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

NCT ID: NCT00724139

Last Updated: 2008-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-05-31

Brief Summary

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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

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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

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

training program utilizing a novel biomechanical system comprising four modular elements attached onto foot-worn platforms which conveys perturbation throughout the gait cycle

Interventions

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: 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

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Locations

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Technion Israel institute of technology

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Amir Haim, MD

Role: CONTACT

Phone: 0524262129

Email: [email protected]

Facility Contacts

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Amir Haim, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 25377767 (View on PubMed)

Other Identifiers

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protocol # 078

Identifier Type: -

Identifier Source: org_study_id