Comparison of the effect of a course of combined training with and without visual feedback on plantar pressure, proprioception, kinematics and joint functional instability in people with chronic Ankle sprains.
Is there a difference between the effect of a combined training course with and without visual feedback on plantar pressure parameters, joint kinematics, proprioception and functional instability in people with chronic ankle sprains?
Design
A controlled, parallel-group, single-blind, randomized, supportive clinical trial on 66 patients. Simple randomization was used for randomization.
Settings and conduct
This research will be done inside Kharazmi University and the participants will be blinded and it will be done in the form of pre-test and post-test.
Participants/Inclusion and exclusion criteria
Inclusion criteria from the research:
1. People aged between 20-30 years old with a history of chronic ankle sprains
2. A score less than 27 in the Cumberland Questionnaire
3. History of weakness and instability in the ankle at least in the last 3 months
4. Confirmation by a specialist doctor
Exclusion criteria from the research:
1. Absence of maximum 3 sessions in exercises
2. Wrist or knee injuries during the research process
3. Having abnormalities that affect the research process
4. Participation in rehabilitation programs in the last 6 months
Intervention groups
The research has 2 intervention groups and 1 control group.
1- Group of combined exercises.
2- Group of combined exercises with visual feedback.
3- Control group.
Comparison of the effect of a course of combined training with and without visual feedback on plantar pressure, proprioception, kinematics and joint functional instability in people with chronic Ankle sprains.
Public title
Comparison of the effect of a course of combined training with and without visual feedback on plantar pressure, proprioception, kinematics and joint functional instability in people with chronic Ankle sprains.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men aged between 20-30 years with a history of chronic ankle sprains
Scored less than 27 on the Cumberland Questionnaire
History of weakness and instability in the ankle, at least in the last 3 months
Confirmation by a specialist physician
Exclusion criteria:
Injury to the ankle or knee during the research process
Having abnormalities in the ankle or knee that affect the research process.
Participation in rehabilitation programs in the last 6 months
People with mental and physical disabilities
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
This research has done randomization through the statistical method of simple randomization using block method. This research will be assigned to 2 intervention groups and 1 control group with the help of the web program (randomizer.org). A member of the research team, who will not be involved in this part, is asked to perform the random allocation sequence of the samples using a computer program. Randomly sequenced sealed envelopes will be used in order to conceal the allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person who is responsible for analyzing the data is unaware of the individuals and groups and only analyzes the results and statistical data taken in the two tests.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Sports Science Research Institute
Street address
No. 3, Fifth Alley, Mir Emad St, Ostad Motahari St
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-11-21, 1402/08/30
Ethics committee reference number
IR.SSRC.REC.1402.255
Health conditions studied
1
Description of health condition studied
Ankle sprain
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle
Primary outcomes
1
Description
foot pressure.
Timepoint
The beginning of the study and the end of the study
Method of measurement
Force plate device.
2
Description
proprioception
Timepoint
The beginning of the study and the end of the study
Method of measurement
Isokinetic device.
3
Description
Kinematic
Timepoint
The beginning of the study and the end of the study
Method of measurement
Motion Analysis device.
4
Description
Functional instability
Timepoint
The beginning of the study and the end of the study
Method of measurement
Cumberland Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The combined exercises of these exercises include exercises with resistance band and wobble board for 8 weeks, resistance band exercises are performed from 1 to 3 sets in different colors of red, green, blue and black, which have different resistance. Wobble board exercises will be done in 3 sets at a height of 1 inch in the first weeks and in 5 sets at a height of 3 inches.
Category
Rehabilitation
2
Description
Intervention group: combined exercises with visual feedback, these exercises include exercises with resistance band and wobble board for 8 weeks, resistance band exercises are performed from 1 to 3 sets in different colors of red, green, blue and black, which have different resistance. . Wobble board exercises will be done in 3 sets at a height of 1 inch in the first weeks and in 5 sets at a height of 3 inches. The drill is a visual feedback that is created by a reaction treadmill and a monitor. This protocol can be done at a speed of 4 km/h on a treadmill and for 6 minutes in the first weeks and up to 20 minutes in the last weeks.
Category
Rehabilitation
3
Description
Control group: This group does not receive training or intervention during the study period.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kharazmi University, Karaj branch
Full name of responsible person
Alireza Abbasi
Street address
Kharazmi University, University Square, Shahid Beheshti Street
City
Karaj
Province
Alborz
Postal code
3197937551
Phone
+98 26 3457 9600
Email
info@khu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Kharazmi university
Full name of responsible person
Mohammad Delnavaz
Street address
Kharazmi University, University Square, Shahid Beheshti Street
City
Karaj
Province
Alborz
Postal code
3197937551
Phone
+98 26 3457 9600
Email
info@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Not applicable
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
The personal data of people is a personal matter and if people give their permission, this data will be published, and if people do not give permission to publish this data, it will remain confidential.
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
Academic researchers and those who are engaged in research in this field.
Under which criteria data/document could be used
The data of this research is available to researchers for all review and meta-analysis researches.
From where data/document is obtainable
To the email address: abbasialireza155@gmail.com
What processes are involved for a request to access data/document
The applicant will receive the data after 10 to 15 days after sending an email to the said address.