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NCT Number: NCT07649863

The Effect of Physical Activity on Knee Osteoarthritis, Pain and Gait

Knee osteoarthritis, a chronic musculoskeletal disease, is the most prevalent type of osteoarthritis and the leading cause of disability and major healthcare costs worldwide. The pathogenesis of the disease is not fully understood and there are few non-invasive disease-modifying therapies available to patients. Therefore, there is a critical need to enhance therapeutic interventions, which requires improvement of our understanding of knee osteoarthritis pathogenesis.

Increasing evidence suggests that physical activity and exercise training are cost-effective and widely available interventions for the treatment of knee osteoarthritis, however, consideration of type of physical activity and optimal exercise modality are needed to reduce pain, improve gait, knee joint function, stiffness, and muscle weakness in individuals with knee osteoarthritis.

The aim of this pilot clinical trial is to compare individuals with knee osteoarthritis who have not exercised with individuals that have performed retro walking exercise chosen from the systematic review and survey we have conducted previously to reduce pain and improve gait.

Non-linear analyses will be performed to determine the effects of exercise intervention on gait biomechanics and stability of movement in these patients. These findings may form a basis for recommendations of exercise/physical activity interventions for the benefits of patients with knee osteoarthritis including pain reduction, mobility improvement and gait modification.

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Key information

Conditions

Osteoarthritis (OA) of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female
  • Any ethnicity
  • Adults over 18 years old
  • Meet the UK guidelines for physical activity supported by NICE (National Institute for Health and Care Excellence) and NHS (able to exercise if it is safe with regular breaks)
  • Otherwise, adults with clinically diagnosed knee osteoarthritis according to NICE criteria or confirmed by a healthcare professional able and willing to participate and provide written informed consent

Exclusion criteria

  • Any musculoskeletal injury
  • Any conditions known to affects gait (e.g. Parkinson's disease or stroke)
  • Any surgical intervention in the previous 12 months on lower limbs
  • Surgical replacement of hip or knee joints
  • BMI (body mass index) over 35
  • Athletes or take part in significant recreational activity
  • Takes any medication known to affect the gait and ability to walk
  • Received an intra-articular injection in the last 3 months
  • Have been told by medical professionals that they should not take part in any intensity exercise/physical activity

Treatment and study plan

Retro walking (backwards walking) on a treadmill

Other

Prior to the intervention participants will be made familiar with retro walking on the treadmill. The exercise will consist of a forward walking for 5min on the treadmill for warm-up followed by retro walking for 10min and a cool-down for 5min. Participants will be instructed to increase their retro walking time up to 30min if the pain sensation continuously was reduced (pain scores < 3 numerical rating scale).

The comfortable speed of the retro walking will be determined by the participant under supervision of the researchers. No slopes or inclination will be used in this study for participant safety. In the warm-up and cool-down sessions participants will be asked to perform muscle stretch, ankle toe movements and heel raise exercises.

Other names: Exercise

Primary outcomes

  1. Knee function and associated frequency and severity of pain

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Participants' opinion about their own knee function and associated problems will be assessed through self-administered and validated questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS).

    KOOS questionnaire designed to collectively evaluate and measure five outcomes in individuals with knee osteoarthritis including:

    Pain: Frequency and severity of knee pain. Symptoms: Swelling, grinding, stiffness, and range of motion issues. Activities of Daily Living (ADL): Difficulty with physical tasks like stairs, rising from a seat, or getting in and out of a car.

    Sports and Recreation Function: The ability to perform higher-level physical activities, such as running, squatting, or playing sports.

    Quality of Life (QOL): Knee-related lifestyle limitations and personal awareness of the joint.

Secondary outcomes

  1. Pain intensity

    Time frame: Baseline or Day 1 up to 6 weeks

    A standardised tool numeric pain rating scale (NPRS) will be used to measure a participants' pain intensity. It is an 11-point scale ranging from 0 to 10.

    0: Represents "no pain" whereas 10: Represents the "worst imaginable pain". Participants can state their number verbally or circle it on a chart.

  2. The gait biomechanics - change from baseline in spatiotemporal parameter walking speed at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Spatiotemporal parameter walking speed (velocity, meters/sec) will be assessed using VICON motion capture analysis system.

  3. The gait biomechanics - change from baseline in spatiotemporal parameter cadence at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Spatiotemporal parameter cadence (steps/min) will be assessed using VICON motion capture analysis system.

  4. The gait biomechanics - change from baseline in spatiotemporal parameter stride/step length at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Spatiotemporal parameter stride/step length (meters or cm) will be assessed using VICON motion capture analysis system.

  5. The gait biomechanics - change from baseline in spatiotemporal parameter swing/stance phases at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Spatiotemporal parameter swing/stance phases (% of gait cycle) will be assessed using VICON motion capture analysis system.

  6. The gait biomechanics - change from baseline in spatiotemporal parameter double support time at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Spatiotemporal parameter double support time (% of gait cycle) will be assessed using VICON motion capture analysis system.

  7. The gait biomechanics - change from baseline in kinetic parameter knee adduction moment (KAM) at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Kinetic parameter knee adduction moment (KAM) (Newton meters Nm) will be assessed using VICON motion capture analysis system.

  8. The gait biomechanics - change from baseline in kinetic parameter knee flexion/extension moment at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Kinetic parameter knee flexion/extension moment (Newton meters Nm) will be assessed using VICON motion capture analysis system.

  9. The gait biomechanics - change from baseline in kinetic parameter vertical ground reaction force (vGRF) at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Kinetic parameter vertical ground reaction force (vGRF) (Newtons N) will be assessed using VICON motion capture analysis system.

  10. The gait biomechanics - change from baseline in kinetic parameter joint contact force (JCF) at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Kinetic parameter joint contact force (JCF) (Newtons N) will be assessed using VICON motion capture analysis system.

  11. The gait biomechanics - change from baseline in kinematic parameter knee flexion angle at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Kinematic parameter knee flexion angle (Degrees (°)) will be assessed using VICON motion capture analysis system.

  12. The gait biomechanics - change from baseline in kinematic parameter Range of Motion (ROM) at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Kinematic parameter Range of Motion (ROM) (Degrees (°)) will be assessed using VICON motion capture analysis system.

  13. The gait biomechanics - change from baseline in kinematic parameter knee adduction/abduction at 6 weeks

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    Kinematic parameter knee adduction/abduction (Degrees (°)) will be assessed using VICON motion capture analysis system.

  14. Gait stability

    Time frame: Baseline or Day 1 and end of study at 6 weeks

    The stability of walking will be measured using non-linear analysis including Lyapunov (1/s or s^(-1)) and Hurst Exponents.

Study contacts

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

Hasmik J Samvelyan, PhD

CONTACT

[email protected]

+441245683738

Nathan Bytheway, MEng

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Anglia Ruskin University

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • Nuffield Health

Registry information

Official study title

The Effect of Retro Walking on Pain and Gait Biomechanics Using Non-linear Analysis in People With Knee Osteoarthritis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2026
Registry last updated
Jun 16, 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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