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

H

HaEmek Medical Center, Israel

Status

Unknown

Conditions

Knee Osteoarthritis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00724139
protocol # 078

Details and patient eligibility

About

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.

Full 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

Enrollment

15 estimated patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

1
Experimental group
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.
Treatment:
Device: : APOS biomechanical gait system, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel

Trial contacts and locations

1

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Central trial contact

Amir Haim, MD

Data sourced from clinicaltrials.gov

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