NCT Number: NCT07040878
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.
Interested in participating?
Request Info60 year–75 year
All sexes
Interventional
Not applicable
Trzebnica, Lower Silesian Voivodeship, 55-100, Poland
Location status: Recruiting
Justyna Mazurek, PhD
CONTACT
695180984 ext. +48
Małgorzata Ratajczyk, MSc
SUB_INVESTIGATOR
Olga Witczak
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline and after 6 weeks of intervention
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
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
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
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 (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 (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 (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 (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 (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.
Contact information is provided by the study sponsor or research team.
Wroclaw University of Health and Sport Sciences
Other
Antigravity Treadmill Rehabilitation After Lower Limb Arthroplasty in Older Adults
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