- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07428343
Effects of Tai Chi Exercises on Patients Functional Status With Knee Osteoarthritis
Assessment of the Effects of Tai Chi Exercises on Balance and Functional Status in Patients With Knee Osteoarthritis
Brief summary
The goal of this clinical trial is to evaluate whether Tai Chi exercise, used as an adjunct to standard physiotherapy, can improve balance, functional status, pain, and knee joint mobility in older adults (65-75 years) diagnosed with knee osteoarthritis (gonarthrosis), compared with standard physiotherapy alone and physiotherapy combined with virtual reality-based training.
The main questions it aims to answer are:
Does adding Tai Chi to standard physiotherapy lead to greater improvements in static and dynamic balance (Berg Balance Scale, Timed Up and Go test) in patients with knee osteoarthritis?
Does Tai Chi result in superior improvements in pain intensity (VAS), functional status (WOMAC), and knee joint range of motion compared with standard physiotherapy and VR-based training?
Researchers will compare three intervention arms-standard physiotherapy, standard physiotherapy plus virtual reality (Kinect-based biofeedback training), and standard physiotherapy plus Tai Chi-to determine whether Tai Chi provides greater clinical and functional benefits than the other rehabilitation approaches.
Participants will:
Receive standard inpatient physiotherapy for knee osteoarthritis
Additionally perform one of the following interventions for 30 minutes daily over 4 weeks:
Tai Chi exercises led by a qualified therapist, focusing on balance, controlled movement, and pain-free execution
Virtual reality-based balance training using a Kinect system
Undergo assessments before and after the intervention period, including pain, balance, functional performance, and knee joint mobility measures
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Krakow, Poland, 31-066
- Department of Biomechanics and Kinesiology, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed knee osteoarthritis
- Age between 60 and 80 years
Exclusion Criteria:
- Patients with significant knee joint effusion and excessive valgus or varus deformity of the knee joint
- Post-surgical status
- Patients with a body mass index (BMI) ≥ 34
- Patients after knee joint surgery
- Patients with severe clinically significant comorbidities that could interfere with study outcomes
- Lack of patient consent to participate in the study, as well as non-compliance or diagnosed psychiatric disorders
- History of stroke and other neurological disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Standard Physiotherapy Combined with Tai Chi Balance Training
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In addition to standard therapy, instead of balance training, the participant performed Tai Chi exercises daily for 30 minutes under the supervision of a qualified therapist.
The Tai Chi sessions emphasized balance in a variety of positions engaging the knee joint; the exercises were performed in smooth sequences combined with deep breathing.
During the sessions, particular attention was paid to movement quality and the absence of pain during movement.
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Active Comparator: Inpatient Physiotherapy with Manual Therapy, Physical Modalities, and Conventional Balance Training
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who, as part of inpatient physiotherapy, underwent a comprehensive treatment program consisting of: manual therapy-20 minutes daily, including soft tissue techniques and mobilization of the knee joint-and physical therapy modalities including electrotherapy, laser therapy, magnetotherapy, and ultrasound therapy.
The patients also performed balance-supporting exercises in the form of balance training, which included: balancing on sensorimotor cushions for 10 minutes in various directions, resistance exercises-leg press on a machine for 3 sets of 15-20 repetitions, semi-squats on sensorimotor cushions for 3 sets of 20 repetitions, and core stability exercises in the supine position for 10 minutes.
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Active Comparator: Standard Physiotherapy Combined with Kinect-Based Virtual Reality Balance Training
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where, in addition to standard therapy, instead of conventional balance training, the group additionally received exercises using a Kinect-based system on the iStander device (Alreh Medical, Łódź, Poland), which enables safe and engaging therapy in a controlled virtual environment with the use of biofeedback.
The exercises were delivered in the form of game-based activities for 30 minutes daily at a moderate level of difficulty.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total score on the Berg Balance Scale.
Time Frame: Baseline; Day 1 (09 May 2025) Final assessment: after 4 weeks (06 June 2025)
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Assessment of static and dynamic balance using a 14-item scale.
The unit of measurement is points (range 0-56), where a higher score indicates better balance.
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Baseline; Day 1 (09 May 2025) Final assessment: after 4 weeks (06 June 2025)
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Score on the WOMAC questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index).
Time Frame: Baseline; Day 1 (09 May 2025) Final assessment: after 4 weeks (06 June 2025)
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Assessment of the severity of osteoarthritis symptoms (pain, stiffness, and physical function).
The unit of measurement is points (sum of 24 items), where a higher score indicates poorer functional status and greater pain.
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Baseline; Day 1 (09 May 2025) Final assessment: after 4 weeks (06 June 2025)
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Time to complete the Timed Up and Go (TUG) test.
Time Frame: Baseline; Day 1 (09 May 2025) Final assessment: after 4 weeks (06 June 2025)
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Assessment of functional mobility and fall risk.
The unit of measurement is time in seconds required to stand up from a chair, walk 3 meters, turn around, return, and sit down again.
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Baseline; Day 1 (09 May 2025) Final assessment: after 4 weeks (06 June 2025)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Grzegorz Mańko, PhD, Department of Biomechanics and Kinesiology, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Cracow, Poland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 118.0043.1.208.2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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