ArthropathyNCT07040878
Antigravity Treadmill After Joint Arthroplasty
A study testing Antigravity Treadmill Training, Body Weight-Supported Treadmill Training and Conventional rehabilitation in people with Arthropathy and Osteoarthritis, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
The study aims to evaluate the efficacy of antigravity treadmill training and body weight-supported treadmill training in the rehabilitation of elderly patients (60-75 years) following hip or knee arthroplasty. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Arthropathy, Osteoarthritis
- What is being tested?
- Antigravity Treadmill Training, Body Weight-Supported Treadmill Training and Conventional rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 15 May 2025to 30 Jun 2026
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals who have recently undergone hip or knee joint arthroplasty surgeries aged 60 years and above.
Who cannot join
- cognitive impairments that prevent independent completion of research questionnaires
- history of consciousness disturbances, psychotic disorders, bipolar disorder, or other severe psychiatric illnesses
- functional status preventing independent ambulation (wheelchair-bound or bedridden patients; orthopedic devices such as crutches or walker allowed)
- refusal to participate in the study at any stage
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
St. Hedwig of Silesia Hospital in Trzebnica
Trzebnica, Lower Silesian Voivodeship, 55-100
Justyna Mazurek, PhD, 695180984 ext. +48, justyna.mazurek@umed.wroc.pl
Małgorzata Ratajczyk, MSc
About this study
Official title: Antigravity Treadmill Rehabilitation After Lower Limb Arthroplasty in Older Adults
The study aims to evaluate the efficacy of antigravity treadmill training and body weight-supported treadmill training in the rehabilitation of elderly patients (60-75 years) following hip or knee arthroplasty.
Read the detailed description
This randomized controlled trial will recruit 60 patients aged 60-75 years, within 3 months after total hip or knee arthroplasty, admitted to the Rehabilitation Unit of St. Jadwiga Hospital in Trzebnica. Participants will be randomly assigned to one of three groups: (i) body weight-supported treadmill group (n=20), (ii) antigravity treadmill group (n=20), or (iii) control group receiving conventional gait training (n=20). All patients will receive comprehensive daily therapy for 6 weeks, including kinesitherapy, ergotherapy, and physical therapy procedures under professional supervision.
- Conditions
- Arthropathy, Osteoarthritis
- Being tested
- Antigravity Treadmill Training, Body Weight-Supported Treadmill Training, Conventional rehabilitation
- Keywords
- arthroplasty, balance, fall risk, gait rehabilitation, psychological outcomes
- Medical subject headings
- Joint Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antigravity Treadmill TrainingBehavioural
Antigravity treadmill training uses air pressure to reduce effective body weight during walking, minimizing joint load while preserving gait mechanics. The 6-week intervention includes five sessions per week within a 120-minute daily kinesitherapy program. Treadmill speed is individualized at baseline and increased by 0.5 km/h every two weeks. Unloading is progressively reduced: 60% support in weeks 1-2, 40% in weeks 3-4, and 20% in weeks 5-6, allowing gradual adaptation to full weight-bearing.
Body Weight-Supported Treadmill TrainingBehavioural
Body weight-supported treadmill training uses a harness-based system to partially offload body weight, promoting safe ambulation and gait normalization in early postoperative rehabilitation. The 6-week intervention includes five sessions per week within the 120-minute daily kinesitherapy program. Treadmill speed is individualized at baseline and increased by 0.5 km/h every two weeks, depending on tolerance. The unloading level remains constant and is individually adjusted to ensure safety.
Conventional rehabilitationBehavioural
Conventional rehabilitation follows standard postoperative protocols after hip or knee arthroplasty. The 6-week program includes five weekly sessions. Gait training is conducted in hospital corridors under physiotherapist supervision, using assistive devices as needed (crutches, walkers). Daily therapy includes 120 minutes of kinesiotherapy (general exercises and gait training), 30 minutes of ergotherapy to improve functional independence, and three individualized physical therapy procedures (laser therapy, magnetic therapy, or electrotherapy) tailored to patient needs.
| Study group | Role | What they receive |
|---|---|---|
| Antigravity Treadmill Training Group | Experimental | Conventional orthopedic rehabilitation supplemented by antigravity yreadmill training Receives: Behavioral: Antigravity Treadmill Training; Behavioral: Conventional rehabilitation |
| Body Weight-Supported Treadmill Training | Active comparator | Conventional orthopedic rehabilitation supplemented by body weight-supported treadmill training Receives: Behavioral: Body Weight-Supported Treadmill Training; Behavioral: Conventional rehabilitation |
| Control Group | Active comparator | Conventional orthopedic rehabilitation Receives: Behavioral: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a 24-item questionnaire used to assess pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Each item is scored on a scale from 0 to 4, with higher scores indicating greater severity. The total score is calculated as the sum of three subscales: pain (0-20 points), stiffness (0-8 points), and physical function (0-68 points), yielding a global score range of 0 to 96. Higher scores reflect worse joint function, greater pain, and more severe stiffness.
Measured: Baseline and after 6 weeks of intervention
Secondary outcomes (9)
Berg Balance Scale
The Berg Balance Scale (BBS) is a 14-item instrument assessing static and dynamic balance, scored 0 to 4 per item, with a total score ranging from 0 to 56. Higher scores indicate better balance and lower fall risk.
Measured: Baseline and after 6 weeks of intervention
Patient Health Questionnaire
The Patient Health Questionnaire (PHQ-9) is a 9-item self-report scale measuring depressive symptoms, scored from 0 to 3 per item, with total scores ranging from 0 to 27. Higher scores indicate greater depression severity.
Measured: Baseline and after 6 weeks of intervention
Perceived Stress Scale
The Perceived Stress Scale (PSS-10) is a 10-item instrument assessing perceived stress over the past month. Each item is rated 0-4, with total scores ranging from 0 to 40. Higher scores indicate higher perceived stress levels.
Measured: Baseline and after 6 weeks of intervention
Falls Efficacy Scale-International
The Falls Efficacy Scale-International (FES-I) consists of 16 items assessing concern about falling during various activities. Items are scored from 1 to 4, with total scores ranging from 16 to 64. Higher scores reflect greater fear of falling.
Measured: Baseline and after 6 weeks of intervention
Step Length
Step length (in centimetres) for the left and right lower limbs will be assessed during walking on an antigravity treadmill with integrated gait analysis. Values will be reported separately for each leg. An increase in step length is expected following the intervention.
Measured: Baseline and after 6 weeks of intervention
Step Time
Step time (in milliseconds) for the left and right lower limbs will be measured during treadmill walking using an antigravity system. Values will be reported separately for each leg. A decrease in step time is expected following the intervention.
Measured: Baseline and after 6 weeks of intervention
Stance Phase Duration
Stance phase duration (in percent of gait cycle) for the left and right lower limbs will be recorded during walking on an antigravity treadmill. Values will be reported separately for each leg.
Measured: Baseline and after 6 weeks of intervention
Swing Phase Duration
Swing phase duration (in percent of gait cycle) for the left and right lower limbs will be assessed using gait analysis on an antigravity treadmill. Results will be reported separately for each leg.
Measured: Baseline and after 6 weeks of intervention
Vertical Load
Vertical load (in percent of body weight) applied by the left and right lower limbs during stance will be measured using an antigravity treadmill with embedded load sensors. Values will be reported separately for each leg.
Measured: Baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start15 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthropathyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University, Jan Dlugosz University in Czestochowa
- Responsible party
- Principal investigator, Błażej Cieślik, Wroclaw University of Health and Sport Sciences
- Investigators
- Justyna Mazurek, PhD, Principal investigator, Wroclaw Medical UniversityBłażej Cieślik, PhD, Principal investigator, Wroclaw University of Health and Sport SciencesJoanna Szczepańska-Gieracha, Prof., Study director, Wroclaw University of Health and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040878
- Sponsor's protocol ID
- KE-U/74/2025
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antigravity Treadmill Rehabilitation After Lower Limb Arthroplasty in Older Adults
- ClinicalTrials.gov ID
- NCT07040878
- Acronym / sponsor ID
- KE-U/74/2025
- Conditions
- Arthropathy, Osteoarthritis
- Keywords
- arthroplasty, balance, fall risk, gait rehabilitation, psychological outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Wroclaw Medical University, Jan Dlugosz University in Czestochowa
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Jun 2025 (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.
The study aims to evaluate the efficacy of antigravity treadmill training and body weight-supported treadmill training in the rehabilitation of elderly patients (60-75 years) following hip or knee arthroplasty.
Detailed description
This randomized controlled trial will recruit 60 patients aged 60-75 years, within 3 months after total hip or knee arthroplasty, admitted to the Rehabilitation Unit of St. Jadwiga Hospital in Trzebnica. Participants will be randomly assigned to one of three groups: (i) body weight-supported treadmill group (n=20), (ii) antigravity treadmill group (n=20), or (iii) control group receiving conventional gait training (n=20). All patients will receive comprehensive daily therapy for 6 weeks, including kinesitherapy, ergotherapy, and physical therapy procedures under professional supervision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antigravity Treadmill Training Group | Experimental | Behavioral: Antigravity Treadmill Training, Behavioral: Conventional rehabilitationConventional orthopedic rehabilitation supplemented by antigravity yreadmill training |
| Body Weight-Supported Treadmill Training | Active comparator | Behavioral: Body Weight-Supported Treadmill Training, Behavioral: Conventional rehabilitationConventional orthopedic rehabilitation supplemented by body weight-supported treadmill training |
| Control Group | Active comparator | Behavioral: Conventional rehabilitationConventional orthopedic rehabilitation |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- individuals who have recently undergone hip or knee joint arthroplasty surgeries aged 60 years and above.
Key exclusion criteria (4 listed)
- cognitive impairments that prevent independent completion of research questionnaires
- history of consciousness disturbances, psychotic disorders, bipolar disorder, or other severe psychiatric illnesses
- functional status preventing independent ambulation (wheelchair-bound or bedridden patients; orthopedic devices such as crutches or walker allowed)
- refusal to participate in the study at any stage
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 |
|---|---|---|
| Antigravity Treadmill TrainingAntigravity treadmill training uses air pressure to reduce effective body weight during walking, minimizing joint load while preserving gait mechanics. The 6-week intervention includes five sessions per week within a 120-minute daily kinesitherapy program. Treadmill speed is individualized at baseline and increased by 0.5 km/h every two weeks. Unloading is progressively reduced: 60% support in weeks 1-2, 40% in weeks 3-4, and 20% in weeks 5-6, allowing gradual adaptation to full weight-bearing. | Behavioural | Antigravity Treadmill Training Group |
| Body Weight-Supported Treadmill TrainingBody weight-supported treadmill training uses a harness-based system to partially offload body weight, promoting safe ambulation and gait normalization in early postoperative rehabilitation. The 6-week intervention includes five sessions per week within the 120-minute daily kinesitherapy program. Treadmill speed is individualized at baseline and increased by 0.5 km/h every two weeks, depending on tolerance. The unloading level remains constant and is individually adjusted to ensure safety. | Behavioural | Body Weight-Supported Treadmill Training |
| Conventional rehabilitationConventional rehabilitation follows standard postoperative protocols after hip or knee arthroplasty. The 6-week program includes five weekly sessions. Gait training is conducted in hospital corridors under physiotherapist supervision, using assistive devices as needed (crutches, walkers). Daily therapy includes 120 minutes of kinesiotherapy (general exercises and gait training), 30 minutes of ergotherapy to improve functional independence, and three individualized physical therapy procedures (laser therapy, magnetic therapy, or electrotherapy) tailored to patient needs. | Behavioural | Antigravity Treadmill Training Group, Body Weight-Supported Treadmill Training, Control Group |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Baseline and after 6 weeks of intervention
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a 24-item questionnaire used to assess pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Each item is scored on a scale from 0 to 4, with higher scores indicating greater severity. The total score is calculated as the sum of three subscales: pain (0-20 points), stiffness (0-8 points), and physical function (0-68 points), yielding a global score range of 0 to 96. Higher scores reflect worse joint function, greater pain, and more severe stiffness.
9 secondary outcomes
Berg Balance Scale
Time frame: Baseline and after 6 weeks of intervention
Patient Health Questionnaire
Time frame: Baseline and after 6 weeks of intervention
Perceived Stress Scale
Time frame: Baseline and after 6 weeks of intervention
Falls Efficacy Scale-International
Time frame: Baseline and after 6 weeks of intervention
Step Length
Time frame: Baseline and after 6 weeks of intervention
Step Time
Time frame: Baseline and after 6 weeks of intervention
Stance Phase Duration
Time frame: Baseline and after 6 weeks of intervention
Swing Phase Duration
Time frame: Baseline and after 6 weeks of intervention
Vertical Load
Time frame: Baseline and after 6 weeks of intervention
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 27 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Justyna Mazurek, PhD principal investigator
Wroclaw Medical University
Błażej Cieślik, PhD principal investigator
Wroclaw University of Health and Sport Sciences
Joanna Szczepańska-Gieracha, Prof. study director
Wroclaw University of Health and Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antigravity Treadmill Training, Body Weight-Supported Treadmill Training and Conventional rehabilitation in people with Arthropathy and Osteoarthritis, run by Wroclaw University of Health and Sport Sciences 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 1 inclusion and 4 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 27 Jun 2025. 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 Justyna Mazurek, PhD (695180984 ext. +48, justyna.mazurek@umed.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (time frame: Baseline and after 6 weeks of intervention). 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 27 Jun 2025; AzTrials last refreshed its copy on 27 Oct 2026.