Comparison of the efficacy of an unloading knee brace equipped with vibration stimulation Vs conventional unloading knee brace on functional performance, external knee adduction moment and activitition level of lateral side of the surrounding knee muscles, in subjects with knee osteoarthritis.
Comparison of the efficacy of an unloading knee brace equipped with vibration stimulation Vs conventional unloading knee brace on functional performance, external knee adduction moment and activation level of lateral side of the surrounding knee muscles, in subjects with knee osteoarthritis.
Design
The proposed study is a clinical trial and is designed to be conducted as a Randomized Control Trial (RCT). Participants will be randomly allocated to the experimental and control groups. Baseline assessments will be performed for all the participants. Those with experimental group will be supplied with the vibratory knee orthosis and those with control group will be supplied by the conventional knee OA brace. Finally, after 6 weeks, all the participants will be re-assessed.
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
The participants in intervention group will use the unloader knee brace equipped with vibrator for 6 weeks.
The participants in control group will use the custom unloader knee brace for 6 weeks.
Comparison of the efficacy of an unloading knee brace equipped with vibration stimulation Vs conventional unloading knee brace on functional performance, external knee adduction moment and activitition level of lateral side of the surrounding knee muscles, in subjects with knee osteoarthritis.
Public title
Comparison of the efficacy of an unloading knee brace equipped with vibration stimulation Vs conventional unloading knee brace in subjects 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
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The participants of the current study will be randomly assigned in two groups of intervention and control, using simple random method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Faculty of Rehabilitation Sciences of Iran University of Medical Sciences, Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.302
2
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Faculty of Rehabilitation Sciences of Iran University of Medical Sciences, Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.302
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Unilateral primary osteoarthritis of knee
Primary outcomes
1
Description
Functional performance
Timepoint
before receiving the intervention and 6 weeks after receiving the intervention
Method of measurement
KOOS questionnaire
2
Description
Knee adduction moment
Timepoint
before receiving the intervention and 6 weeks after receiving the intervention
Method of measurement
Force plate synchronized with the motion analysis instrument
3
Description
Activation Level
Timepoint
before receiving the intervention and 6 weeks after receiving the
Method of measurement
Using electrocardiography instrument
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants in intervention group will use the unloader knee brace equipped with vibrator for 6 weeks.
Category
Rehabilitation
2
Description
Control group: The participants in control group will use the custom unloader knee brace for 6 weeks.