Anti-Gravity Treadmill Gait Training for Knee Osteoarthritis

NCT07813078 | Recruiting

• 1 other identifier: Resolution No. 4/12/2025/W
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Body-Weight-Supported Treadmill Training; Physiotherapy; Gait Re-education

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

• 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.

  Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)

Secondary Outcomes (6)

• 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)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Procedure: Conventional Physiotherapy; Device: R-Force Anti-Gravity Treadmill Training

Control Group

ACTIVE COMPARATOR

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.

Procedure: Conventional Physiotherapy

Interventions

Conventional Physiotherapy PROCEDURE

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.

Control Group; Experimental Group

R-Force Anti-Gravity Treadmill Training DEVICE

Gait re-education and body-weight-supported treadmill training using the R-Force anti-gravity treadmill to reduce joint loading during exercise.

Experimental Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

Centrum Rehabilitacji niemowląt, dzieci i dorosłych SensoReh Karolina Banaś - Pastyrzak,

Sanok, Podkarpackie Voivodeship, 35-800, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Piotr Pastyrzak, MSc

CONTACT

531-078-080; piotr.pastyrzak@gmail.com,

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)