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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

NCT ID NCT07813078

NEW Sponsor: University of Rzeszow Source: ClinicalTrials.gov ↗

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Recruiting now This study
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By invitation only
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Knee osteoarthritis

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

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

    RECRUITING

    Sanok, Podkarpackie Voivodeship, 35-800, Poland

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