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Evaluation of the immediate effect of distractive “KIA-knee” knee brace on reduction of adduction moment and pain in patients with knee osteoarthritis

Protocol summary

Study aim
Investigating the immediate effect of “KIA-knee” knee brace on knee adduction and flexion moment, knee angle in the frontal plane, ground reaction force and pain in patients with knee osteoarthritis
Design
The study is clinical trial without a control group. The sample size is 16 people and sampling is done by random method. In this research, only one group is studied, and our intervention is distractive “KIA-knee” knee brace.
Settings and conduct
This research is carried out in the Skeletal-Muscular Research Center, Isfahan University of Medical Sciences.16 people with knee osteoarthritis are evaluated and the evaluations include gait test and pain questionnaire in two situations with knee brace and without knee brace.
Participants/Inclusion and exclusion criteria
Conditions for entering: suffering from osteoarthritis of the medial compartment of the knee, mild or moderate severity, age range of 40 to 70 years, the level of pain (VAS index) equal to or greater than 4, the severity of knee varus deformity in the anterior-posterior view is 2 to 11 degrees, BMI is equal to or less than 35, no injection of hyaluronic acid or corticosteroids in the last 6 months, no use of other orthoses; Exit conditions: indication for knee joint surgery, suffering from simultaneous osteoarthritis of the hip or ankle joints or feet on the same or opposite side, heart or lung diseases, rheumatoid arthritis, skin disorders, infection, diabetes, Acute inflammation of the knee, deep vein thrombosis, a history of stroke and history of knee arthroplasty surgery
Intervention groups
In this study, 16 people with knee osteoarthritis receive a type of distractive knee brace that called “KIA-knee” knee brace and this study does not include the control group.
Main outcome variables
Pain score, knee adduction and flexion moment, knee angle in the frontal plane and ground reaction force

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220824055786N1
Registration date: 2022-09-24, 1401/07/02
Registration timing: prospective

Last update: 2022-09-24, 1401/07/02
Update count: 0
Registration date
2022-09-24, 1401/07/02
Registrant information
Name
Maryam Abbasi dashtaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 7950
Email address
maryam.abasi.d76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-12-31, 1401/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the immediate effect of distractive “KIA-knee” knee brace on reduction of adduction moment and pain in patients with knee osteoarthritis
Public title
Evaluation of the immediate effect of distractive “KIA-knee” knee brace on reduction of adduction moment and pain in patients with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having medial knee osteoarthritis The severity of osteoarthritis is mild or moderate (Kelgren-Lawrence classification) based on the graph prepared in the last 6 months Has an age range of 40 to 70 years The amount of pain at rest (VAS index) is equal to or more than 4 Severity of knee varus deformity based on graph in anterior-posterior view is 2 to 11 degrees BMI is equal to or less than 35 No injections of hyaluronic acid or corticosteroids in the last 6 months No use of other orthoses
Exclusion criteria:
Indications for knee joint surgery according to the opinion of an orthopedic specialist Suffering from concurrent arthritis of hip or ankle joints or feet on the same or opposite side Having heart or lung diseases, rheumatoid arthritis, skin disorders, infection, diabetes, acute knee inflammation, knee pain caused by other factors or deep vein thrombosis History of stroke History of fracture around the knee or total or partial knee arthroplasty surgery
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Faculty of Rehabilitation, Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-08-20, 1401/05/29
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.062

Health conditions studied

1

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

Primary outcomes

1

Description
Knee adduction moment
Timepoint
Measurement of the knee adducton moment in gait before and after using distractive “KIA-knee” knee brace.The immediate effect is investigated.
Method of measurement
Visual 3D motion analysis software

2

Description
Knee flexion moment
Timepoint
Measurement of the knee flexion moment in gait before and after using distractive “KIA-knee” knee brace.The immediate effect is investigated.
Method of measurement
Visual 3D motion analysis software

3

Description
Ground reaction force
Timepoint
Measurement of the ground reaction force during gait before and after using distractive “KIA-knee” knee brace.The immediate effect is investigated.
Method of measurement
Force plate

4

Description
Knee angle in the frontal plane
Timepoint
Measurement of the knee angle in the frontal plane during gait before and after using distractive “KIA-knee” knee brace.The immediate effect is investigated.
Method of measurement
Visual 3D motion analysis software

5

Description
Pain
Timepoint
Measuring the amount of pain before and after using distractive “KIA-knee” knee brace based on Visual Analogue Scale
Method of measurement
The pain questionnaire, which includes a 10 cm line, and the person participating in the study shows his pain level as a vertical line on this scale before and after using the knee brace.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, for 16 patients with knee osteoarthritis, distractive “KIA-knee” knee brace will be designed and manufactured in the appropriate size for each patient. This knee brace is a redesigned example of OA Knee Trac Brace and by the triangular leverage traction system used in the joint of the knee brace, the weight is removed from both compartments when the knee position is changed from flexion to extension. Evaluations are done in 2 stages with knee brace and without knee brace.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Dr. Hamid Mousavi
Street address
Orthopedic clinic, Al-Zahra specialized hospital, Shohday sofe Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
maryam.abasi.d76@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@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
ِِ ِDr. Hossein Asiyaeimehr
Position
Assistant professor and faculty member of Orthotics and Prosthetics department
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Faculty of Rehabilitation, Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5081
Fax
+98 31 3668 7270
Email
asiyaeimehr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Hossein Asiyaeimehr
Position
Assistant professor and faculty member of Orthotics and Prosthetics department
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Faculty of Rehabilitation, Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5081
Fax
+98 31 3668 7270
Email
asiyaeimehr@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
ِDr. Hossein Asiyaeimehr
Position
Assistant professor and faculty member of Orthotics and Prosthetics department
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics and Prosthetics
Street address
Faculty of Rehabilitation, Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5081
Fax
+98 31 3668 7270
Email
asiyaeimehr@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study information (other than individual information) will be shared with other researchers.
When the data will become available and for how long
Information will be shared after results or data summaries are published.
To whom data/document is available
Information will be shared for academic purposes only.
Under which criteria data/document could be used
Information is shared for the teaching and research of applicants.
From where data/document is obtainable
People can request information from the introduced responsible person.
What processes are involved for a request to access data/document
Requests must be sent via email (asiyaeimehr@gmail.com).
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