Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01412814
First received: July 20, 2011
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Knee Arthroplasty
Knee Arthritis Osteoarthritis
Osteoarthritis
Osteoarthritis, Knee
Musculoskeletal Diseases
Device: AposTherapy Biomechanical System
Other: Physical Therapy Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Change from Baseline in Gait Patterns at 6-8 weeks, 5 months and 11 months [ Time Frame: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5 months and 11 months after surgery ] [ Designated as safety issue: No ]

    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 months and 11 months [ Time Frame: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5 months and 11 months after surgery ] [ Designated as safety issue: No ]
    Includes self-evaluation questionnaires


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

Detailed Description:

This study is a randomized prospective controlled study of patients after total knee arthroplasty. A total of 60 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 experimental group will be made up of 30 patients. The patients will be recruited and evaluated prior to surgery and for a follow-up period after surgery. After surgery, patients in this 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 control group will include 30 patients. The patients will be recruited and evaluated prior to surgery and for a follow-up period after surgery. The patients 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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412814

Contacts
Contact: Eytan Debbi +972-4-8292087 edebbi@technion.ac.il
Contact: Alon Wolf +972-4-8292087 alonw@technion.ac.il

Locations
Israel
Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology Recruiting
Haifa, Israel
Contact: Eytan Debbi    +972-4-8292087    edebbi@technion.ac.il   
Sub-Investigator: Eytan Debbi         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01412814     History of Changes
Other Study ID Numbers: TASMC 11 MS 0569-10-TLV CTIL, 0569-10-TLV
Study First Received: July 20, 2011
Last Updated: February 13, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Total knee arthroplasty
Total knee replacement
End-stage knee osteoarthritis
Gait patterns
Neuromuscular education

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Musculoskeletal Diseases
Arthritis
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014