Protocol summary

Summary
Objective: The main purpose of the present study is to define effect of knee kinesiotaping on postural control in subjects with ACL deficiency especially in challenging postures. Design: Randomized control trial, single blinded. Setting and conduct: Patients will receive treatment with kinesiotaping or placebo. Major Inclusion criteria: Participants must be between ages 18-35؛ complete and non- complete tear of anterior cruciate ligament with and without meniscal injury. Major Exclusion criteria: Serious neurological disorders; musculoskeletal disorders (except for ACLD)؛ history of falling؛narcotic usage 48 hours before test؛usage of alcohol within 48 hours before test. Intervention: Kinesiotaping Main outcome measures (variables): Postural control that will be measured using center of pressure. The center of pressure will be calculated using force platform.

General information

Acronym
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IRCT registration information
IRCT registration number: IRCT2016122131506N1
Registration date: 2017-06-08, 1396/03/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-08, 1396/03/18
Registrant information
Name
Salman Nazary-Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6713
Email address
nazaryms@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of kinesiotaping on postural control in subjects with ACL deficiency: a randomized clinical trial
Public title
Effect of kinesiotaping on postural control in subjects with ACL deficiency: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Participants must be between ages 18-35؛ complete and non- complete tear of anterior cruciate ligament with and without meniscal injury. Exclusion criteria: ACLD (ACL deficient) subjects will be excluded if they had any serious neurological disorders؛ musculoskeletal disorders (except for ACLD)؛ history of falling؛ narcotic usage 48 hours before test؛ usage of alcohol 48 hours before test.
Age
From 18 years old to 35 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Online randomization

Secondary Ids

1

Registry name
----
Secondary trial Id
---
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Commitee of Mashhad University of Medical Sciences
Street address
Doctora Cross road, Beside hoveyzeh Cinema
City
Mashhad
Postal code
Approval date
2017-02-15, 1395/11/27
Ethics committee reference number
IR.MUMS.REC.1395.598

Health conditions studied

1

Description of health condition studied
Anterior Cruciate Ligament Tear
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee

Primary outcomes

1

Description
Postural Sway
Timepoint
Before intervention, Immediately after internention
Method of measurement
Force Platform Device

Secondary outcomes

1

Description
Disability
Timepoint
Before and two days after intervention
Method of measurement
Koos Questionnaire

Intervention groups

1

Description
Intervention group: A 5-cm-wide Kinesiotape (Ares, Korea) will be used in treatments. Few hours after shaving the area of the skin to be taped, Y-shaped tapes will be applied in origin-insertion direction to facilitate the muscles. While the patient is lying on lateral position, the tape will be placed on the rectus femoris muscle with a tension of 25–30% bringing the hip to extension and the knee to 30-35° of flexion and the tape will be placed on the hamstring muscle with a tension of 40–50% by bringing the hip to flexion and the knee to extension. A corrective kinesiotaping with a tension of 100% will be attached on anterior surface of tibia on 30 degrees of flexion and pull the tibia into backward in relation to the femur.
Category
Rehabilitation

2

Description
Control group: Placebo kinesiotape will be applied without tension on the front and back side of the knee.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital, Balance Laboratory
Full name of responsible person
Mr Javad Zarandi
Street address
Balance Laboratory, Physiotherapy Department, Ghaem Hospital, Mashhad, Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Doctora Cross road, Ghoreshi Building
City
Mashhad
Grant name
Grant code / Reference number
950879
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Salman Nazary-Moghadam
Position
Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini 93, Number 89
City
Mashhad
Postal code
Phone
00
Fax
Email
nazary_salman@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Salman Nazary-Moghadam
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Paramedical Sciences
City
Mashhad
Postal code
Phone
00
Fax
Email
nazary_salman@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Salman Nazary-Moghadam
Position
Assistant Professor of Physiotherapy
Other areas of specialty/work
Street address
Faculty of Paramedical Sciences, Vakilabad Blvd, Bahonar Blvd, Pardis Campus, Mashhad, Iran
City
Mashhad
Postal code
Phone
00
Fax
Email
nazary_salman@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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