Anti-Gravity Treadmill Gait Training for Knee Osteoarthritis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Conventional Physiotherapy; Device: R-Force Anti-Gravity Treadmill Training

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Piotr Pastyrzak, MSc; Phone Number: 531-078-080; Email: piotr.pastyrzak@gmail.com,

Study Locations

• Poland
  • Podkarpackie Voivodeship
    • Sanok, Podkarpackie Voivodeship, Poland, 35-800
      • Recruiting
      • Centrum Rehabilitacji niemowląt, dzieci i dorosłych SensoReh Karolina Banaś - Pastyrzak,
      • Contact: Piotr Pastyrzak, MSc; Phone Number: 531-078-080; Email: piotr.pastyrzak@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Patients in this group will receive a comprehensive 4-week therapeutic program, 3 times a week. The intervention combines conventional physiotherapy with gait re-education and training on the R-Force bodyweight- supported anti-gravity treadmill. Each therapy session will last approximately 90 minutes.	Procedure: Conventional Physiotherapy; 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.; Device: R-Force Anti-Gravity Treadmill Training; Gait re-education and body-weight-supported treadmill training using the R-Force anti-gravity treadmill to reduce joint loading during exercise.
Active Comparator: Control Group; Patients in this group will undergo a standard 4- week conventional physiotherapy program, 3 times a week. Each therapy session will last approximately 90 minutes.	Procedure: Conventional Physiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)	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.	Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Gait Parameters - Stride Length	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.	Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Pain Assessment using Visual Analog Scale (VAS)	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"	Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Functional Walking Capacity via 6-Minute Walk Test (6MWT)	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.	Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Mobility and Balance via Timed Up and Go (TUG) Test	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.	Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Knee Joint Range of Motion (ROM)	Change from baseline in active and passive knee joint flexion and extension angles, measured in degrees using a standard universal goniometer	Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Pressure Pain Threshold (PPT)	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.	Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Ultrasound Assessment of Periarticular Structures	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	Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

Collaborators and Investigators

• Sponsor: University of Rzeszow

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 4, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Physiotherapy; Knee Osteoarthritis; Body-Weight-Supported Treadmill Training; Gait Re-education
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Resolution No. 4/12/2025/W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available due to institutional data protection regulations, patient privacy restrictions, and the scope of the doctoral research project. Aggregate data and study findings will be disseminated exclusively through peer-reviewed scientific publications and conference presentations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No