NCT07040878

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
May 2025Jun 2026

Study Start

First participant enrolled

May 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

June 17, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

arthroplastybalancefall riskgait rehabilitationpsychological outcomes

Outcome Measures

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.

    Baseline and after 6 weeks of intervention

Secondary Outcomes (9)

  • Berg Balance Scale

    Baseline and after 6 weeks of intervention

  • Patient Health Questionnaire

    Baseline and after 6 weeks of intervention

  • Perceived Stress Scale

    Baseline and after 6 weeks of intervention

  • Falls Efficacy Scale-International

    Baseline and after 6 weeks of intervention

  • Step Length

    Baseline and after 6 weeks of intervention

  • +4 more secondary outcomes

Study Arms (3)

Antigravity Treadmill Training Group

EXPERIMENTAL

Conventional orthopedic rehabilitation supplemented by antigravity yreadmill training

Behavioral: Antigravity Treadmill TrainingBehavioral: Conventional rehabilitation

Body Weight-Supported Treadmill Training

ACTIVE COMPARATOR

Conventional orthopedic rehabilitation supplemented by body weight-supported treadmill training

Behavioral: Body Weight-Supported Treadmill TrainingBehavioral: Conventional rehabilitation

Control Group

ACTIVE COMPARATOR

Conventional orthopedic rehabilitation

Behavioral: Conventional rehabilitation

Interventions

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.

Antigravity Treadmill Training Group

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.

Body Weight-Supported Treadmill Training

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.

Antigravity Treadmill Training GroupBody Weight-Supported Treadmill TrainingControl Group

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Hedwig of Silesia Hospital in Trzebnica

Trzebnica, Lower Silesian Voivodeship, 55-100, Poland

RECRUITING

MeSH Terms

Conditions

Joint DiseasesOsteoarthritis

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesArthritisRheumatic Diseases

Study Officials

  • Justyna Mazurek, PhD

    Wroclaw Medical University

    PRINCIPAL INVESTIGATOR
  • Błażej Cieślik, PhD

    Wroclaw University of Health and Sport Sciences

    PRINCIPAL INVESTIGATOR
  • Joanna Szczepańska-Gieracha, Prof.

    Wroclaw University of Health and Sport Sciences

    STUDY DIRECTOR

Central Study Contacts

Justyna Mazurek, PhD

CONTACT

Błażej Cieślik, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 27, 2025

Study Start

May 15, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations