Effects of prophylactic ankle supports on balance, perceived stability and ground reaction force during lateral landing before and after fatigue in healthy female college sport student
Aim to evaluate the effect of prophylactic ankle support on time to stabilization, perceived stability and peak vertical ground reaction force in subjects without a history of ankle injuries before and after fatigue.
Design
Clinical trial in one group, not randomized, not blinded
Settings and conduct
All tests were performed at the sport rehabilitation lab at Bu-Ali Sina University. Twenty-seven healthy female collegiate ethletes participated in the present study in one group. The lateral landing was carried out from a step with a height of 30 cm before and after the fatigue protocol. The test conditions (normal and with tape and brace) were selected randomly and by drawing.
Participants/Inclusion and exclusion criteria
The participants were healthy with no history of ankle or knee injury in the past 12 months; no history of surgery or fractures of the lower extremities and no apparent deformities such as flat foot or high arch.
Intervention groups
The present study was performed on a group before and after induced fatigue. Fatigue protocol, kinesiotape and ankle brace were used as intervention in this study.
Main outcome variables
Time to stabilization; perceived stability and ground reaction were measured pre and post fatigue.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046368N2
Registration date:2020-03-31, 1399/01/12
Registration timing:retrospective
Last update:2020-03-31, 1399/01/12
Update count:0
Registration date
2020-03-31, 1399/01/12
Registrant information
Name
Zahra Raeisi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3492
Email address
z_raisi13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-03, 1398/01/14
Expected recruitment end date
2019-04-09, 1398/01/20
Actual recruitment start date
2019-04-03, 1398/01/14
Actual recruitment end date
2019-04-09, 1398/01/20
Trial completion date
2019-04-10, 1398/01/21
Scientific title
Effects of prophylactic ankle supports on balance, perceived stability and ground reaction force during lateral landing before and after fatigue in healthy female college sport student
Public title
Prophylactic ankle support and performance in female college sport student
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No history of ankle or knee injury in the past 12 months
No history of surgery in the lower extremities
No history of fractures in the lower extremities
No apparent deformities in the leg such as flat foot or high arch
Exclusion criteria:
Chronic diseases such as patellofemoral pain syndrome in lower extremity
Any problems affecting postural control and balance
Age
From 18 years old to 26 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
27
Actual sample size reached:
27
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Science, in front of People's Garden, Shahid Fahmideh Street
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2019-02-10, 1397/11/21
Ethics committee reference number
IR.UMSHA.REC.1397.762
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Time to stabilization
Timepoint
Pre and Post Fatigue
Method of measurement
Plantar pressure platform
2
Description
Perceived stability
Timepoint
Pre and postfatigue
Method of measurement
Questionnaire
3
Description
Ground reaction force
Timepoint
Before and after fatigue
Method of measurement
Plantar pressure platform
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bruce fatigue protocol was used for exerting fatigue. The subjects ran on a treadmill until exhaustion while increasing speed and incline.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-ali Sina university
Full name of responsible person
Ali Yalfani
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517833131
Phone
+98 81 3838 1422
Email
Ali_yalfani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu Ali-Sina University
Full name of responsible person
Gholamhossein Majzoubi
Street address
Vice Chancellery For Research Affairs, Bu Ali Sina University, Chahar Bagh Martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517833131
Phone
+98 81 3838 1601
Email
sakhai@basu.ac.ir
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
Ali Yalfani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1422
Email
ali_yalfani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali-Sina University
Full name of responsible person
Ali Yalfani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1422
Email
ali_yalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@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
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
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data on the time to stabilization and vertical ground reaction force can be shared.
When the data will become available and for how long
Starting access after publishing study results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Some of the information obtained after the analysis will be possible only for specialists in this field.
From where data/document is obtainable
Ali Yalfani آدرس ایمیل: Ali_yalfani@yahoo.com
What processes are involved for a request to access data/document
Information will be available one year after publication.