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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00724139
First received: July 27, 2008
Last updated: July 28, 2008
Last verified: July 2008
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00724139     History of Changes
Other Study ID Numbers: protocol # 078
Study First Received: July 27, 2008
Last Updated: July 28, 2008
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on June 13, 2013