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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Conventional Physiotherapy (Procedure)
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.
干预措施: R-Force Anti-Gravity Treadmill Training (Device)
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.
干预措施: Conventional Physiotherapy (Procedure)
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 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
时间窗: 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.
次要结局
- Subjective Pain Assessment using Visual Analog Scale (VAS)(Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up))
- Functional Walking Capacity via 6-Minute Walk Test (6MWT)(Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up))
- Mobility and Balance via Timed Up and Go (TUG) Test(Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up))
- Knee Joint Range of Motion (ROM)(Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up))
- Pressure Pain Threshold (PPT)(Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up))
- Ultrasound Assessment of Periarticular Structures(Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up))
研究者
Piotr Pastyrzak
MSc
University of Rzeszow