Protocol summary

Study aim
The effect of one session stimulating massage of knee flexor and extensor muscles on knee joint position sense in elderly
Design
Clinical trial with control group, Blinded, Randomized by choosing odd or even number, 20 subjects
Settings and conduct
The study is done at laboratory of Beheshty university
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men The range of 65 to 80 years Independent in walking Exclusion criteria: Open wound and VAS>3 in lower limb
Intervention groups
10 minutes massage will be used as an intervention in intervention group
Main outcome variables
Absolute error and Relative error and Variable error

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180721040536N1
Registration date: 2018-08-21, 1397/05/30
Registration timing: registered_while_recruiting

Last update: 2018-08-21, 1397/05/30
Update count: 0
Registration date
2018-08-21, 1397/05/30
Registrant information
Name
Mahmoud Akramzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5592 9986
Email address
mahmoudakramzade@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-05, 1396/05/14
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2017-08-19, 1396/05/28
Actual recruitment end date
2018-12-10, 1397/09/19
Trial completion date
empty
Scientific title
The Effect of Stimulating Massage of Knee Flexor and Extensor Muscles on Knee Joint Position Sense in Elderly
Public title
The Effect of Stimulating Massage of Knee Flexor and Extensor Muscles on Knee Joint Position Sense in Elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men Age range of 65-80 years Independent in walking
Exclusion criteria:
Open wound VAS>3 in lower limb Fracture or surgery in lower limb
Age
From 65 years old to 80 years old
Gender
Male
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 20
Actual sample size reached: 20
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were devided in 2 groups by random by picking up odd or even number from the box that there were 10 odd and 10 even numbers in it. Even number group were in intervention group and odd number group were in control group at first week.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Beheshty University of Medical Sciences
Street address
No. 209, Sheikh Akbari Ave., Rey City
City
Tehran
Province
Tehran
Postal code
1841936545
Approval date
2017-11-03, 1396/08/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.572

Health conditions studied

1

Description of health condition studied
The effect of stimulating massage on knee joint position sense
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Absolute error
Timepoint
Before and After intervention
Method of measurement
Motion Analysis

2

Description
Relative error
Timepoint
Before and after intervention
Method of measurement
Motion analysis

Secondary outcomes

1

Description
Variable error
Timepoint
Before and after intervention
Method of measurement
Motion analysis

Intervention groups

1

Description
Intervention group: 10 minutes stimulating massage of knee flexor and extansor muscles, 1minutes stroking, 1min hacking, 1min cupping and 7min petrissage in one session and measuring of knee joint position sense by motion analysis SIMI-GS108PEv2 made in China(before and after massage).
Category
Treatment - Other

2

Description
Control group: 10 minutes resting without intervention and measuring of knee joint position sense by motion analysis(before and after resting).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Park
Full name of responsible person
Mohammad Moradi
Street address
No. 209, SheikhAkbari Ave., Rey City
City
Rey
Province
Tehran
Postal code
1841936545
Phone
+98 21 5592 9986
Email
mahmoudakramzade@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
DR Farideh Dehghan Monshadi
Street address
Beheshty Rehabilitation Faculty., Damavand Aven., Booali Hospital
City
Tehran
Province
Tehran
Postal code
1841936545
Phone
+98 21 7754 8496
Email
mahmoudakramzade@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahmoud Akramzade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 209, Sheikh Akbari Ave., Rey City
City
Tehran
Province
Tehran
Postal code
1841936545
Phone
+98 21 5592 9986
Email
mahmoudakramzade@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahmoud Akramzade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 209, Sheikh Akbari Ave., Rey City
City
Tehran
Province
Tehran
Postal code
1841936545
Phone
+98 21 5592 9986
Email
mahmoudakramzade@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahmoud Akramzade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 209, Sheikh Akbari Ave., Rey City
City
Tehran
Province
Tehran
Postal code
1841936545
Phone
+98 21 5592 9986
Email
mahmoudakramzade@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are not more information
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
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