The Effect of Training With Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Knee Osteoarthritis Patients
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
: APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria:
- Community-dwelling older adults.
- Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren & Lawrence scale.
- Ambulatory and active patients that can precipitate the gait analysis.
- Age 50-75.
- No prior joint replacement in the lower extremity.
Exclusion Criteria:
Exclusion Criteria:
- Knee pain due to pathologic conditions other than OA, such as rheumatoid arthritis and pseudogout.
- Knee with flexion contracture greater than 20°.
- Patients with hip problems, symptomatic lumbar spine disease, spinal cord.
- Ataxic gait related to neurologic disease.
- Patients with increased tendency to fall.
- Lack of physical or mental ability to perform or comply with the treatment procedure.
- Diabetes mellitus.
- History of pathological osteoporotic fracture.
Sites / Locations
- Technion Israel institute of technologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
patients (aged 50-75) with Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren & Lawrence scale.
Outcomes
Primary Outcome Measures
footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain
Secondary Outcome Measures
would repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning
Full Information
NCT ID
NCT00724139
First Posted
July 27, 2008
Last Updated
July 28, 2008
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00724139
Brief Title
The Effect of Training With Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Knee Osteoarthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
5. Study Description
Brief Summary
The aim of this study is to evaluate the outcome of specific repetitive biomechanical perturbation training on motor patterns.
The first hypothesis of this project is that footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain.
The second hypothesis of the project is that repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning thus conveying plasticity of existing locomotor patterns and gait strategies.
Detailed Description
Design: Prospective, case control Setting: subjects will undergo a tailored training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms (APOS system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel) which conveys perturbation throughout the gait sickle. Pre and post training level walking will be examined via: (1) a three-dimensional motion analysis system and (2) ground reaction force analysis using force platforms (3) Electro-Myography system. Each subject will be examined in 4 different settings Patients will then participate in continued biomechanical perturbation training for 3-6 month and will then undergo a second gait examination Ages Eligible for Study: 50 Years - 75 Years, Genders Eligible for Study: None Accepts patients suffering from medial compartment knee osteoarthritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
patients (aged 50-75) with Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren & Lawrence scale.
Intervention Type
Device
Intervention Name(s)
: APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel
Intervention Description
training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms which conveys perturbation throughout the gait cycle
Primary Outcome Measure Information:
Title
footwear derived biomechanical challenges will convey active and passive matching biomechanical responses (i.e. kinetic, kinematic and electromyographic) trough out the musculoskeletal kinematic chain
Time Frame
6 months
Secondary Outcome Measure Information:
Title
would repetitive exposure to in-situ (trough out the gait sickle) introduction to a biomechanical stimulus would generate a process of motor learning
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria:
Community-dwelling older adults.
Symptomatic knee OA for at least 6 months, fulfilled American College of Rheumatology clinical criteria for OA of the knee and radiographically assessed osteoarthritis of the knee graded 1-2 according to the Kellgren & Lawrence scale.
Ambulatory and active patients that can precipitate the gait analysis.
Age 50-75.
No prior joint replacement in the lower extremity.
Exclusion Criteria:
Exclusion Criteria:
Knee pain due to pathologic conditions other than OA, such as rheumatoid arthritis and pseudogout.
Knee with flexion contracture greater than 20°.
Patients with hip problems, symptomatic lumbar spine disease, spinal cord.
Ataxic gait related to neurologic disease.
Patients with increased tendency to fall.
Lack of physical or mental ability to perform or comply with the treatment procedure.
Diabetes mellitus.
History of pathological osteoporotic fracture.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Haim, MD
Phone
0524262129
Email
amirhaim@gmail.com
Facility Information:
Facility Name
Technion Israel institute of technology
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Haim, MD
Phone
0524262129
Email
amirhaim@gmail.com
First Name & Middle Initial & Last Name & Degree
Amir Haim, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
25377767
Citation
Debbi EM, Wolf A, Goryachev Y, Rozen N, Haim A. Alterations in sagittal plane knee kinetics in knee osteoarthritis using a biomechanical therapy device. Ann Biomed Eng. 2015 May;43(5):1089-97. doi: 10.1007/s10439-014-1177-3. Epub 2014 Nov 7.
Results Reference
derived
Learn more about this trial
The Effect of Training With Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Knee Osteoarthritis Patients
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