Protocol summary

Study aim
The aim of this study is to evaluate effects of ankle joint taping on force plate system kinetic changes and lower limb functional activity in athletes with chronic ankle sprain in perturbation condition
Design
30 athletes with chronic ankle sprain participate in this study and single blinded randomly assigned to two intervention and control groups with block stratified randomization using windows software.
Settings and conduct
The volunteer athletes with chronic ankle sprain referred to Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences, participate in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria for this study are full consent for participating; 20-35 years old; have regular training sessions 3 days a week and from 6 months before the study at least; have at least one giving way after the first lateral ankle sprain; lower than 4 visual analogue scale score. Exclusion criteria are musculoskeletal deficit like bow leg, knock knee, flat foot or pes cavus; direct trauma to ankle or surgery; both ankles lateral sprain; pregnancy; body mass index equal or more than 30 kilograms per square meter; pathology in ankle such as cellulitis, cutting, ekimoz or osteomyelitis; rheumatic disease like rheumatoid arthritis.
Intervention groups
In the intervention group taping will be applied on ankle periarticular bones for mechanical correction with 20%, 70% and 100% tensions in 3 sessions during 9 days. In the control group taping without tension will be applied on ankle periarticular bones exactly like the intervention group in 3 sessions during 9 days.
Main outcome variables
Vertical jump measure, power, peak velocity, time to reach maximum force and ground reaction force will be assessed in both groups before and after 9 days intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150602022539N10
Registration date: 2020-08-22, 1399/06/01
Registration timing: prospective

Last update: 2020-08-22, 1399/06/01
Update count: 0
Registration date
2020-08-22, 1399/06/01
Registrant information
Name
Ziaeddin Safavi Farokhi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
zsafavi@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of ankle joint taping on force plate system kinetic changes and lower limb functional activity in athletes with chronic ankle sprain in perturbation condition
Public title
Effects of ankle joint taping on force plate system kinetic changes and lower limb functional activity in athletes with chronic ankle sprain in perturbation condition
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participation with willingness Age between 20 and 35 Have training sessions constantly 3 days a week and from 6 month past at least Have at least one giving way after the first time lateral ankle sprain less than 4 visual analogue scale score
Exclusion criteria:
Musculoskeletal deficit like bow leg, knock knee, flat foot or pes cavus Direct trauma to ankle or surgery Both ankles lateral sprain Pregnancy Body mass index equal or more than 30 kg/m2 Pathology in ankle such as cellulitis, cutting, ekimoz or osteomyelitis Rheumatic disease like rheumatoid arthritis
Age
From 20 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study the participants and statistical analyzer will be blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Kilometer 5 Damghan road, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.SEMUMS.REC.1399.153

Health conditions studied

1

Description of health condition studied
Chronic ankle sprain
ICD-10 code
S93
ICD-10 code description
Dislocation and sprain of joints and ligaments at ankle, foot and toe level

Primary outcomes

1

Description
Vertical jump measure
Timepoint
Before and after 9 days intervention
Method of measurement
Motion analysis system

2

Description
Power
Timepoint
Before and after 9 days intervention
Method of measurement
Force plate system

3

Description
Peak velocity
Timepoint
Before and after 9 days intervention
Method of measurement
Force plate system

4

Description
Time to reach maximum force
Timepoint
Before and after 9 days intervention
Method of measurement
Force plate system

5

Description
Ground reaction force
Timepoint
Before and after 9 days intervention
Method of measurement
Force plate system

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 100, 70 and 20 percent tension taping on ankle bones in 3 sessions during 9 days
Category
Rehabilitation

2

Description
Control group: taping without tension on ankle bones in 3 sessions during 9 days
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular rehabilitation research center of Semnan university of medical sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Street address
In front of Helal Ahmar, Mashahir square, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kuhkhaii
Street address
in front of Helal Ahmar, Mashahir Square, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
p-kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences,5th Kilometers to Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, 5 Kilometers to Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
ziasafavi@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
Not applicable
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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