Protocol summary

Study aim
The effects of mobilization with movement (MWM) technique on the center of pressure sway in a functional position and its situation in the base of support in knee osteoarthritis
Design
Randomized clinical trial, with control group, 20 patients with moderate knee osteoarthritis and 10 healthy individuals
Settings and conduct
To perform medial mulligan glide, the patient was in prone position. The therapist closed a belt around her waist and down the patient's knee. Then, while she fixes the thigh and supports leg , she performed glide. The patient should have flex or extend her knee at the same time dependent of the direction of limitation. The lateral mulligan glide was also applied to the lateral direction. The exercise group received only therapeutic exercise. The exercise program was similar to the MWM group. All stages of the study were conducted at Tarbiat Modares University.
Participants/Inclusion and exclusion criteria
Inclusion Criteria 1. Unilateral or bilateral knee OA with severe pain in one knee 2. Kellgren and Lawrence 2,3 3. Age 45-70 Exclusion Criteria: 1. Discontinuing of cooperation for any reason 2.Change in patient’s situation that leads to loose inclusion criteria 3.Not complete treatment plan 4. History of: severe musculoskeletal weakness lower limb surgery Calcaneal eversion >15 and calcaneal inversion >10 osteoporosis knee valgus>15 and knee varus> 10
Intervention groups
Control group received 10 sessions of exercise therapy. The Mulligan group received 6 sessions of MWM techniques in addition to 10 sessions of exercise therapy.
Main outcome variables
pain severity, quality of life, functional balance, dynamic balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101017004952N6
Registration date: 2019-03-11, 1397/12/20
Registration timing: retrospective

Last update: 2019-03-11, 1397/12/20
Update count: 0
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Giti Torkaman
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4509
Email address
torkamg@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2018-03-16, 1396/12/25
Trial completion date
2018-11-21, 1397/08/30
Scientific title
The Effects of Mobilization with Movement (MWM) Technique on the Center of Pressure Sway in the Functional Positions and Its Changes in the Base of Support in Subjects with Knee Osteoarthritis
Public title
The effects of MWM techniques on the center of pressure sway changes in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral or bilateral knee osteoarthritis (OA) with severe pain in one knee Grade II OA according to Kellgren and Lawrence Pain for at least 3 months Normal blood pressure 140/90 Age 45-70 Muscle strength at least 3 using dynamometer
Exclusion criteria:
Participating muscle strengthening plan at least for 3 months ago Severe muscle weakness Meniscal lesions Lower limb surgery Serious systemic or nervous disease Visual disturbance Vestibular, neurologic, neuromuscular & chronic orthopedic disease Joint injury Hard flat foot Calcaneal eversion >15 and calcaneal inversion >10 Corticosteroid injection in 6 months ago Suffering any other arthritis Osteoporosis Knee valgus>15 and knee varus> 10
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Actual sample size reached: 10
Randomization (investigator's opinion)
Randomized
Randomization description
By blocked randomization method, subjects were assigned to the Mulligan group and the exercise group. The blocks of 5 were used for randomized allocation of subjects to the groups. First, the list of blocks was written and numbers 1 or 2 assigned to them. After the random selection of the number, the treatment allocation was done based on the selected number.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Committee of Ethics in Biomedical Research of Tarbiat Modares University
Street address
Jalal AleAhmad Ave., Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2017-10-24, 1396/08/02
Ethics committee reference number
IR.TMU.REC.1396.643

Health conditions studied

1

Description of health condition studied
Knee osteoartritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Balance
Timepoint
Balance assessment before and 3 weeks after training
Method of measurement
Force plate

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group received 10 sessions of exercise therapy with 6 sessions (twice a week) of MWM techniques. In the first step, we assessed the region of pain and direction of restriction. Then, we decided which technique for use. Medial glide for medial pain and lateral glide for lateral pain, was done. The direction of restriction (flexion or extension) showed us the direction of movement. Internal rotation glide for all patients was performed.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Dr Giti Torkaman
Street address
Jala AleAhmad Ave., Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8286 0000
Email
abdolahiannajmeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Giti Torkaman
Street address
Jala AleAhmad Ave., Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
torkamg@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Dr Giti Torkaman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal AleAhmad Ave., Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
torkamg@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Giti Torkaman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal AleAhmad Ave., Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
torkamg@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Najmeh Abdollahian
Position
Graduated
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jalal AleAhmad Ave., Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
abdolahiannajmeh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data will be shared after confirmation of chief researcher.
When the data will become available and for how long
6 months after publication
To whom data/document is available
All researchers
Under which criteria data/document could be used
For scientific purposes
From where data/document is obtainable
Dr Giti Torkaman
What processes are involved for a request to access data/document
Confirmation of chief researcher
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