Conservative management is considered as the cornerstone of knee osteoarthritis treatment. Balance and locomotion problems are still under question in mild knee osteoarthritis. Therefore, the aim of this study is considering posture and locomotion coupling in gait initiation and the effect of lateral wedge insole on gait initiation. Patients with mild knee osteoarthritis of the medical compartment of the tibiofemoral joint, pain more than 30 mm based on the Visual Analogue Scale, grade I and II of osteoarthritis are included in the study and patients with grade III and IV osteoarthritis are excluded.
In this study 19 patients with mild knee osteoarthritis in the patients group and 19 healthy subjects as the control group are recruited. Each participant is evaluated in three conditions as the following: 1. Barefoot, 2. Participant's own shoes, 3. Lateral wedge insole embedded in the participant's shoes.
Each participant put on the lateral wedge insole embedded in participants' shoes for 20 minutes for adaptation. In addition, the patients in knee osteoarthritis group use the lateral wedge insole in their own shoes for 5 to 10 hours in a day for one month and will be reexamined as the follow-up. For gait initiation evaluation, each participant stands on a single force plate and will take the forward first step by examiner commend. Displacement and speed of center of pressure in three aforementioned conditions are recorded and measured as the main outcome measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060628310N1
Registration date:2016-08-14, 1395/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-14, 1395/05/24
Registrant information
Name
Mohammad Ali Sanjari
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051 ext. 198
Email address
sanjarima@alum.sharif.edu
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Iran University of Medical Sciences
Expected recruitment start date
2015-12-15, 1394/09/24
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Lateral Wedge Insole on Gait Initiation in Osteoarthritis of the Tibiofemoral Knee Joint
Public title
The effect of lateral wedge insole on initiation of walking in Arthrosis of the knee joint
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Osteoarthritis of the medical compartemnt of the tibiofemoral joint based on the American College of Rheumatology (ACR) criteria; pain more than 30 mm based on the Visual Analogue Scale (VAS); grade I and II of osteoarthritis based on the Kellgrene and Lawrence System (K&L)
Exclusion Criteria: Isolated osteoarthritis of the patellofemoral joint; grade III and IV osteoarthritis; knee surgery; progressive depression syndrome; massage therapy; physical therapy; knee injection in the last month before participation in the study; change in analgesic medication in the last previous 24 hours; knee ligament injuries; knee alignment reconstruction; age younger then 35 years old or older than 65 years old; BMI more than 30 kg/m2; foot problems which prohibited use of lateral wedge insole, including, hallux valgus, foot pronation, flat foot, etc; visual and hearing problems
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
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
Iran University of Medical Sciences
Street address
School of Rehabilitation Sciences, Madadkaran Ave., Shahnazari St., Madar Sq., Mirdamad Blvd.
City
Tehran
Postal code
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.IUMS.REC.1394.9211503210
Health conditions studied
1
Description of health condition studied
Mild Knee Osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Duration of Anticipatory postural adjustment
Timepoint
pre and 1 month after the intervention
Method of measurement
based on ms by single force plate
2
Description
Duration of monopedal phase
Timepoint
pre and 1 month after the intervention
Method of measurement
based on ms by single force plate
3
Description
Duration of bipedal phase
Timepoint
pre and 1 month after the intervention
Method of measurement
based on ms by single force plate
4
Description
Duration of APA1
Timepoint
pre and 1 month after the intervention
Method of measurement
based on ms by single force plate
5
Description
Duration of APA2
Timepoint
pre and 1 month after the intervention
Method of measurement
based on ms by single force plate
6
Description
Duration of LOC
Timepoint
pre and 1 month after the intervention
Method of measurement
based on ms by single force plate
7
Description
Velocity of COP trajectory in APA1
Timepoint
pre and 1 month after the intervention
Method of measurement
Based on m/s by single force plate
8
Description
Velocity of COP trajectory in APA2
Timepoint
pre and 1 month after the intervention
Method of measurement
Based on m/s by single force plate
9
Description
Velocity of COP trajectory in LOC
Timepoint
pre and 1 month after the intervention
Method of measurement
Based on m/s by single force plate
10
Description
Length of COP trajectory in APA1
Timepoint
pre and 1 month after the intervention
Method of measurement
based on m by single force plate
11
Description
Length of COP trajectory in APA2
Timepoint
pre and 1 month after the intervention
Method of measurement
based on m by single force plate
12
Description
Length of COP trajectory in LOC
Timepoint
pre and 1 month after the intervention
Method of measurement
based on m by single force plate
13
Description
Total Duration of gait initiation
Timepoint
pre and 1 month after the intervention
Method of measurement
based on ms by single force plate
Secondary outcomes
1
Description
Integral of anterior-posterior component of GRF in APA
Timepoint
Pre and 1 month after intervention
Method of measurement
Based on N/s by a single force plate
2
Description
Integral of anterior-posterior component of GRF in monopedal phase
Timepoint
Pre and 1 month after intervention
Method of measurement
Based on N/s by a single force plate
Intervention groups
1
Description
Lateral wedge insole which is put under shoes inner sole. At baseline, participants wear their shoes and lateral wedge insoles for 20 minutes for adaptation. The patients in knee osteoarthritis group wear the lateral wedge insoles in their own shoes for 5 to 10 hours in a day for one month and then will be evaluated for the second time as follow-up.