Antigravity Treadmill After Joint Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-75
SponsorWroclaw University of Health and Sport Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
individuals who have recently undergone hip or knee joint arthroplasty surgeries aged 60 years and above.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Antigravity Treadmill Training
BehavioralAntigravity 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
BehavioralBody 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
BehavioralConventional 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Antigravity Treadmill Training GroupExperimental treatment 2 interventions
Group B: Body Weight-Supported Treadmill TrainingActive comparator 2 interventions
Group C: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 interventionSecondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wroclaw University of Health and Sport Sciences
Lead sponsor
Wroclaw Medical University
Collaborator
Jan Dlugosz University in Czestochowa
Collaborator
Source ClinicalTrials.gov