About this trial
Although the primary knee motion occurs in flexion/extension, the frontal and transverse (off-axis) knee motions are smaller but crucial for maintaining joint stability and normal knee loading. Altered kinematics and neuromuscular control in off-axis knee motions have been reported in patients with knee osteoarthritis (OA), which are associated with excessive knee loading and the progression of knee OA. However, traditional rehabilitative treatments for people with knee OA and existing exercise equipment often focus on sagittal plane movement. Probably due to the technical limitations, there is a lack of convenient and effective equipment/method to train patients with knee OA in off-axis (frontal and transverse) planes.
The purpose of this study is to use a robot-aided elliptical training device to measure knee neuromechanical properties and to improve neuromuscular control in off-axis knee motions, aiming for joint de-loading and pain reduction for individuals with knee OA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 45 - 85 years.
Meets the ACR classification criteria for knee OA (clinical + radiographic criteria); Kellgren-Lawrence grade I-III.
Persistent knee pain ≥ 3 months.
Able to independently complete elliptical training (6 minutes without interruption).
Disqualifiers
Other inflammatory joint diseases (e.g., rheumatoid arthritis).
Knee trauma, surgery, or intra-articular injections within the past year.
History of knee or hip replacement.
Cardiovascular disease or uncontrolled hypertension contradict to exercises.
Trial design
Parallel
Treatments tested in this trial
Robot-Aided Off-Axis Neuromuscular Training
DeviceA novel custom-designed elliptical trainer is developed, and its footplates are robot-controlled to be moved in four off-axis directions (sliding in/out, pivoting in/out; corresponding to knee valgus/varus, internal rotation/external rotation). Before the training, off-axis neuromechanical assessments will be conducted to determine which specific off-axis direction (valgus, varus, internal rotation, external rotation, or combination of the off-axis directions) has neuromechanical deficits. During the evaluation-based and subject-specific neuromuscular training, the different training modes will be conducted progressively from regular stepping, footplate position control, spring mode, perturbation, to slippery mode.
Traditional elliptical regular stepping
Devicetraditional elliptical regular stepping
Treatment groups
Trial outcomes
Primary outcomes
Peak knee adduction moment
Knee pain
Questionnaires, including the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Secondary outcomes
Knee proprioception acuity/pain in off-axis directions
Knee range of motions/stiffness/laxity in off-axis directions
Functional ability
Time-up-and-go test (usual and fast speed) and 6-minute walking test
Heath-related quality of life
Assessed by the SF-36 questionnaire.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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