Knee Osteoarthritis
Conditions
Keywords
Knee Osteoarthritis, Body-Weight-Supported Treadmill Training, Physiotherapy, Gait Re-education
Brief summary
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.
Interventions
PROCEDUREConventional 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.
DEVICER-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.
Sponsors
University of Rzeszow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. |
| Gait Parameters - Stride Length | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjective Pain Assessment using Visual Analog Scale (VAS) | 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" |
| Functional Walking Capacity via 6-Minute Walk Test (6MWT) | 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. |
| Mobility and Balance via Timed Up and Go (TUG) Test | 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. |
| Knee Joint Range of Motion (ROM) | 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 |
| Pressure Pain Threshold (PPT) | 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. |
| Ultrasound Assessment of Periarticular Structures | 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 |
Countries
Poland
Contacts
CONTACTPiotr Pastyrzak, MSc
Outcome results
None listed