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Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty

Primary Purpose

Knee Arthroplasty, Knee Arthritis Osteoarthritis, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
AposTherapy Biomechanical System
Physical Therapy Program
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthroplasty focused on measuring Total knee arthroplasty, Total knee replacement, End-stage knee osteoarthritis, Gait patterns, Neuromuscular education

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2011
Last Updated
December 21, 2015
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01412814
Brief Title
Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty
Official Title
Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthroplasty, Knee Arthritis Osteoarthritis, Osteoarthritis, Osteoarthritis, Knee, Musculoskeletal Diseases
Keywords
Total knee arthroplasty, Total knee replacement, End-stage knee osteoarthritis, Gait patterns, Neuromuscular education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
AposTherapy Biomechanical System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy Program
Intervention Description
Their therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe).
Primary Outcome Measure Information:
Title
Change from Baseline in Gait Patterns at 6-8 weeks, 5-6 months and 11-12 months
Description
Three-dimensional gait analysis of spatiotemporal, kinetic and kinematic parameters. Surface electromyographic analysis of muscle activation patterns. Center of pressure measurements and function tests.
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
Secondary Outcome Measure Information:
Title
Change from Baseline in Pain, Function and Quality of Life Assessments at 6-8 weeks, 5-6 months and 11-12 months
Description
Includes self-evaluation questionnaires
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology
City
Haifa
Country
Israel

12. IPD Sharing Statement

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Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty

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