Design and manufacturing of new “ankle foot orthosis for knee osteoarthritis” and evaluation of its effect on knee addaction moment and gait kinetic parameters in people with knee osteoarthritis.
Design and manufacturing of new “AFO” and evaluation of its effect on knee addaction moment and kinetic parameters of gait in people with knee OA
Design
Study design: Before- after design clinical trial.
ُSample size: 28 subjects with medial compartment knee OA
Study phases: Before wearing the orthosis and when wearing the orthosis
Settings and conduct
The current study will be carried out in faculty of rehabilitation science of Iran university of medical sciences and on the hospital outpatients who had prescribed by an orthopedic physician to use a knee orthosis.
Participants/Inclusion and exclusion criteria
Inclusion Criteria Medial compartment knee OA with grade 2 or 3 of KL scale Age range 35- 70 years old BMI range 18.5 - 35 Exclusion Criteria Lateral compartment knee OA Rheumatoid Arthritis Osteoarthritis of ankle or hip or vertebral column or patellofemoral joint Chronic or severe disturbances that lead to change in the gait pattern of the participants and can be recognized by the researchers observational assessment. History of operation in lower limb History of injection or operation in the last 6 months
Intervention groups
Intervention group: people with knee osteoarthritis after wearing "َAFO for Knee OA" orthosis.
Control group: people with knee osteoarthritis before wearing "َAFO for Knee OA" orthosis.
Main outcome variables
Comport- Knee addaction moment- Kinetic parameters when walking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160904029684N3
Registration date:2019-03-19, 1397/12/28
Registration timing:prospective
Last update:2019-03-19, 1397/12/28
Update count:0
Registration date
2019-03-19, 1397/12/28
Registrant information
Name
Kourosh Barati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 935 882 7110
Email address
barati.k@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-03, 1398/01/14
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and manufacturing of new “ankle foot orthosis for knee osteoarthritis” and evaluation of its effect on knee addaction moment and gait kinetic parameters in people with knee osteoarthritis.
Public title
Design and manufacturing of "new orthosis for knee osteoarthritis" and evaluation of its effect on gait in people with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Medial compartment knee OA with grade 2 or 3 of KL scale
Age range 35- 70 years old
BMI range 18.5 - 35
Exclusion criteria:
Lateral compartment knee OA
Rheumatoid Arthritis
Osteoarthritis of ankle or hip or vertebral column or patellofemoral joint
Chronic or severe disturbances that lead to change in the gait pattern of the participants and can be recognized by the researchers observational assessment.
History of operation in lower limb
History of injection or operation in the last 6 months
Age
From 35 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
28
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 Iran University of Medical Science
Before wearing orthosis and after wearing orthosis
Method of measurement
Force plate synchronized with the motion analysis instrument
2
Description
Comfort
Timepoint
Before wearing orthosis and after wearing orthosis
Method of measurement
questionnaire
3
Description
Kinetic parameters
Timepoint
Before wearing orthosis and after wearing orthosis
Method of measurement
Force Plate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants with knee OA will perform the biomechanical test in three conditions: when wearing no orthosis, when wearing "AFO for Knee OA" Orthosis with un-lucked supination/pronation joint and when wearing "AFO for Knee OA" Orthosis with lucked supination/pronation joint.