Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty
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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 |
- 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.
- 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.
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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 |
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| Contact: Eytan Debbi | +972-4-8292087 | edebbi@technion.ac.il |
| Contact: Alon Wolf | +972-4-8292087 | alonw@technion.ac.il |
| 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 | |
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:
|
Arthritis Musculoskeletal Diseases Osteoarthritis |
Osteoarthritis, Knee Joint Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013