Knee OsteoarthritisNCT07813078
Anti-Gravity Treadmill Gait Training for Knee Osteoarthritis
A study testing Conventional Physiotherapy and R-Force Anti-Gravity Treadmill Training in people with Knee Osteoarthritis, run by University of Rzeszow at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Conventional Physiotherapy and R-Force Anti-Gravity Treadmill Training
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 5 Jan 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Centrum Rehabilitacji niemowląt, dzieci i dorosłych SensoReh Karolina Banaś - Pastyrzak,
Sanok, Podkarpackie Voivodeship, 35-800
Piotr Pastyrzak, MSc, 531-078-080, piotr.pastyrzak@gmail.com
About this study
Official title: 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
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
- Being tested
- Conventional Physiotherapy, R-Force Anti-Gravity Treadmill Training
- Keywords
- Knee Osteoarthritis, Body-Weight-Supported Treadmill Training, Physiotherapy, Gait Re-education
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyProcedure or surgery
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.
R-Force Anti-Gravity Treadmill TrainingDevice
Gait re-education and body-weight-supported treadmill training using the R-Force anti-gravity treadmill to reduce joint loading during exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Secondary outcomes (6)
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"
Measured: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
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.
Measured: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
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.
Measured: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
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
Measured: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Pressure Pain Threshold (PPT)
Change from baseline in pressure pain threshold at standardized periarticular sites around the knee, measured in kilograms per square centimeter (kg/cm2) using a digital pressure algometer.
Measured: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Ultrasound Assessment of Periarticular Structures
Change from baseline in structural features of periarticular tissues (such as joint effusion volume, synovial thickness, or tendon presentation) evaluated qualitatively and quantitatively via knee ultrasonography
Measured: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start5 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Pastyrzak, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813078
- Sponsor's protocol ID
- Resolution No. 4/12/2025/W
- Status last verified
- May 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to institutional data protection regulations, patient privacy restrictions, and the scope of the doctoral research project. Aggregate data and study findings will be disseminated exclusively through peer-reviewed scientific publications and conference presentations
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07813078
- Acronym / sponsor ID
- Resolution No. 4/12/2025/W
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Body-Weight-Supported Treadmill Training, Physiotherapy, Gait Re-education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Conventional Physiotherapy, Device: R-Force Anti-Gravity Treadmill TrainingPatients 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. |
| Control Group | Active comparator | Procedure: Conventional PhysiotherapyPatients in this group will undergo a standard 4- week conventional physiotherapy program, 3 times a week. Each therapy session will last approximately 90 minutes. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional PhysiotherapyA 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. | Procedure or surgery | Control Group, Experimental Group |
| R-Force Anti-Gravity Treadmill TrainingGait re-education and body-weight-supported treadmill training using the R-Force anti-gravity treadmill to reduce joint loading during exercise. | Device | Experimental Group |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 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
Time frame: 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.
6 secondary outcomes
Subjective Pain Assessment using Visual Analog Scale (VAS)
Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Functional Walking Capacity via 6-Minute Walk Test (6MWT)
Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Mobility and Balance via Timed Up and Go (TUG) Test
Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Knee Joint Range of Motion (ROM)
Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Pressure Pain Threshold (PPT)
Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Ultrasound Assessment of Periarticular Structures
Time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to institutional data protection regulations, patient privacy restrictions, and the scope of the doctoral research project. Aggregate data and study findings will be disseminated exclusively through peer-reviewed scientific publications and conference presentations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy and R-Force Anti-Gravity Treadmill Training in people with Knee Osteoarthritis, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Pastyrzak, MSc (531-078-080, piotr.pastyrzak@gmail.com,), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Baseline (before intervention), 4 weeks (immediately post-intervention), and 8 weeks (follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.