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The Effect of Training With Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Knee Osteoarthritis Patients

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ClinicalTrials.gov Identifier: NCT00724139
Recruitment Status : Unknown
Verified July 2008 by HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
First Posted : July 29, 2008
Last Update Posted : July 29, 2008
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

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.


Condition or disease Intervention/treatment
Knee Osteoarthritis Device: : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2008
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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.
Device: : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel
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 Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria:

    1. Community-dwelling older adults.
    2. 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.
    3. Ambulatory and active patients that can precipitate the gait analysis.
    4. Age 50-75.
    5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724139


Contacts
Contact: Amir Haim, MD 0524262129 amirhaim@gmail.com

Locations
Israel
Technion Israel institute of technology Recruiting
Haifa, Israel
Contact: Amir Haim, MD    0524262129    amirhaim@gmail.com   
Sub-Investigator: Amir Haim, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00724139     History of Changes
Other Study ID Numbers: protocol # 078
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: July 29, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases