Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty
NCT ID: NCT01412814
Last Updated: 2015-12-22
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-07-31
2014-12-31
Brief Summary
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The first hypothesis of the project was that center-of-pressure manipulation at the foot during dynamic loading is capable of changing the forces, torques and muscle activation patterns of the lower limb.
The second hypothesis of the project was that patient-specific center-of-pressure manipulation at the foot combined with repetitive perturbation training over time will improve neuromuscular function, barefoot gait patterns, muscle activation patterns, pain, quality of life and energy consumption in patients after a total knee replacement.
Detailed Description
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After surgery, patients in the experimental group will be fitted with a customized biomechanical device worn on the feet (Apos System, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel). The device is calibrated personally to each patient. By calibrating the device, the center-of-pressure of the foot can be manipulated during all phases of the gait cycle. The device is capable of inducing controlled perturbation during gait. The immediate effects of the device will be evaluated using center-of-pressure measurements, three-dimensional gait analyses and surface electromyography. The patients are instructed to walk with the device according to a therapy protocol (AposTherapy). Patients will be evaluated for changes in gait via three-dimensional gait analyses, muscle activation pattern changes via surface electromyography, pain, quality of life and energy consumption.
The patients in the control group will carry out the same walking exercises as the experimental group, but without the biomechanical intervention device (placebo walking shoe). The patients will be evaluated with the same tools over time as with the experimental group.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental
These patients will carry out the specified intervention of the study with the AposTherapy Biomechanical System in addition to the typical physical therapy regiment prescribed to them by their physician.
AposTherapy Biomechanical System
The device is comprised of four adjustable modular elements attached to foot-worn platforms that are capable of manipulating the foot's center-of-pressure and applying perturbation training throughout the gait cycle. The device allows for neuromuscular training during dynamic loading.
Control
The patients within this group will also carry out the typical physical therapy program for total knee replacement as prescribed by their physician. The patients will carry out a similar therapy program to the experimental group, but without the study intervention device (placebo walking shoe).
Physical Therapy Program
Their therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe).
Interventions
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AposTherapy Biomechanical System
The device is comprised of four adjustable modular elements attached to foot-worn platforms that are capable of manipulating the foot's center-of-pressure and applying perturbation training throughout the gait cycle. The device allows for neuromuscular training during dynamic loading.
Physical Therapy Program
Their therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe).
Eligibility Criteria
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Inclusion Criteria
* Ambulatory and active patients that can participate in gait analysis
Exclusion Criteria
* Unsteady gait
* Back pain
* Neurological, pulmonary or cardiovascular pathologies or risks that may affect long-term performance
* Inability to understand or comply with the treatment protocol
40 Years
90 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Locations
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Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology
Haifa, Israel, Israel
Countries
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Other Identifiers
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0569-10-TLV
Identifier Type: REGISTRY
Identifier Source: secondary_id
TASMC 11 MS 0569-10-TLV CTIL
Identifier Type: -
Identifier Source: org_study_id