The Effect of Mulligan Mobilization Technique with Conventional Physical Therapy on Balance in Patients with Moderate to Severe Knee Osteoarthritis
Design
Randomized Controlled Trial , Two Groups of treatment and Control with a Sample Size of 20 in each Group , Factorial Groups , double blind , Simple Randomised
Settings and conduct
This Study will be done in Physiotherapy Clinic of Isfahan University of Medical Sciences on Patients with Knee Osteoarthritis in Two Groups of Treatment and Control.Treatment of Treatment Group is Conventional Physical Therapy and Mulligan Mobilization and Control Group is Conventional Physical Therapy.
Double Blind Study; Participates and Investigator of Inclusion and Exclusion Criteria and Patient Balance.
Participants/Inclusion and exclusion criteria
Inclusion Criteria; Moderate to Severe Unilateral Knee Osteoarthritis; Painful often; Independent in Standing and Walking
Exclusion Criteria; any Active Knee Infection; Knee Surgery and Steroid Injection; any Musculoskeletal Disorder in Lower Limb and Low Back; any Orthopedic and Neurology and Rheumatoid Impairment Affected Balance; Sensory Loss;Uncorrected Visual and Vestibular Impairment
Intervention groups
Treatment Group, Conventional Physical Therapy with Mulligan Mobilization
Control Group, Conventional Physical Therapy
Main outcome variables
Balance Improvement
Prevention and Decrease Falling in Patients with Knee Osteoarthritis
Decrease Pain
Increase knee Range of Motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181009041297N1
Registration date:2018-11-24, 1397/09/03
Registration timing:registered_while_recruiting
Last update:2018-11-24, 1397/09/03
Update count:0
Registration date
2018-11-24, 1397/09/03
Registrant information
Name
Maryam Adeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3376 9071
Email address
m.adely@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mulligan Mobilization on Static and Dynamic Balance in Patients with Moderate to Severe Knee Osteoarthritis.
Public title
Effect of Mulligan Mobilization Technique on Balance in Knee Osteoarthritis
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to Severe Knee Osteoarthritis
Independent in Walking and Standing
Knee Pain on Most Days of the Previous Month
Unilateral Knee Pain
Exclusion criteria:
Active Infection in Knee Joint
Patellofemoral Osteoarthritis
Any Knee Surgery
Any Musculoskeletal Disorder in Lower Limb and Low Back
Severe Psychology Disorders
Rheumatoid Arthritis
Uncorrected Visual and Vestibular Impairment
Tendon and Ligament Injuries
Steroid Injection(3 month ago)
Any Sensory Loss in Feet(diabetic)
Unwilling to Participate
Any orthopedic and Neurology Impairment Affected on Balance
Fixed Knee Range of Motion
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this Study, Patients will Divide to two Groups Control and Treatment , through Simple Random Sampling by Flipping a Coin to Decide which Patient Goes to Control or Treatment Groups? in this way if one Group is Completed Quickly ,other Patients Go to another Group
Blinding (investigator's opinion)
Double blinded
Blinding description
In this Study, Participants are Aware of the Study's Research and the Type of Groups and Treatment, but They do not know what they are Receiving. Investigator of Inclusion and Exclusion Criteria and Balance Tests Before and After the Treatment and Analyzer of Data are also Blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Shahid Mirza Mohammad Barati Alley , Navab Safavi Avenue
City
Dorche
Province
Isfehan
Postal code
8431833531
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.MUI.REC.1397.30135
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis
Primary outcomes
1
Description
Static and Dynamic Balance
Timepoint
Before and after treatment( Ten sessions)
Method of measurement
Duration of Maintaining Static Balance through One Leg Stance Test and Duration of Dynamic Balance through Time up and go Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Conventional physical Therapy( pain relief and knee muscles strengthening exercises) and Mulligan Mobilization(a treatment technique)
Category
Diagnosis
2
Description
Control group: Conventional physical Therapy( pain relief and knee muscles strengthening exercises)
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Alzahra Hospital
Full name of responsible person
Maryam Adeli
Street address
Alzahra Hospital, Sofe Avenue
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Hagh joy Javanmard
Street address
Isfahan University of Medical Science, Hezar jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Adeli
Position
Physiotherapy Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shahid mirza Mohammad Barati, Navab Safavi Avenue
City
Dorche
Province
Isfehan
Postal code
8431833531
Phone
+98 31 3376 9071
Email
M.adely@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Adeli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shahid Mirza Mohammad Barati, Navab Safavi Avenue
City
Dorche
Province
Isfehan
Postal code
8431833531
Phone
+98 31 3376 9071
Email
M.adely@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Adeli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shahid Mirza Mohammad Barati, Navab Safavi Avenue
City
Dorche
Province
Isfehan
Postal code
8431833531
Phone
+98 31 3376 9071
Email
M.adely@rehab.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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