Adding calf muscles physical therapy to the ordinary physiotherapy, can improve functional state of patients with knee osteoarthritis. Sixty patients are set in two intervention and control groups randomly. In intervention group we will add calf muscles strengthening and stretching exercises on knee physiotherapy during 20 sessions. Before and after program, functional tests as WOMAC, Lequesne questionnaire and falling risk with balance system would be tested to compare groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808132664N1
Registration date:2009-12-18, 1388/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-12-18, 1388/09/27
Registrant information
Name
Yaghoub Salekzamani
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3967
Email address
salekzamaniy@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz Univercity of medical sciences
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2010-01-21, 1388/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of leg muscles exercise on clinical improvement of knee osteoarthritis
Public title
Effect of leg muscles exercise on clinical improvement of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: moderate knee osteoarthritis
Exclusion criteria: severe systemic illness, joint injection, surgery or physical therapy within last six months
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of medical sciences
Street address
Imam Reza Hospital
City
Tabriz
Postal code
Approval date
2009-04-01, 1388/01/12
Ethics committee reference number
173/4/5
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M19
ICD-10 code description
Other arthrosis
Primary outcomes
1
Description
Functional improvment
Timepoint
Before and after 20 sessions of physiotherapy
Method of measurement
WOMAC & Lequesne Questionnaires
Secondary outcomes
1
Description
Falling Risk
Timepoint
Before and after 20 sessions of physiotherapy
Method of measurement
Biodex Balance system
Intervention groups
1
Description
Control group: only routine physiotherapy
Category
Rehabilitation
2
Description
Intervention group: routine physiotherapy and calf musles strengthening and stretching excercises
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospital
Full name of responsible person
Yaghoub Salekzamani
Street address
Golgasht st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice-chancellor of Tabriz univercity of medical sciences
Full name of responsible person
Mir Ali Eteraf Oskouee
Street address
Tabriz univercity of medical sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice-chancellor of Tabriz univercity 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
Tabriz university of medical sciences
Full name of responsible person
Yaghoub Salekzamani
Position
Assistant professor
Other areas of specialty/work
Street address
Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1337 3967
Fax
Email
salekzamaniy@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz univercity of medical sciences
Full name of responsible person
Yaghoub Salekzamani
Position
Assistant professor
Other areas of specialty/work
Street address
Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1337 3967
Fax
Email
salekzamaniy@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz univercity of medical sciences
Full name of responsible person
Babak Kolahi
Position
Resident
Other areas of specialty/work
Street address
Golgasht St.
City
Tabriz
Postal code
Phone
Fax
Email
kolahi_md@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)