Protocol summary

Summary
Introduction:Osteoarthritis (OA) is one of the prevalent disease in Joints.The Knee joint is the most frequently involved than other joint to OA.the research had shown quadriceps muscles weakness and proprioceptive deficits in patient related to knee osteoarthritis.The pharmacological treatment approaches that are used for management of knee OA, only reduce pain and swelling, on the other hand,these approaches have different complication with them.So using none-pharmacological treatments such as exercise performing, are very importants. The aim of this study is evaluation of the effect of isokinetic exercise with conventional physiotherapy on power and rate of Stiffness in patieuts with knee osteoarthritis. Methods: In this study with type " single blinded semi practical clinical traits" 30 women patient with mild to moderate knee osteoarthritis without pregnancy in age from 45-65 were used and divided into two groups (control and treatment). Exit criteria of this study were acute disease, existence of pain doing exersice and the intensification of pain under exercise. the first group (as control group) recevived routine knee physical therapy modalities; the second group (as isokenitec training group) in addition to routine protocol received isokinetic training. Rate of stiffens by questioner of Western Ontario McMasters Osteoarthritis index ( WOMAC), and their power was evaluated by biodex4.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016070727359N3
Registration date: 2017-03-06, 1395/12/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-06, 1395/12/16
Registrant information
Name
Seyed Kazem Shakouri
Name of organization / entity
Tabriz University of Medical Sciences, Physical mediacine and rehabilitation department
Country
Iran (Islamic Republic of)
Phone
+98 33364672
Email address
shakorik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz Medical Science University
Expected recruitment start date
2016-05-23, 1395/03/03
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of isokinetic exercise with conventional physiotherapy on power in patieuts with knee osteoarthritis.
Public title
The effect of isokinetic exercise in patieuts with knee osteoarthritis.
Purpose
Other
Inclusion/Exclusion criteria
inclusion criteria: patient with mild to moderate knee osteoarthritis without pregnancy in age from 45-65, existence of balance, lack of skin wound about knee. Exclusion criteria: acute disease, existence of pain doing exersice and the intensification of pain under exercise, surgery background in knee joint.
Age
From 45 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Ethics Comittee, Tabriz Medical Science University
Street address
Tabriz Medical Science University, Golgasht street
City
Tabriz
Postal code
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
IR.TBZMED,REC.1395.275

Health conditions studied

1

Description of health condition studied
knee Osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
knee Osteoarthritis

Primary outcomes

1

Description
Power Increasing
Timepoint
Before, After 6 sessions and after intervention
Method of measurement
Biodex 4

Secondary outcomes

1

Description
Rate of Stiffness
Timepoint
Befor, After 6 sessions and after intervention
Method of measurement
Biodex 4

Intervention groups

1

Description
Interventional group sit on chair of biodex 4 and then resistance pad of device was placed the top of leg ankle. Movement domain in range of flexion and full extension, and damping device was regulated hard. Concentric contraction with 10 to 90 degree, the 60-90 speed, 10 replications with six set (between sets 30 -60 second was given rest) defined for biodex4
Category
Rehabilitation

2

Description
For the first group (as control group) received routine knee physical therapy modalities.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation Research Center
Full name of responsible person
Seyed kazem Shakouri MD
Street address
Physical Medicine and Rehabilitation ward, Imam Reza hospital, Golgasht St.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of research, Tabriz Medical Science University
Full name of responsible person
Seyed kazem Shakouri. MD
Street address
Tabriz Medical Science University, Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Tabriz Medical Science University
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Physical Medicine and Rehabilitation Group, Tabriz Medical Science University
Full name of responsible person
Seyed kazem Shakouri
Position
Professor
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation ward, Imamreza Hospital, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 3336 1928
Fax
Email
shakourik@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Corrective Exercises and Sport Traumatology
Full name of responsible person
Ameneh Abdollahi
Position
MA/ Researcher
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation ward, Imamreza Hospital, Golgasht St.H
City
Tabriz
Postal code
Phone
+98 41 3658 8075
Fax
Email
abdollah.tab66@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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