NCT07428343

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

February 4, 2026

Last Update Submit

February 19, 2026

Conditions

Keywords

Osteoarthritisolder adultsfunctional indicatorsfall risktai chi

Outcome Measures

Primary Outcomes (3)

  • Total score on the Berg Balance Scale.

    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.

    Baseline; Day 1 (09 May 2025) Final assessment: after 4 weeks (06 June 2025)

  • Score on the WOMAC questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index).

    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.

    Baseline; Day 1 (09 May 2025) Final assessment: after 4 weeks (06 June 2025)

  • Time to complete the Timed Up and Go (TUG) test.

    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.

    Baseline; Day 1 (09 May 2025) Final assessment: after 4 weeks (06 June 2025)

Study Arms (3)

Standard Physiotherapy Combined with Tai Chi Balance Training

EXPERIMENTAL
Other: Tai Chi training

Inpatient Physiotherapy with Manual Therapy, Physical Modalities, and Conventional Balance Training

ACTIVE COMPARATOR
Other: Comprehensive Inpatient Physiotherapy with other standard therapies

Standard Physiotherapy Combined with Kinect-Based Virtual Reality Balance Training

ACTIVE COMPARATOR
Other: Kinect-Based Virtual Reality Balance Training with Biofeedback

Interventions

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.

Standard Physiotherapy Combined with Tai Chi Balance Training

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.

Inpatient Physiotherapy with Manual Therapy, Physical Modalities, and Conventional Balance Training

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.

Standard Physiotherapy Combined with Kinect-Based Virtual Reality Balance Training

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed knee osteoarthritis
  • Age between 60 and 80 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomechanics and Kinesiology, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College

Krakow, 31-066, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Grzegorz Mańko, PhD

    Department of Biomechanics and Kinesiology, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Cracow, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Biomechanics and Kinesiology, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Cracow, Poland

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 23, 2026

Study Start

May 9, 2025

Primary Completion

June 13, 2025

Study Completion

June 13, 2025

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations