Skip to main content
OpenTrials
Completed

NCT Number: NCT01412814

Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Arthroplasty Arthritis Joint Diseases Knee Arthritis Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for first total knee arthroplasty due to end-stage knee osteoarthritis
  • Ambulatory and active patients that can participate in gait analysis

Exclusion criteria

  • Prior joint surgery of either lower extremity, with the exception of arthroscopy
  • 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

Treatment and study plan

AposTherapy Biomechanical System

Device

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

Other

Their therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe).

Primary outcomes

  1. Change from Baseline in Gait Patterns at 6-8 weeks, 5-6 months and 11-12 months

    Time frame: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery

    Three-dimensional gait analysis of spatiotemporal, kinetic and kinematic parameters.

    Surface electromyographic analysis of muscle activation patterns. Center of pressure measurements and function tests.

Secondary outcomes

  1. Change from Baseline in Pain, Function and Quality of Life Assessments at 6-8 weeks, 5-6 months and 11-12 months

    Time frame: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery

    Includes self-evaluation questionnaires

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 9, 2011
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.