NCT03621631

Brief Summary

This project is designed to identify the biomechanical mechanisms of Tai Chi (TC) exercise and test a novel optimized TC intervention by modifying newly identified mechanisms for those with knee osteoarthritis (OA) and to assess the changes in mechanical load with the intervention. It combines unique real time torque biofeedback approach, and uses external knee adduction moment (EKAM) as modulation target tailored to TC intervention in this population. The potential benefit from this project is to provide biomechanical insights of TC and this novel TC approach may produce meaningful changes of mechanical load in these patients who can learn and practice safely during this intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable knee-osteoarthritis

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

August 27, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

September 15, 2025

Status Verified

February 1, 2024

Enrollment Period

5.9 years

First QC Date

July 31, 2018

Last Update Submit

September 8, 2025

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritisTai ChiBiofeedbackExternal Knee Adduction Moment

Outcome Measures

Primary Outcomes (1)

  • change from baseline knee joint mechanical load at 4 weeks

    knee joint mechanical load will be measured by using high speed cameras and force plates to estimate external knee adduction moment (EKAM)

    baseline and 4 weeks

Study Arms (2)

optimized Tai Chi intervention

EXPERIMENTAL

optimized Tai Chi intervention

Behavioral: Optimized Tai Chi intervention

traditional Tai Chi intervention

ACTIVE COMPARATOR

traditional Tai Chi intervention

Behavioral: Traditional Tai Chi intervention

Interventions

Optimized Tai Chi interventionBEHAVIORAL

Optimized Tai Chi intervention

Also known as: OTC
optimized Tai Chi intervention
Traditional Tai Chi interventionBEHAVIORAL

Traditional Tai Chi intervention

Also known as: TTC
traditional Tai Chi intervention

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OA participants will be diagnosed based on the American College of Rheumatology classification criteria.
  • Knee pain average level \> 3 cm on a 10 cm visual analog scale,
  • Kellgren / Lawrence scale of 2-3 on radiographs.
  • Pain/tenderness over the medial region or lateral region of the knee on physical examination.
  • The participants will have 40 years of age or older and have no TCC experience prior this study.

You may not qualify if:

  • a history of lower extremity joint replacement
  • intra-articular knee injection (steroid, hyaluronic acid) within the previous 6 months
  • systemic rheumatoid arthritic condition affecting the knee clinically or radiographically,
  • report of any of the following health problems (heart condition, chest pain during periods of activity or rest)
  • currently seeking or receiving physical therapy for knee OA,
  • having a medical condition precluding the participant from undergoing physical activity or biomechanical gait analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Health San Antonio, Rehabilitation Biomechanics Lab

San Antonio, Texas, 78258, United States

Location

Related Publications (1)

  • Yang F, Markides K, Reistetter TA, Moore AA, Liu W. Effects of Optimal Tai Chi forms in alleviating knee pain among Hispanic people with knee osteoarthritis: A case series. Complement Ther Clin Pract. 2025 May;59:101961. doi: 10.1016/j.ctcp.2025.101961. Epub 2025 Feb 12.

    PMID: 39961273DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 8, 2018

Study Start

August 27, 2018

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

September 15, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary outcome measure will be made available

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available within 6 month of study completion
Access Criteria
Data access requests will be reviewed by an external independent review panel.

Locations

US(1)