Protocol summary

Study aim
The main purpose of the present work is to examine the effect kinesiotaping on postural control in patients who underwent ACL reconstruction during challenging conditions.
Design
Pragmatic, community based, parallel group, single blind, randomized controlled trial
Settings and conduct
In the present study, a series of 40 numbers including "1" and "2" will be determined. These will then be placed in a sealed envelope. The numbers will be selected from top to down by the physiotherapy ward secretary, respectively. Single blinded The participant, assessor, and statistical analyzer will be blinded from the allocation details.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants aged between 18 and 35 years, In addition, It was included all complete and non- complete tear of anterior cruciate ligament with and without meniscal injury in the present study. Exclusion criteria subjects will be excluded if they had any serious neurological disorders, musculoskeletal disorders (except for ACLD), history of falling؛ narcotic usage 48 hours before data collection, alcohol usage 48 hours before data collection.
Intervention groups
Intervention group: 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. Control group: Placebo kinesiotape will be applied without tension on the front and back side of the knee.
Main outcome variables
Postural sway

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161221031506N4
Registration date: 2020-08-11, 1399/05/21
Registration timing: prospective

Last update: 2020-08-11, 1399/05/21
Update count: 0
Registration date
2020-08-11, 1399/05/21
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
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of kinesiotaping on postural control in participants with ACL reconstruction: a randomized clinical trial
Public title
Effect of kinesiotaping on balance in participants with ACL reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Participants aged between 18 and 35 years, In addition, It was included all complete and non- complete tear of anterior cruciate ligament with and without meniscal injury in the present study.
Exclusion criteria:
Exclusion criteria subjects will be excluded if they had any serious neurological disorders, musculoskeletal disorders (except for ACLD), history of falling؛ narcotic usage 48 hours before data collection, alcohol usage 48 hours before data collection.
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using sealed envelopes. In the present study, a series of 40 numbers including "1" and "2" will be determined using www.randomization.com. These will then be placed in a sealed envelope. The numbers will be selected from top to down by the physiotherapy ward secretary, respectively .
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinded. In the present work, placebo kinesiotaping will be used. Therefore, all the participants are unaware of which group they are in.
Placebo
Used
Assignment
Parallel
Other design features
En Online randomization

Secondary Ids

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
Province
Razavi Khorasan
Postal code
9191111111
Approval date
2020-02-08, 1398/11/19
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 of cruciate ligament of knee

Primary outcomes

1

Description
Postural Sway
Timepoint
Before intervention, Immediately after internention, 48 hours after intervention
Method of measurement
Force Platform Device

Secondary outcomes

1

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

2

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.
Timepoint
Before and two days after intervention
Method of measurement
IKDC

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
Placebo

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
Province
Razavi Khorasan
Postal code
9199171111
Phone
+98 51 3878 5445
Email
zarandimj1@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice chancellor for research, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9199171111
Phone
+98 51 3878 5445
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
950879
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mashhad University of Medical Sciences
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Emam Khomeini 93, Number 89
City
Mashhad
Province
Razavi Khorasan
Postal code
9199171111
Phone
+98 51 3878 5445
Email
nazaryms@mums.ac.ir

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
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Paramedical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9199171111
Phone
+98 87 85445
Email
nazaryms@mums.ac.ir

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
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Paramedical Sciences, Vakilabad Blvd, Bahonar Blvd, Pardis Campus, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9199171111
Phone
+98 915 301 0870
Email
nazary_salman@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The effect of kinesiotaping on postural control and functional disability at challenging conditions in patiens with ACL reconstruction
When the data will become available and for how long
2022-2023
To whom data/document is available
Salman Nazary-Moghadam
Under which criteria data/document could be used
Salman Nazary-Moghadam
From where data/document is obtainable
Nazary_salman@yahoo.com
What processes are involved for a request to access data/document
The effect of kinesiotaping on ACL reconstruction
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