NCT01412814

Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to discover the biomechanics of gait pattern adaptation in patients after a total knee replacement. 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

This study is a randomized prospective controlled study of patients after total knee arthroplasty. Patients will be recruited to the study and divided randomly into an experimental and control group. Both groups will match in terms of gender, age, pathology and clinical assessment. In addition to the intervention of the present study, all patients, whether in the experimental or control group, will carry out the usual physical therapy exercises for total knee arthroplasty as directed by their physician. The patients will be recruited and evaluated prior to surgery and for a follow-up period after surgery. 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

• Knee Arthroplasty
• Knee Arthritis Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Musculoskeletal Diseases

Interventions

Type	Name	Description
DEVICE	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.
OTHER	Physical Therapy Program	Their therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe).

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2011-08-09
• Last updated: 2015-12-22

Locations

1 site across 1 country: Israel