Robot-Aided Off-Axis Neuromuscular Training for Knee OA

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorUniversity of Maryland, Baltimore

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Robot-Aided Off-Axis Neuromuscular Training

    Device

    A 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

    Device

    traditional elliptical regular stepping

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: evaluation-based, progressive, off-axis neuromuscular training groupExperimental treatment 1 intervention
Group B: traditional elliptical regular stepping groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak knee adduction moment

Time frame
Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training
2

Knee pain

Questionnaires, including the Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time frame
Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training

Secondary outcomes

1

Knee proprioception acuity/pain in off-axis directions

Time frame
Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training
2

Knee range of motions/stiffness/laxity in off-axis directions

Time frame
Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training
3

Functional ability

Time-up-and-go test (usual and fast speed) and 6-minute walking test

Time frame
Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training
4

Heath-related quality of life

Assessed by the SF-36 questionnaire.

Time frame
Baseline, immediately after the 5-week training, and follow-up evaluation 8-week post-training

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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