An interventional study of Conventional Physiotherapy and R-Force Anti-Gravity Treadmill Training in Knee Osteoarthritis, sponsored by University of Rzeszow. Recruiting at 1 site in Poland. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University of Rzeszow · Not applicable, Interventional, and Treatment
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 80 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Rzeszow is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Device: R-Force Anti-Gravity Treadmill Training
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.
Gait re-education and body-weight-supported treadmill training using the R-Force anti-gravity treadmill to reduce joint loading during exercise.
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.
Time frame: 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.
Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
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"
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Plan to share: No — 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
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 11 months is below that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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University of Rzeszow