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Evaluation of new ankle foot orthosis for patients with medial compartment osteoarthritis of the knee and Pilot study for evaluation of it’s effect on joint contact force, gait parameters, function, usability, pain and quality of life

Protocol summary

Study aim
Evaluation of a new foot-ankle orthosis for patients with internal compartment osteoarthritis (OA) of the knee and a preliminary study of its effect on intra-articular force, gait parameters, performance, applicability, pain and quality of life of patients
Design
After the construction of the orthosis, the second phase of the pilot study in the form of a semi-experimental before and after study, the impact of the orthosis on clinical parameters (pain, symptoms, daily life activities, quality of life, satisfaction with the orthosis, comfort, fear of falling) and biomechanical will be investigated on ten patients with knee osteoarthritis
Settings and conduct
In order to perform the relevant tests, the patients are asked to walk along a certain path in the laboratory. Before the test, the patients get familiar with the laboratory environment and how to perform the test is explained to them. The place of the study is the Technical Orthopedics Department of the Faculty of Rehabilitation in Isfahan University of Medical Sciences and the study population is 10 patients with knee arthritis. No blinding will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 50 years old; The severity of knee osteoarthritis be mild to moderate (grade 2 or 3) based on radiographic findings and the Kellgren-Lawrence scale; Mild to moderate pain intensity (based on VAS scale, mild pain = 0-3, moderate pain = 4-6); Mild varus alignment in the knee with symptoms of osteoarthritis of the internal compartment of the knee. Exclusion criteria: History of knee joint replacement surgery; External compartment osteoarthritis (grade 1 and above); Having any cognitive or neurological disorder (Parkinson's, MS, etc.); The patient is undergoing physiotherapy treatment or using other orthotic treatment.
Intervention groups
The research intervention includes a foot orthosis that covers the foot, ankle and part of the leg.
Main outcome variables
Pain; quality of life; inter-articular force

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200516047459N7
Registration date: 2023-06-12, 1402/03/22
Registration timing: prospective

Last update: 2023-06-12, 1402/03/22
Update count: 0
Registration date
2023-06-12, 1402/03/22
Registrant information
Name
Masoud Rafiaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5043
Email address
ma.rafiaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of new ankle foot orthosis for patients with medial compartment osteoarthritis of the knee and Pilot study for evaluation of it’s effect on joint contact force, gait parameters, function, usability, pain and quality of life
Public title
Evaluation of AFO on knee OA
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 50 years The severity of knee osteoarthritis be mild to moderate (grade 2 or 3) based on radiographic findings and the Kellgren-Lawrence scale Mild to moderate pain intensity (based on VAS scale, mild pain = 0-3, moderate pain = 4-6) Mild varus alignment in the knee with symptoms of osteoarthritis of the internal compartment of the knee Reporting of knee pain in most weekdays at least in the last month Not having movement restrictions in walking and standing Walking without any aids
Exclusion criteria:
History of knee replacement surgery History of lower limb fracture or knee ligament damage in the last year External compartment osteoarthritis (grade 1 and above) Having any cognitive or neurological disorder The patient is undergoing physiotherapy treatment or using other orthotic treatment
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-11-26, 1401/09/05
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.111

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
M15.9
ICD-10 code description
Polyosteoarthritis, unspecified

Primary outcomes

1

Description
Force inside the knee joint
Timepoint
Before and six weeks later
Method of measurement
force plate

2

Description
pain
Timepoint
Before and six weeks later
Method of measurement
Before and six weeks later

3

Description
quality of life
Timepoint
Before and six weeks later
Method of measurement
Before and six weeks later

Secondary outcomes

empty

Intervention groups

1

Description
This pilot study will be conducted on ten patients with internal compartment osteoarthritis. Sampling will be done by easy non-random method and the subjects will be selected from the patients referred to the orthopedic clinic who meet the conditions to enter the study. Informed and voluntary consent form will be obtained. The diagnosis of osteoarthritis of the knee will be confirmed by a specialist doctor, and information about the patient will be extracted using paraclinical measures, radiography and CT scan. The severity of osteoarthritis of patients will be determined by a specialist based on the Kellgren-Lawrence scale. In order to perform tests related to the measurement of time-spatial variables of walking, range of motion of joints, torques and contact forces of inter-articular surfaces, patients are asked to walk along a certain path in the laboratory and their information will be recorded by cameras. The orthosis covers the area of the sole of the foot up to the lower two-thirds of the leg, and by applying force in this area, it will have an indirect effect on the knee. After evaluating the patient and designing the orthosis and the place of application of force, the orthosis is made.The patient will be taught how to wear the orthosis and wear it for at least 4 hours a day during these 6 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Street address
No.318 , Rehabilitation college, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@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
No.318 , Rehabilitation college, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
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
Masoud Rafiaei
Position
member of faculty
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
No.318 , Rehabilitation college, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
member of faculty
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
No.318 , Rehabilitation college, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
member of faculty
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
No.318 , Rehabilitation college, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com

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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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