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NCT Number: NCT07813078

Anti-Gravity Treadmill Gait Training for Knee Osteoarthritis

Purpose: The aim of the study will be to evaluate the effectiveness of traditional physiotherapy supported by gait re-education using the R-Force bodyweight-supported treadmill in improving gait parameters, range of motion, knee joint function, quality of life, and body composition in patients with knee osteoarthritis. The study will be conducted in the form of a prospective, randomized clinical trial with participants divided into two therapeutic groups: a control group and an experimental group. The therapeutic program will last 4 weeks and will be implemented 3 times a week. Changes in gait parameters, range of motion, knee joint function, quality of life, and body composition will be evaluated.Material: The study will include patients ≥ 40 years of age with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3), confirmed radiologically, reporting pain lasting ≥ 3 months. Participants (n = 80) will be randomly assigned to the control group (conventional physiotherapy) or the experimental group (conventional physiotherapy + training on the R-Force treadmill).Methods: Participants will be assessed at three time points: before the intervention (baseline), after completing the 4-week therapeutic program (postintervention), and after 8 weeks (follow-up). The methods used will include: analysis of gait parameters on the R-Force treadmill, 6-Minute Walk Test (6MWT), Timed Up and Go (TUG) test, measurements of knee joint range of motion using a goniometer, thigh and lower leg circumference measurements, body composition analysis using the BIA method, subjective pain assessment using the Visual Analog Scale (VAS) and Laitinen scale, pressure pain threshold assessment using a digital algometer, functional assessment using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires, quality of life assessment (WHOQOL-BREF), Hospital Anxiety and Depression Scale (HADS), as well as assessment of periarticular structures using ultrasound.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centrum Rehabilitacji niemowląt, dzieci i dorosłych SensoReh Karolina Banaś - Pastyrzak,

Sanok, Podkarpackie Voivodeship, 35-800, Poland

Location status: Recruiting

Location contact

Piotr Pastyrzak, MSc

CONTACT

[email protected]

531-078-080

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Radiologically confirmed knee osteoarthritis (grade 2 or 3 according to the Kellgren-Lawrence classification).
  • General health and functional status allowing participation in the physical therapy program (based on clinical assessment).
  • Knee joint pain persisting for at least 3 months, with an intensity of >= 4 on the Visual Analog Scale (VAS).
  • Age between 40 and 70 years.
  • Ability to ambulate independently without any orthopedic assistive devices.
  • Voluntary written informed consent to participate in the study.
  • No medical contraindications to physical exercise.

Exclusion criteria

  • Knee osteoarthritis grade 4 according to the Kellgren-Lawrence classification or lack of radiological changes (grade 0-1).
  • History of total or partial knee arthroplasty (joint replacement).
  • Contraindications to body composition analysis (e.g., implanted pacemaker, electronic implants, epilepsy).
  • Knee joint instability (e.g., ligamentous injury).
  • Acute joint inflammation.
  • Neuropathies, myopathies, or other neurological conditions affecting gait.
  • Active neoplastic diseases (cancer) or advanced cardiovascular diseases.
  • Participation in other clinical trials within the last 6 months.
  • Participation in another physical therapy or rehabilitation program within the last 6 months.
  • Planned intra-articular injections or injections received in the affected knee joint within the last 3 months.
  • Regular use of analgesic or anti-inflammatory drugs (NSAIDs, corticosteroids) at doses that could affect the assessment of pain and function.

Treatment and study plan

Conventional physiotherapy

Procedure

A standard program consisting of targeted physical exercises, range of motion improvements, and strength conditioning for patients with knee osteoarthritis. Traditional physiotherapy will include isometric exercises, strengthening, stretching, balance exercises (with elements of proprioception training), active non-weight-bearing exercises, functional exercises, gait exercises, as well as breathing and relaxation exercises.

R-Force Anti-Gravity Treadmill Training

Device

Gait re-education and body-weight-supported treadmill training using the R-Force anti-gravity treadmill to reduce joint loading during exercise.

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

    Change from baseline in knee joint function and symptoms using the KOOS questionnaire. The questionnaire assesses 5 subscales: Pain, Symptoms, Activities of Daily Living, Sport and Recreation Function, and Knee-related Quality of Life. Scores range from 0 to 100, where 100 indicates no symptoms and 0 indicates extreme symptoms.

  2. Gait Parameters - Stride Length

    Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

    Change from baseline in mean stride length (measured in centimeters) during treadmill walking, evaluated using the built-in spatio-temporal analysis system of the R-Force treadmill.

Secondary outcomes

  1. Subjective Pain Assessment using Visual Analog Scale (VAS)

    Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

    Change from baseline in self-reported knee pain intensity during movement using a 100 mm Visual Analog Scale, where 0 mm represents "no pain" and 100 mm represents "worst imaginable pain"

  2. Functional Walking Capacity via 6-Minute Walk Test (6MWT)

    Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

    Change from baseline in the maximum distance (measured in meters) that a participant can walk quickly on a flat, hard surface in a period of 6 minutes.

  3. Mobility and Balance via Timed Up and Go (TUG) Test

    Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

    Change from baseline in the time (measured in seconds) taken by a participant to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down.

  4. Knee Joint Range of Motion (ROM)

    Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

    Change from baseline in active and passive knee joint flexion and extension angles, measured in degrees using a standard universal goniometer

  5. Pressure Pain Threshold (PPT)

    Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

    Change from baseline in pressure pain threshold at standardized periarticular sites around the knee, measured in kilograms per square centimeter (kg/cm2) using a digital pressure algometer.

  6. Ultrasound Assessment of Periarticular Structures

    Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

    Change from baseline in structural features of periarticular tissues (such as joint effusion volume, synovial thickness, or tendon presentation) evaluated qualitatively and quantitatively via knee ultrasonography

Study contacts

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

Piotr Pastyrzak, MSc

CONTACT

[email protected],

531-078-080

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Registry information

Official study title

Evaluation of the Effectiveness of Traditional Physiotherapy Supported by Gait Re-education Using the R-Force Anti-Gravity Treadmill in Patients With Knee Osteoarthritis - Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

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

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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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