Immediate effects of Kinesio Taping on pain, joint effusion, Knee Range of Motion, and quadriceps muscle activity in Acute phase Anterior Cruciate Ligament reconstruction
assess of Immediate effects of Kinesio Taping on pain, joint effusion, knee Range of Motion, and quadriceps muscle activity in Acute Phase Anterior Cruciate Ligament reconstruction
Design
The study is single blind clinical trial type
Settings and conduct
This study will be conducted on volunteer patients with ACL reconstruction by hamstring graft in first tow weeks after surgery, in Zahedan, Razmjoo moghaddam physiotherapy clinic of university of medical sciences. Patients will be entered randomly to one of the routine or kinesio taping groups. The patients will only be informed of their group
Participants/Inclusion and exclusion criteria
patient with unilateral ACL reconstruction with hamstring tendon graft, this subjects have no previous history of FX, DX & structural malformation in lower limbs
Intervention groups
group of routine physiotherapy treatment which include using from bracing, CPM, electrical stimulation, quad set & ankle pump & knee extension exercise (close kinematic chain in 0-60 degree & open kinematic chain in 40-90 degree). other group which received kinesio taping in addition to routine physiotherapy & called kinesio tape group
Main outcome variables
level of quadriceps electrical activity in electromyography level, free passive range of motion of knee, pain & swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040466N3
Registration date:2020-12-28, 1399/10/08
Registration timing:retrospective
Last update:2020-12-28, 1399/10/08
Update count:0
Registration date
2020-12-28, 1399/10/08
Registrant information
Name
Fateme Ghiasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 6708
Email address
f_ghiasi_p@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immediate effects of Kinesio Taping on pain, joint effusion, Knee Range of Motion, and quadriceps muscle activity in Acute phase Anterior Cruciate Ligament reconstruction
Public title
Immediate effects of Kinesio Taping on pain, joint effusion, Knee Range of Motion, and quadriceps muscle activity in Acute phase Anterior Cruciate Ligament reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
years: range: 18_45, males @ females
unilateral ACL reconstruction with hamstring tendon graft without meniscus repair
patients should refer in 2 weeks after ACL reconstruction
no previous history of lower limbs Fracture, dislocation or structural malformation
Exclusion criteria:
bilateral ACL reconstruction with hamstring tendon graft
ACL reconstruction with bone patellar tendon bone graft
patients refer after 2 weeks from sergury
history of fracture, dislocation & structural malformation in lower limbs
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected by available sampling method. then by randomization permutation blocks method will enter the two groups: A: routine treatment group B: kinesiotaping group. In this method, after determining the age and sex, patients will enter the research in the following order: BBAAABABBAABABABBAABAABABBBAAB
In this method, for example patient number 1 will enter group B and patient number 3 will enter group A and so on it will continue.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are considered blind regardless of the difference in treatment methods of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hesabi street, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-07-31, 1398/05/09
Ethics committee reference number
IR.ZAUMS.REC.1398.175
Health conditions studied
1
Description of health condition studied
ACL reconstruction
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
level of quadriceps electrical activity in electromyography level
Timepoint
first day & forth day
Method of measurement
in this study use from surface electromyography (Bio Graph infiniti, 2180 Belgrave Avenue, Montreal, QC H4A 2L8 Canada )
Intervention group: kinesiotaping group, in this group use from kinesiotaping application addition to routine physiotherapy program after acl reconstruction
Category
Treatment - Devices
2
Description
Intervention group: routine physiotherapy group
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
RAZMJOU MOGHADDAM physiotherapy clinic
Full name of responsible person
ashkan azarkish
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo Moghadam Laboratory, Ayatoallah Kafami St.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9813664855
Phone
+98 54 3342 4675
Email
ashkanazarkish@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr hoseynifar
Street address
Zahedan University of Medical Sciences,Dr.Hesabi sq
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
public@zaums.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Ghiasi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Ghiasi
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Ghiasi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khatam al anbia Hosp, Jame jam Blvd
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
f_ghiasi_p@zaums.ac.ir
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