Osteoarthritis Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04657926 -
A Trial of APPA in the Treatment of Knee Osteoarthritis
|
Phase 2 | |
| Completed |
NCT02536833 -
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
|
Phase 2 | |
| Completed |
NCT03014037 -
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
|
N/A | |
| Recruiting |
NCT05937542 -
A Qualitative Investigation of CLEAT Participants
|
||
| Completed |
NCT03644615 -
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
|
N/A | |
| Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
| Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
| Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT03850665 -
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
|
N/A | |
| Completed |
NCT02826902 -
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
|
N/A | |
| Completed |
NCT04402502 -
Dynamic 4DCT to Examine Wrist Carpal Mechanics
|
N/A | |
| Completed |
NCT02923700 -
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
|
Phase 4 | |
| Completed |
NCT04564053 -
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
|
Phase 1 | |
| Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
| Not yet recruiting |
NCT05036174 -
Diphenhydramine Ointment for Knee Osteoarthritis
|
N/A | |
| Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
| Recruiting |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
| Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
| Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A | |
| Withdrawn |
NCT02921594 -
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
|
N/A |