Anti-Gravity Treadmill Gait Training for Knee Osteoarthritis
Recruiting · NCT07813078 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Centrum Rehabilitacji niemowląt, dzieci i dorosłych SensoReh Karolina Banaś - Pastyrzak, - Sanok, Podkarpackie Voivodeship, Poland