The hypothesis of this study is based on adding balance training to the ordinary physiotherapy, can improve functional state of patients with knee osteoarthritis. Sixty patients with mild to moderate knee osteoarthritis (age between 50 to 65 years) are set in two intervention and control groups randomly. Knee physiotherapy will be done in both groups. In addition, we will add balance training during 10 sessions on intervention group. Before and after study, functional tests as WOMAC, Lequesne questionnaire and falling risk with balance system would be tested to compare between 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008274641N1
Registration date:2011-09-21, 1390/06/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-21, 1390/06/30
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Physical medicine and rehabilitation center of Tabriz
Expected recruitment start date
2010-05-05, 1389/02/15
Expected recruitment end date
2011-07-06, 1390/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of balance training with conventional physiotherapy on clinical improvement of knee osteoarthritis
Public title
The effect of balance training with conventional physiotherapy on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 50 to 65 years; knee joint stiffness less than 30 minutes; mild to moderate knee osteoarthritis. Exclusion criteria: severe osteoarthritis (grade iv) according to ACR classification; secondary osteoarthritis; acute synovitis.
Age
From 50 years old to 65 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)
Single 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
Golgasht st
City
Tabriz
Postal code
Approval date
2011-08-15, 1390/05/24
Ethics committee reference number
9025
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
functional improvement
Timepoint
Before and after 10 sessions of physiotherapy
Method of measurement
WOMAC & Lequesne Questionnaires
Secondary outcomes
1
Description
pain severity
Timepoint
before and after 10 sessions of physiotherapy
Method of measurement
WOMAC and Lequesne quastionnaires
2
Description
fall risk decrease
Timepoint
Before and after 10 sessions of physiotherapy
Method of measurement
bidex balance system
Intervention groups
1
Description
Control group: only routine physiotherapy include TENS (Transcutaneous Electrical Nerve Stimulation), Ultrasound, Hot pack for 10 session.
Category
Rehabilitation
2
Description
Intervention group: routine physiotherapy with balance training
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital of Tabriz
Full name of responsible person
Bina Eftekharsadat
Street address
Shohada hospital, Parvaz street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation Research Center of Tabriz
Full name of responsible person
Yaghoub Salek Zamani
Street address
Imam reza hospital , Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation Research Center of Tabriz
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
Physical medicine and rehabilitation center of Tabriz
Full name of responsible person
Bina Eftekharsadat
Position
Associate professor
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Research Center of Tabriz, imam reza hospital, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1336 4672
Fax
Email
binasadat@yahoo.com ; binasadat@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physical medicine and rehabilitation center of Tabriz
Full name of responsible person
Bina Eftekharsadat
Position
Associate professor
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Research Center of Tabriz, Imam reza hospital, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1336 4672
Fax
Email
binasadat@yahoo.com ; binasadat@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Physical medicine and rehabilitation center of Tabriz
Full name of responsible person
Alireza Bihamta
Position
Medical student (Intern)
Other areas of specialty/work
Street address
Physical Medicine ad Rehabilitation Research Center of Tabriz, Imam reza hospital, Golgasht street
City
Tabriz
Postal code
5137945854
Phone
+98 41 1551 2646
Fax
Email
bihamta1@gmail.com ; bihamta@post.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)