The effects of Ankle Support on Ankle Kinematics in people with Ankle Sprain
Design
This is a Quasi-Experimental Study with Prospective directions.
The Sample included 10 Healthy Individuals and 10 Individuals with Chronic Ankle Sprains
Settings and conduct
Given the type of study, the first stage of this study is Cross Sectional. So that the Kinematic of the Ankle and Rearfoot in both groups of Healthy and Chronic Ankle Sprains will be recorded and then compared. in the second phase of this study, the effects of the strapping (With 5 random modes) on the Kinematic of the Ankle and Rearfoot in Healthy subjects and then in those with Chronic Ankle Sprains will be examined.
This RCT will be performed at the Muscloskeletal Research Center at Isfahan University of Medical Science.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:The existence of Mechanical Instability, Frequent ََAnkle Sprain at least 2 times in the last 12 months
Exclusion Criteria:Initial Ankle Sprain and Ankle giving a way during the last 6 weeks, history of Fracture or Ankle Surgery, Lower Extremity pain
Intervention groups
This study investigates the effect of one intervention (how to fasten the Neoprene Ankle Support Straps) on Ankle kinematics and Rearfoot in healthy individuals and then in individuals with chronic ankle sprain. The method of this study is before-afte.5 conditions including no strap and 3 types of straping will be investigated in a randomised order.the same intervention with the same method will be conducted in a group of individuals with chronic ankle sprain to undrestand the common effect of impairment and intervention together.
Main outcome variables
The Range of Motion of the Ankle and Rearfoot in 3 Planes of Motion, the maximum Range of Motion of the Ankle and Rearfoot.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200315046780N1
Registration date:2020-07-16, 1399/04/26
Registration timing:retrospective
Last update:2020-07-16, 1399/04/26
Update count:0
Registration date
2020-07-16, 1399/04/26
Registrant information
Name
Elham Ranjbar sepoleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3434 0190
Email address
inspiration_r11@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-08, 1398/09/17
Expected recruitment end date
2020-03-02, 1398/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Neoprene Ankle Support with figure 8 Straps on Rearfoot and Ankle Kinematic in people with Chronic Ankle Sprain
Public title
The Effect of Ankle Support on walking pattern in people with frequent Ankle Sprain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A History of at least one Ankle Sprain in the past three months that has resulted in Pain, Swelling, Stiffness and prevent People from participating in Sports, Recreation or other Activities for at least three weeks
The existence of Mechanical Instability
Frequent ََAnkle Sprain at least 2 times in the last 12 months
Low to medium Ankle Sprain
Chronic Unilateral Ankle Sprain and no injury to the opposite side
There are at least 5 reports of Ankle giving a way and tendency to Ankle giving a way during Exercise.
Exclusion criteria:
Initial Ankle Sprain and Ankle giving a way during the last 6 weeks
History of Fracture or Ankle Surgery, Lower Extremity pain not related to Ankle Sprain
Extreme Ankle Sprain
Pain in the lower Limb that is not related to Ankle Sprain
Balance problems, other Orthopedic diseases, Systemic and Neurological diseases such as Diabetes, MS, Stroke and Cerebral Palsy
Recent participation in a Rehabilitation program over the past month
History of using Neoprene Ankle Support over the past month
Over 90% score in Foot and Ankle Disability Index questionnaire
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study investigates the effect of one intervention (how to fasten the Neoprene Ankle Support straps) on ankle kinematics and rearfoot in healthy individuals and then in individuals with chronic ankle sprain. The method of this study is before-afte.4 conditions including no strap and 3 types of straping will be investigated in a randomised order.the same intervention with the same method will be conducted in a group of individuals with chronic ankle sprain to undrestand the common effect of impairment and intervention together.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Science, Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
81745164
Approval date
2019-11-08, 1398/08/17
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.433
Health conditions studied
1
Description of health condition studied
Chronic Ankle Sprain
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle
Primary outcomes
1
Description
Rearfoot and Ankle Kinematic
Timepoint
Measurement of the Ankle and Rearfoot Kinematic at the beginning of the study (without Intervention or without the use of Neoprene Ankle Support) with 7 repetitions and then the Kinematic of Ankle and Rearfoot measured with using the Neoprene Ankle Support.
Method of measurement
Using QTM software, inematic data is recorded, then we use Visual-3D software for kinematic analysis and data modeling and then statistical analysis is performed with SPSS software.
Secondary outcomes
empty
Intervention groups
1
Description
This study investigates the effect of one intervention (how to fasten the Neoprene Ankle Support straps) on ankle kinematics and rearfoot in healthy individuals and then in individuals with chronic ankle sprain. The method of this study is before-afte.4 conditions including no strap and 3 types of straping (using Neoprene Ankle Support with equal force of straps, using Neoprene Ankle Support with Evertor force of straps and using Neoprene Ankle Support with Invertor force of straps) will be investigated in a randomised order.the same intervention with the same method will be conducted in a group of individuals with chronic ankle sprain to undrestand the common effect of impairment and intervention together.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Science, School of Rehabilitation Science, Muscloskeletal Research Cen
Full name of responsible person
Elham Ranjbar Sehpole
Street address
Muscloskeletal Research Center, School of Rehabilitation Science, western door of the Esfahan University of Medical Science, Sofe Blvd
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3792 5229
Fax
+98 31 3668 7270
Email
muigaitlab@gmail.com
Web page address
https://msrcenter.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
dr.Shaghayegh Haghjoy Javanmard
Street address
Vice-Chancellery for Research and Technology, number 4 Bldg, Esfahan University of Medical Science, Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellery for Research and Technology of Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Elham Ranjbar Sehpole
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Orthosis and Prosthesis
Street address
in front of Motamed Clinic, Sartip Cross, Taleghani Ave
City
Esfahan
Province
Isfehan
Postal code
8136835133
Phone
+98 31 3434 0190
Email
inspiration_r11@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Ranjbar Sehpole
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Orthosis and Prosthesis
Street address
in front of Motamed Clinic, Sartip Cross, Taleghani Ave
City
Esfahan
Province
Isfehan
Postal code
8136835133
Phone
+98 31 3434 0190
Email
inspiration_r11@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Ranjbar Sehpole
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Orthosis and Prosthesis
Street address
in front of Motamed Clinic, Sartip Cross, Taleghani Ave
City
Esfahan
Province
Isfehan
Postal code
8136835133
Phone
+98 31 3434 0190
Email
inspiration_r11@yahoo.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
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