Objective: The aim of this study is to determine the effects of cooling, on knee extensor muscles strength and knee joint propriocetion (knee position sense) when applied over the quadriceps and over the knee joint, on the dominant leg .
Design: This is a randomized clinical trial study with control group. Setting: 40 healthy volunteer female students will be randomly assigned to an interventional group or to a control group. Inclusion and Exclusion: The main inclusion criteria are healthy young female volunteer students aged between 18 and 30 years old who refer to Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences. The main exclusion criteria are any neuromusculoskeletal and cardiopulmonary problems during intervention and some problems such as low back pain; tumors; migraine; vertigo; deep vein thrombosis, hip, knee and ankle joints deformities, pregnancy, any allergy to cooling and Raynaud's phenomenon . Intervention: The ice will be applied in the form of ice bag, filled with crushed ice, for 15 minutes over the quadriceps and knee joint. Main Outcome Measures: Immediately after, 30 minutes after and 1 hour post- cooling, knee extensor muscles strength and the intermediate range of knee flexion (from 40 ° and 60 ° ) will be used to assess proprioception ( joint position sense).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051422539N3
Registration date:2016-07-06, 1395/04/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-06, 1395/04/16
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
Vice chancellor for research,Semnan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cooling on knee extensor muscles strength and proprioception of knee joint in healthy young women
Public title
The effect of cooling on muscle strength and proprioception in healthy subjects
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Healthy young volunteer female students aged between 18 and 30 years old. Exclusion criteria: Any neuromuscular or musculoskeletal and cardiopulmonary problems during interventional sessions; some problems such as low back pain; tumors; migraine; vertigo; deep vein thrombosis; any lower limb joint deformity; pregnancy; lower limbs fracture during last year; any severe trauma in trunk or lower limbs during last 3 months; any allergy to cooling; Raynaud's phenomenon.
Age
From 18 years old to 30 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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, Kilometer 5 of Damghan Road, Semnan University of Medical Sciences
City
Semnan
Postal code
Approval date
2016-03-17, 1394/12/27
Ethics committee reference number
IR.SEMUMS.REC.1394.194
Health conditions studied
1
Description of health condition studied
Injury of lower limb
ICD-10 code
M99.-;6
ICD-10 code description
Injury of muscles and tendons of anterior muscle group at knee and thigh level
Primary outcomes
1
Description
Muscle strength
Timepoint
Before, immediately after, 30 and 60 minutes after intervention
Method of measurement
N/M By isokinetic dynamometer
2
Description
Intermediate range of knee flexion from 40 ° and 60 ° to assess proprioception (joint position sense)
Timepoint
Before, immediately after, 30 and 60 minutes after intervention
Method of measurement
In degree by isokinetic dynamometer
Secondary outcomes
empty
Intervention groups
1
Description
In the control group a bag without ice will be used over the knee and bulk of quadriceps for 15 minutes.
Category
Prevention
2
Description
The ice will be applied in the form of ice bag, filled with crushed ice, for 15 min over the quadriceps and knee joint. The temperature will be measured by the digital thermometer.
Category
Prevention
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
Mashahir Square, in front of Helal Ahmar, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidipour
Street address
Kilometer 5 of Damghan Road, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5 of Damghan Road, Rehabilitation faculty, Semnan University of Medical Sciences, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ziasafavi@yahoo.com
Web page address
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
Other areas of specialty/work
Street address
Kilometer 5 of Damghan Road, Rehabilitation faculty, Semnan University of Medical Sciences, Semnan
City
Semnan
Postal code
Phone
+98 233365480
Fax
Email
ziasafavi@yahoo.com
Web page address
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
Other areas of specialty/work
Street address
Kilometer 5 of Damghan Road, Rehabilitation faculty, Semnan University of Medical Sciences, Semnan
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ziasafavi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)