before and after 6 weeks, functional tests are taken to evaluate the effectiveness of the exercises. Before starting the exercises, the person does warm-up exercises, and then the main treatment exercises and finally cooling down.
Participants/Inclusion and exclusion criteria
Inclusion criteria: In the age range of 18 to 35 years. Regular exercise 3 days a week. At least one ankle sprain that has caused pain, swelling, and dysfunction for more than a year . At least two episodes in the last 6 months. 90% or less score in FAAM questionnaire . Exclusion criteria: Ankle sprains in the last 6 weeks. Ankle surgery Vision problems . Neurological problems that cause imbalance Lower limb fractures.
Intervention groups
Intervention group: Hop exercises are a modified type of plyometric exercises. These exercises also improve dynamic balance. Hop exercises are a type of exercise that is similar to basic and dynamic movements in many sports. Agility ladder is used in various sports to improve performance, improve acceleration, speed, coordination, dynamic balance, static and maintain body posture.
Main outcome variables
Improve dynamic balance and ankle function in people with chronic ankle instability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180728040618N4
Registration date: 2021-06-01, 1400/03/11
Registration timing: prospective

Last update: 2021-06-01, 1400/03/11
Update count: 0
Registration date
2021-06-01, 1400/03/11
Registrant information
Name
Holakoo Mohsenifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 6933
Email address
mohsenifar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-03-12, 1400/12/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of agility ladder and hop training exercises on dynamic balance and functional tests in semi professional athletes with chronic ankle instability
Public title
The effect of agility ladder and hop training exercises on chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 18 to 35 years. 3 days a week and have 1 hour of regular exercise each time. At least one ankle sprain that has caused pain, swelling, and dysfunction for more than a year. Have episodes of twisting and frequent giving way and have at least two episodes in the last 6 months. Unilateral ankle sprain . 90% or less score in FAAM questionnaire.
Exclusion criteria:
Ankle sprains in the last 6 weeks. Ankle surgery. Vision problems. Neurological problems that cause imbalance, including: Parkinson's and multiple sclerosis and stroke. Lower limb fractures. Participants do not want to continue participating in the study due to pain or any unforeseen event. Acute musculoskeletal problems in the last 3 months (strains and tears of muscles and tendons, knee ligament injury and knee meniscus injury). Consumption of psychotropic drugs: benzodiazepines, antipsychotics, antidepressants. Alcoholism. genu recurvatum.
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are randomly assigned to one of the two groups of agility ladder exercises and hop exercises equally by the restricted randomization and law of random allocation (drawing a card from the number of cards equal to the sample size and entering a group of two groups
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-05-17, 1400/02/27
Ethics committee reference number
IR.IUMS.REC.1400.168

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

Primary outcomes

1

Description
Dynamic balance
Timepoint
Determining the reach distance in the star balance test before the intervention and after 6 weeks of hop exercises and agility ladder exercises
Method of measurement
In the star balance test, a person can reach a greater distance with a non-involved foot.

Secondary outcomes

1

Description
Determining the number of hop to the side in 30 seconds at a distance of 40 cm
Timepoint
Determining the number of hop to the side in 30 seconds at a distance of 40 cm, before the intervention and after the 6-week intervention hop exercises and agility ladder exercises.
Method of measurement
Chronometer for time of side hop test

2

Description
Determining the time of multiple hop
Timepoint
Before the intervention and after the 6-week intervention hop and agility ladder exercises
Method of measurement
Chronometer for time of multiple hop test

3

Description
Foot and ankle ability measurement
Timepoint
Before the intervention and after the intervention 6 weeks of hop training and agility ladder training
Method of measurement
Foot and ankle ability measurement questionaries

Intervention groups

1

Description
Hop exercises are a modified version of plyometric exercises and have recently been used to reduce ankle instability. These exercises are relatively inexpensive, so it is easy to use in exercises. These exercises also improve dynamic balance .Hop exercises are a type of exercise that is similar to basic and dynamic movements in many sports. It also improves functional and postural control in people with chronic ankle instability. In hop exercises, the athlete exercises 3 days a week for 6 weeks. The athlete runs 5 minutes in each session to warm up at the beginning of the training session, 5 minutes of dynamic stretching, and 5 minutes of cooling at the end .The exercises get harder every week, the level of reliance changes and the number of repetitions and sets increases, the person first has his hands free and then puts his hands on his chest and finally behind his head. There is a 30 second break between sets and a 1 minute break between workouts .The exercises are done in front of a mirror and the person has both visual and auditory feedback (the person is told about his mistakes and is motivated).Hop exercises include the following exercises (the exercises are randomly in the text below) . Forward hopping Hopping in 4-square shape Hopping side to side Hopping forward and back ward Hopping in zigzag shape Hopping in figure-8 shape
Category
Treatment - Other

2

Description
Intervention group: Agility Ladder: An agility ladder is an inexpensive and accessible device that is placed on the ground like a ladder and the person moves one or two feet in and out of it. Depending on the purpose, it can be made of different lengths and widths. It can also be made using a tape or rope. The person also maintains his or her balance while moving rapidly, which is used in various sports to improve performance, improve acceleration, speed, coordination, dynamic balance, static, and body posture. Two of its most important goals are to improve coordination and speed, and the agility ladder is the best way to teach movement patterns. For best results, the exercises should progress from easy to difficult. Also, in the type of exercises, the type of sports activity of the person should be considered. The second group receives agility ladder exercises that they do 3 times a week for 6 weeks. Before training, they run for 5 minutes and do 5 minutes of dynamic stretching and warm up. The training lasts for 10 minutes and at the end, they cool down for 5 minutes. The exercises become more difficult as the progress progresses and the number of sets and repetitions varies, with 30 seconds between repetitions and 1 minute rest between sets. The exercises are as follows: Lateral two in two out Two in the hole Two in lateral One lateral Lateral ickey shuffle ickey shuffle backward ickey shuffle frontal two in two out forward zigzag cross over shuffle zigzag cross over shuffle backward frontal two in two out backward
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation Sciences of Iran University of Medical Sciences
Full name of responsible person
Holakoo Mohsenifar
Street address
School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran St, Shah Nazari St, Madar Sq, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
mohsenifarpt@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
mohsenifarpt@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Holako Mohsenifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran St, Shah Nazari St, Madar Sq, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
1545913487
Email
Mohsenifarpt@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Holako Mohsenifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran St, Shah Nazari St, Madar Sq, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
Mohsenifarpt@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Holako Mohsenifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran St, Shah Nazari St, Madar Sq, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
Email
Mohsenifarpt@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
Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders
Under which criteria data/document could be used
The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of ankle sprain and chronic ankle instability.
From where data/document is obtainable
Applicants can contact the researcher of this study Elham Yazdani by email. Email address: elhamyazdani992@gmail.com
What processes are involved for a request to access data/document
Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days.
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