Purpose: To compare the effect of lateral wedge insole on lateral trunk lean motion in knee osteoarthritis to lateral wedge insole with subtalar strap.
Method: 23 patients aged over 40 years with medial compartment knee osteoarthritis in one knee according to American College of Rheumatology criteria were participated in this study. They were excluded if they had bilateral knee osteoarthritis and secondary arthritis. Participants were tested in 3 conditions while walking through 3 meters walkway: without insole, lateral wedge insole and lateral wedge insole with subtalar strap. The insoles were made of High density Ethyl Vinyl Acetate with leather covered. They had 5 degree lateral wedge for involved limb and were neutral for contra lateral limb.
A six camera Vicon motion analysis system was used to measure lateral trunk lean motion. 5 passive reflective markers were placed on left and right acromioclavicular joints, right and left anterior superior iliac spines and on sacrum. The immediate effect of lateral wedge insole with and without subtalar strap was compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104185520N4
Registration date:2011-04-29, 1390/02/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-29, 1390/02/09
Registrant information
Name
Mojtaba Kamyab
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
kamyab@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Tehran University of medical sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lateral wedge insole with and without subtalar strap on lateral trunk lean motion in knee osteoarthritis
Public title
The effect of lateral wedge insole with and without subtalar strap in patients with genoarthrosis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion Criteria:
1. age between 35 to 50 years
2. at least 3 level of pain based on a ten level visual analogue scale
3. radiographic osteophyte at the joint space
4. normal or mild varus knee joint malalignment and unilateral medial tibiofemoral knee osteoarthritis
5. grade I or II of knee osteoarthritis based on Kellgren and Lawrence knee osteoarthritis grading system.
Exclusion Criteria:
1. bilateral knee osteoarthritis
2. grade III or higher of knee osteoarthritis
3. secondary knee osteoarthritis caused by trauma, knee joint surgery or other rare forms of arthritis
4. significant knee joint ligament laxity
5. previous knee joint fracture
6. therapeutic knee joint injection in previous 6 months
7. nervous system disorder that made some problems in voluntary movement
8. perception disorder
9. chronic back pain
10. lower limb discrepancy
11. experience of any orthotic treatments in knee joint or foot region
12. BMI more than 36 Kg/m2
13. hip joint or lumbar joints arthritis
14. hallux stiffness, midfoot valgus deformity, hindfoot arthropathy, foot ligament laxity, flat foot or any other problems that caused restriction for use of insole
15. knee joint valgus malalignment or knee joint recurvatum
16. problems which limited independent walking
Age
From 40 years old to 54 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences, Rehabilitation school
Street address
Research committee, Rehabilitation School, Tehran University of Medical Sciences, Shahnazari St., Mirdamad Blvd.
City
Tehran
Postal code
Approval date
2010-11-02, 1389/08/11
Ethics committee reference number
265
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
primary gonarthrosis, Unilateral
Primary outcomes
1
Description
Lateral Trunk lean angle
Timepoint
before using insole and immediatly after using insole with and without subtalar strap
Method of measurement
6 camera Vicon Motion analysis system
Secondary outcomes
1
Description
walking speed
Timepoint
before using insole and immediatly after using insole with and without subtalar strap
Method of measurement
Vicon motion analysis system with 6 cameras
Intervention groups
1
Description
Lateral wedge insole and subtalar strap with Gymnastic shoes
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Welfare and Rehabilitation Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr M. Moradi Lakeh
Street address
Vice-chancellor for Research, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rehabilitation School, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Kamyab
Position
PhD of Orthotics and Prosthetics
Other areas of specialty/work
Street address
Orthotics and Prosthetics Department, Rehabilitation School, Tehran University of Medical Sciences, Shahnazari St., Mirdamad Blvd
City
Tehran
Postal code
Phone
+98 21 2222 0947
Fax
Email
m-kamyab@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rehabilitation School, Tehran University of Medical Sciences
Full name of responsible person
Elham Esfandiari
Position
Master student of orthotics and prosthetics
Other areas of specialty/work
Street address
Department of orthotics and prosthetics, Rehabilitation school, Tehran University of Medical Sciences, Shahnazari St., Mirdamad Blvd
City
Tehran
Postal code
Phone
+98 21 2399 2117
Fax
Email
esfandiari.elham@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rehabilitation school, Tehran University of Medical Sciences
Full name of responsible person
Elham Esfandiari
Position
Master student of orthotics and prosthetics
Other areas of specialty/work
Street address
Department of orthotics and prosthetics, Rehabilitation shool, Tehran University of Medical Sciences, shahnazari st., Mirdamad Blvd
City
Tehran
Postal code
Phone
+98 21 2399 2117
Fax
Email
esfandiari.elham@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)