Antigravity Treadmill After Joint Arthroplasty

NCT ID: NCT07040878

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Arthropathy Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Antigravity Treadmill Training Group

Conventional orthopedic rehabilitation supplemented by antigravity yreadmill training

Group Type EXPERIMENTAL

Antigravity Treadmill Training

Intervention Type BEHAVIORAL

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.

Conventional rehabilitation

Intervention Type BEHAVIORAL

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.

Body Weight-Supported Treadmill Training

Conventional orthopedic rehabilitation supplemented by body weight-supported treadmill training

Group Type ACTIVE_COMPARATOR

Body Weight-Supported Treadmill Training

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Control Group

Conventional orthopedic rehabilitation

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type BEHAVIORAL

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.

Interventions

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Antigravity Treadmill Training

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.

Intervention Type BEHAVIORAL

Body Weight-Supported Treadmill Training

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.

Intervention Type BEHAVIORAL

Conventional rehabilitation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* individuals who have recently undergone hip or knee joint arthroplasty surgeries aged 60 years and above.

Exclusion Criteria

* 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role collaborator

Jan Dlugosz University in Czestochowa

OTHER

Sponsor Role collaborator

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role lead

Responsible Party

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Błażej Cieślik

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Justyna Mazurek, PhD

Role: PRINCIPAL_INVESTIGATOR

Wroclaw Medical University

Błażej Cieślik, PhD

Role: PRINCIPAL_INVESTIGATOR

Wroclaw University of Health and Sport Sciences

Joanna Szczepańska-Gieracha, Prof.

Role: STUDY_DIRECTOR

Wroclaw University of Health and Sport Sciences

Locations

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St. Hedwig of Silesia Hospital in Trzebnica

Trzebnica, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Justyna Mazurek, PhD

Role: CONTACT

695180984 ext. +48

Błażej Cieślik, PhD

Role: CONTACT

500138483 ext. +48

Facility Contacts

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Justyna Mazurek, PhD

Role: primary

695180984 ext. +48

Other Identifiers

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KE-U/74/2025

Identifier Type: -

Identifier Source: org_study_id

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