To determine the effect of eight weeks of corrective intervention on lower extremity muscle electrical activity in women with limited ankle dorsiflexion
Design
A clinical trial with a control group, parallel groups, single-blinded, randomized
Settings and conduct
Athletes with limited ankle dorsiflexion will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups based on allocation concealment using the SNOSE method. This study will be conducted in a single-blind way so that the outcome assessors will not know about the allocation of the study groups and the reason for their presence in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: talocrural dorsiflexion range of motion less than 17 degrees with the knee extension, having at least three years of regular sports experience, and having a normal BMI (20-25). Exclusion criteria: functional and mechanical instability of the ankle joint, history of ankle sprain in the last year, history of fracture or surgery in the lower extremity and having postural abnormalities, and history of ligament or meniscus injury in the knee.
Intervention groups
The intervention group will receive rehabilitation exercises that include fascia release and triceps surae muscle, stretching and strength of shin muscle, and talocrural joint mobilization for 8 weeks and 3 sessions of 1 hour each week. To perform exercises, equipment such as straps, and tools that help the mobility of soft tissue will be used. Control group: no intervention.
Main outcome variables
Electromyographic activity of ankle muscle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190224042827N4
Registration date:2022-11-05, 1401/08/14
Registration timing:retrospective
Last update:2022-11-05, 1401/08/14
Update count:0
Registration date
2022-11-05, 1401/08/14
Registrant information
Name
Farzane Ramezani
Name of organization / entity
Bu Ali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1423
Email address
f.ramezani@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-12, 1401/07/20
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of corrective intervention on lower extremity muscle electrical activity in women with limited ankle dorsiflexion
Public title
Effect of rehabilitation program exercises on limited ankle dorsiflexion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having ankle dorsiflexion range of motion less than 17 degrees
Having at least three years of regular sports experience
Having a normal BMI (20-25)
Exclusion criteria:
Functional and mechanical instability of the ankle joint
History of ankle sprain in the last year
History of fracture or surgery in the lower extremity and having postural abnormalities
History of ligament or meniscus injury in the knee
Age
From 15 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on the Random Number Generator software and uses the SNOSE method to assign double groups based on the allocation concealment. The randomization of subjects was done in two stages. First, each of the subjects chooses a number between 1-30 using a lottery, then fifteen random numbers are selected between the numbers 1-30 using the Random number generator software, and according to the generated numbers, the chosen numbers of subjects are divided into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessors (laboratory technicians) are asked to take the desired tests from the clients. They will be unaware of the purpose of the research, the allocation of study groups, and the reason for the clients' presence in the laboratory, and they will only evaluate the variables and record their observations.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bu Ali Sina University
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Approval date
2021-10-13, 1400/07/21
Ethics committee reference number
IR.BASU.REC.1400.042
Health conditions studied
1
Description of health condition studied
Ankle injury
ICD-10 code
S99.9
ICD-10 code description
Unspecified injury of ankle and foot
Primary outcomes
1
Description
Electromyographic activity of ankle muscle
Timepoint
Before the intervention begins, One day after the end of the intervention
Method of measurement
Electromyographic device
Secondary outcomes
1
Description
Impairment of muscle activity
Timepoint
Before and after intervention
Method of measurement
Surface Electromyography Device Model Data Log p3 X8
Intervention groups
1
Description
Intervention group: rehabilitation program exercise, exercises will be 3 sessions of 1 hour per week for 8 weeks, and equipment will be used for exercises such as a strap, instrument assisted soft tissue mobilization. The rehabilitation exercise protocol of the study includes a release of facia and triceps surae muscle, stretching and strength of shin muscle, and talocrural joint mobilization.
Category
Rehabilitation
2
Description
Control group: No intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Committee of sport of Bu-Ali Sina University
Full name of responsible person
Tahereh Sohrabi
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
haniesohrabi1614@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Dr Arash Ghorbani Choghamarani
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 382702070
Email
a.ghorbani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Ali Sina 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
Bu Ali Sina University
Full name of responsible person
Tahereh Sohrabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Fax
Email
haniesohrabi1614@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Tahereh Sohrabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Fax
Email
haniesohrabi1614@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Farzane Ramezani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Fax
Email
f.ramezani@phe.basu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available