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Anti-Gravity Treadmill Gait Training for Knee Osteoarthritis

4 september 2026 bijgewerkt door: Piotr Pastyrzak, University of Rzeszow

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Polen
    • Podkarpackie Voivodeship
      • Sanok, Podkarpackie Voivodeship, Polen, 35-800
        • Werving
        • Centrum Rehabilitacji niemowląt, dzieci i dorosłych SensoReh Karolina Banaś - Pastyrzak,
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Tijdsspanne: 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.
Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Gait Parameters - Stride Length
Tijdsspanne: 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.
Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Subjective Pain Assessment using Visual Analog Scale (VAS)
Tijdsspanne: 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"
Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Functional Walking Capacity via 6-Minute Walk Test (6MWT)
Tijdsspanne: 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.
Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Mobility and Balance via Timed Up and Go (TUG) Test
Tijdsspanne: 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.
Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Knee Joint Range of Motion (ROM)
Tijdsspanne: 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
Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Pressure Pain Threshold (PPT)
Tijdsspanne: 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.
Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Ultrasound Assessment of Periarticular Structures
Tijdsspanne: 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
Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Rzeszow

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 januari 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

4 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 september 2026

Eerst geplaatst (Werkelijk)

10 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

4 september 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Resolution No. 4/12/2025/W

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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