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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Diseases; Osteoarthritis; Osteoarthritis, Knee; Knee Arthroplasty; Knee Arthritis Osteoarthritis
• Intervention / Treatment: Device: AposTherapy Biomechanical System; Other: Physical Therapy Program

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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).	Other: Physical Therapy Program; Their therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Gait Patterns at 6-8 weeks, 5-6 months and 11-12 months	Three-dimensional gait analysis of spatiotemporal, kinetic and kinematic parameters. Surface electromyographic analysis of muscle activation patterns. Center of pressure measurements and function tests.	An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Pain, Function and Quality of Life Assessments at 6-8 weeks, 5-6 months and 11-12 months	Includes self-evaluation questionnaires	An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: August 7, 2011
• First Posted (Estimate): August 9, 2011

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Total knee replacement; Total knee arthroplasty; End-stage knee osteoarthritis; Gait patterns; Neuromuscular education
• Additional Relevant MeSH Terms: Joint Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Musculoskeletal Diseases
• Other Study ID Numbers: TASMC 11 MS 0569-10-TLV CTIL; 0569-10-TLV (Registry Identifier: Institutional Review Board Sourasky Medical Center)