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NCT Number: NCT07424352

Knee Osteoarthritis Rehabilitation Through Rotational Inertia

This study is testing whether a new type of exercise program, called eccentric overload training using a flywheel device, can improve stair-climbing ability in people with knee osteoarthritis. The flywheel device provides resistance throughout the entire movement and gives extra challenge during the muscle-lengthening phase of exercise. This type of training may improve muscle structure, strength, and coordination more effectively than conventional methods.

The study's central idea is that better muscle quality and improved coordination will lead to smoother, safer stair movement and reduce the risk of falls. Advanced tools such as ultrasound imaging and motion analysis will be used to measure muscle health and movement patterns in detail.

The hypothesis is that individuals with knee osteoarthritis have poorer muscle quality and less coordinated stair-stepping compared to healthy adults, and that performing eccentric overload training will enhance muscle quality, improve movement coordination, and make stair navigation safer and more efficient.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Katie Boncella

CONTACT

[email protected]

720-724-1786

Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Osteoarthritis (OA) Group:

  • Aged 40-70 years
  • Radiographically confirmed knee OA (Kellgren-Lawrence [KL] Grade 2 or 3)
  • Able to walk independently (assistive devices permitted)

Inclusion criteria

Healthy Control Group:

  • Aged 40-70 years
  • No radiographic evidence of knee OA (KL Grade 0 or 1)
  • No frequent knee pain
  • No history of:
  • Knee surgery (e.g., ACL reconstruction, meniscectomy, patellar realignment)
  • Significant knee injury (e.g., ligament tears, fractures, dislocations)
  • Diagnosed knee conditions (e.g., patellofemoral pain syndrome, bursitis)

Exclusion criteria

  • Uncontrolled hypertension or other cardiovascular disease
  • A musculoskeletal condition preventing physical testing
  • Neurological muscle weakness (e.g., stroke, spinal cord injury)
  • BMI >34.9 kg/m²
  • Recent hospitalization (past 3 months)

Treatment and study plan

Eccentric resistance training

Other

The intervention consists of an eccentric overload resistance training program using a portable flywheel exercise device (kBox). This device generates resistance through inertia, meaning that the load is created by the individual's own movement speed and the effort applied. Participants with knee osteoarthritis will train with the flywheel system for 8 weeks, completing two to three sessions each week, with each session lasting approximately 30 to 45 minutes. The program will focus on functional lower-limb exercises such as squats, step-ups, and knee extensions. These exercises are chosen because they closely mimic everyday movements like climbing and descending stairs. Participants randomized to the delayed-exercise subgroup will continue with usual activity and medical care for the first 8 weeks, serving as a comparison group. After this waiting period, the delayed group will then be offered the same flywheel training protocol.

Primary outcomes

  1. Stair-stepping smoothness

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Stair-stepping smoothness quantifies motor coordination during the step-up-and-over test by analyzing the fluidity and consistency of limb movements while ascending and descending stairs. It is calculated using a jerk-based smoothness metric adapted from Gonzales et al., where jerk is defined as the third derivative of the position trajectory with respect to time. The smoothness index is derived by numerically differentiating the position data x(t) obtained from motion capture three times to calculate jerk, then squaring and summing these jerk values over the duration of the movement. Lower values of the smoothness index indicate smoother, more coordinated movements. Differences in this metric will be compared between knee osteoarthritis patients and age-matched healthy controls, with variance explained through linear regression models, and between exercise intervention and delayed exercise subgroups to assess changes in motor control during stair negotiation. Unitless.

Secondary outcomes

  1. Stepping smoothness symmetry index

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Bilateral differences in smoothness during stair-step negotiation (asymmetry between limbs). Unitless.

  2. Muscle echogenicity

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Muscle echogenicity is measured via diagnostic ultrasound, which quantifies the brightness intensity (greyscale pixel values) of muscle tissue images to provide a non-invasive assessment of muscle composition and quality. Unitless.

  3. Muscle thickness

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Muscle thickness is a non-invasive ultrasound measure obtained as the distance between superficial and deep muscle borders. Units: mm.

  4. Muscle texture analysis (gray-level co-occurrence matrix)

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Muscle texture analysis using gray-level co-occurrence matrix (GLCM) is an advanced ultrasound imaging technique that quantitatively assesses the spatial distribution and relationship of pixel intensities within a muscle. Unitless.

  5. Grip strength

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Grip strength is objectively measured using a handheld dynamometer, recording the maximal isometric force over three trials. Units: kg.

  6. Lower limb strength

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Lower limb strength assessment are completed using the Biodex system involves isokinetic and isometric dynamometry to quantify maximal voluntary muscle force during knee extension and flexion. Units: Newton-meters.

  7. Timed stair ambulation

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    The Timed Stair Ambulation test measures the time taken for an individual to ascend and descend a flight of stairs, reflecting lower limb muscle power, functional mobility, and endurance. The outcome is the recorded time in seconds to complete the stair climb task, with lower times indicating better physical performance and function. Units: seconds.

  8. Short Physical Performance Battery (SPPB)

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity physical function using three timed tests: standing balance, 4-meter usual-paced walk, and five repeated chair stands. Each component is scored from 0 to 4 points, yielding a total score range from 0 to 12, where higher scores indicate better physical performance and lower disability.

  9. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a patient-reported questionnaire evaluating Osteoarthritis-related pain, stiffness, and physical function with subscale score ranges: Pain (0-20), Stiffness (0-8), and Physical Function (0-68). Higher scores indicate worse symptoms and greater disability. The total score sums all subscales, ranging from 0 to 96, with higher values representing more severe osteoarthritis impact.

  10. Joint Position

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Linear joint position measured using an optical tracking system during dynamic tasks. Unit of Measure: Meters (m)

  11. Joint Linear Velocity

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Linear joint velocity derived from optical tracking data during dynamic tasks. Unit of Measure: Meters per second (m/s)

  12. Joint Linear Acceleration

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Linear joint acceleration derived from optical tracking data during dynamic tasks.

    Unit of Measure: Meters per second squared (m/s²).

  13. Joint Angular Velocity

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Angular velocity of the joint measured during dynamic tasks using optical tracking systems. Unit of Measure: Radians per second (rad/s)

  14. Joint Angular Acceleration

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Angular acceleration of the joint measured during dynamic tasks using optical tracking systems. Unit of Measure: Radians per second squared (rad/s²).

  15. Joint Range of Motion

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Active joint range of motion measured in the sagittal, frontal, and transverse planes during dynamic tasks using optical tracking systems. Unit of Measure: Degrees (°).

  16. Joint Forces

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Net joint forces calculated using inverse dynamics during dynamic tasks. These measures reflect the mechanical loads experienced at the joint. Unit of Measure: Newtons (N).

  17. Joint Moments (Torques)

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    Net joint moments calculated using inverse dynamics during dynamic tasks. These measures reflect the rotational loads acting about the joint and provide insight into muscle performance and load distribution. Unit of Measure: Newton-meters (N·m)

  18. Self-reported pain

    Time frame: Baseline, up to 10 weeks, up to 19 weeks

    The Visual Analog Scale (VAS) is a unidimensional measure used to assess pain intensity. It consists of a 10-centimeter horizontal line with anchors at each end labeled "no pain" (0) and "worst pain imaginable" (10). Patients mark a point on the line corresponding to their pain level, which is measured in millimeters from the zero end. Higher scores indicate greater pain intensity. This scale provides a continuous range allowing sensitive detection of changes in pain over time.

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Boncella, MS

CONTACT

[email protected]

7207241786

Michael Harris-Love, PT, MPT, DSc, FGSA, FAPTA

CONTACT

[email protected]

303-724-0687

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • NIH/NCATS Colorado CTSA Grant Number T32TR004367

Registry information

Official study title

Exploring the Benefits of Eccentric Training for Aging Adults With Knee Osteoarthritis

Acronym: KORRI

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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