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Anti-Gravity Treadmill Gait Training for Knee Osteoarthritis

4 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Polska
    • Podkarpackie Voivodeship
      • Sanok, Podkarpackie Voivodeship, Polska, 35-800
        • Rekrutacyjny
        • Centrum Rehabilitacji niemowląt, dzieci i dorosłych SensoReh Karolina Banaś - Pastyrzak,
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Procedura: 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.
Urządzenie: 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.
Aktywny komparator: 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.
Procedura: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Subjective Pain Assessment using Visual Analog Scale (VAS)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Rzeszow

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 stycznia 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2026

Ukończenie studiów (Szacowany)

30 czerwca 2027

Daty rejestracji na studia

Pierwszy przesłany

4 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 września 2026

Pierwszy wysłany (Rzeczywisty)

10 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 września 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Resolution No. 4/12/2025/W

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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