An interventional study of Antigravity Treadmill Training and Body Weight-Supported Treadmill Training in Arthropathy and Osteoarthritis, sponsored by Wroclaw University of Health and Sport Sciences. Recruiting at 1 site in Poland. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Wroclaw University of Health and Sport Sciences · Not applicable, Interventional, and Treatment
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.
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Wroclaw University of Health and Sport Sciences is the lead sponsor of 46 studies on the registry; 10 are open to participants now.
Compared within Osteoarthritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Joint Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Conventional orthopedic rehabilitation supplemented by antigravity yreadmill training
Behavioral: Antigravity Treadmill Training · Behavioral: Conventional rehabilitation
Conventional orthopedic rehabilitation supplemented by body weight-supported treadmill training
Behavioral: Body Weight-Supported Treadmill Training · Behavioral: Conventional rehabilitation
Conventional orthopedic rehabilitation
Behavioral: Conventional rehabilitation
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 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 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.
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.
Time frame: Baseline and after 6 weeks of intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and after 6 weeks of intervention
Plan to share: No
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Started May 2025 (actual). Primary completion is estimated for Dec 2025, 7 months after the start.
Of 578 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 7 months is below that.
Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.
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Wroclaw University of Health and Sport Sciences