Fitness and running are one of the main activities of people. Anterior cruciate ligament rupture usually occurs during rotational and shear movements. The use of sand in short-term treatment programs can be beneficial, but no studies have been conducted on long-term exercise on sand. Therefore, the aim of this study was to investigate the effect of exercises on sand on the mechanics of walking and running in people with anterior cruciate ligament injury with flat feet.
Design
Clinical trial with control group, with parallel, randomized, pre-test and post-test groups on 15 patients and 15 healthy individuals. Excel software rand function was used for randomization.
Settings and conduct
Testing will be done in a biomechanics laboratory with dimensions of 10 x 6 meters. Subjects are tested after preparation using EMG devices and pre-force plate. Then both groups of subjects will be trained on sand for 8 weeks and will be tested again.
Participants/Inclusion and exclusion criteria
Inclusion criteria for people with ACL and peronite foot injury
Exclusion criteria: History of lower extremity surgery over the past 5 years, spinal abnormalities, osteoporosis, fractures or gait disorders
Intervention groups
The experimental group of people with anterior cruciate ligament injury with ACL rupture will be trained on sand for 8 weeks. The effectiveness of this training course is evaluated using pre-test and post-test. Exercise may be helpful in improving and reducing the subjects' pain. The above exercises have no side effects.
Main outcome variables
The peak of the earth's reaction force; Time to reach the peak of the earth's reaction force; Free torque of the earth's reaction force; Frequency spectrum of muscle electrical activity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200912048696N1
Registration date:2021-03-14, 1399/12/24
Registration timing:prospective
Last update:2021-03-14, 1399/12/24
Update count:0
Registration date
2021-03-14, 1399/12/24
Registrant information
Name
hamed sheikhalizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 4343 2602
Email address
hamed.sh2102@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of training on sand on walking and running mechanics in people with anterior cruciate ligament injury
Public title
Investigating the effect of training on sand on walking and running mechanics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with peronitis injuries and feet
Exclusion criteria:
History of lower extremity surgery over the past 5 years
Spinal abnormalities, osteoporosis, fractures or gait disorders
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this type of sampling, each member of the defined community has an equal and independent chance to be included in the sample. Being independent means that the election of a member has no effect on the election of other members of society. In this sampling, the chances of representing the sample and the community without special bias and population increase increase.
In this method, first the list of names of all members is obtained, then a score or number is assigned to each of them and the required number is selected using a table of random numbers.
Because the study population is small, the lottery method is used, ie the names of the people are written on a piece of paper and placed inside the box, then the papers are taken out one by one until the desired sample size is complete.
Blinding (investigator's opinion)
Single blinded
Blinding description
The research has two groups, A group as control group. Subjects (test participants) will not be aware of the existence of two groups. Only the steps of taking the test will be explained to him.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Baqiyatallah Al-Azam Hospital
Street address
Mulla Sadra St., South Sheikh Baha'i St.
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2021-02-08, 1399/11/20
Ethics committee reference number
IR.BMSU.BAQ.REQ.1399.050
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament injury
ICD-10 code
S83
ICD-10 code description
Dislocation and sprain of joints and ligaments of knee
Primary outcomes
1
Description
Walking and running mechanics
Timepoint
Pre-test will be done and after 8 weeks of post-test practice
Method of measurement
Bertec force plate - electromyography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People with anterior cruciate ligament injury with a flat foot are trained on the sand for 8 weeks
Category
Treatment - Other
2
Description
Control group: In the control group, people with anterior cruciate ligament injury with peronite foot only participate in pre-test and post-test. Only routine treatment is performed and no new intervention will be performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohaghegh Ardabili University Health and Wellness Center
Full name of responsible person
AmirAli Jafarnezhadgero
Street address
Mohaghegh Ardabili University, University Street
City
Ardebil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3352 0457
Email
behrooz.h@gmil.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
alireza shahriyari
Street address
Mulla Sadra St., South Sheikh Baha'i St
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8860 0030
Email
hamed.sh2102@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
alireza shahriyari
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Majid Mafi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanic
Street address
Mulla Sadra St., South Sheikh Baha'i St
City
tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8860 0030
Email
hamed.sh2102@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Majid Mafi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanic
Street address
Mulla Sadra St., South Sheikh Baha'i St
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8860 0030
Email
hamed.sh2102@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Majid Mafi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanic
Street address
Mulla Sadra St., South Sheikh Baha'i St
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8860 0030
Email
hamed.sh2102@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
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
The collected data will be made available to the public in the form of articles and dissertations after analysis.
When the data will become available and for how long
Access period 2 months after printing the results
To whom data/document is available
Instructor and the test taker
Under which criteria data/document could be used
Article and dissertation
From where data/document is obtainable
Supervisor
What processes are involved for a request to access data/document