Anti-Gravity Treadmill Gait Training for Knee Osteoarthritis
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorUniversity of Rzeszow
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Physiotherapy
Procedure/SurgeryA 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.
R-Force Anti-Gravity Treadmill Training
DeviceGait re-education and body-weight-supported treadmill training using the R-Force anti-gravity treadmill to reduce joint loading during exercise.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov