Knee OsteoarthritisNCT03621631
Effect of Tai Chi Exercise on Mechanical Joint Loading in Knee Osteoarthritis
A study testing Optimized Tai Chi intervention and Traditional Tai Chi intervention in people with Knee Osteoarthritis, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Optimized Tai Chi intervention and Traditional Tai Chi intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health San Antonio, Rehabilitation Biomechanics Lab
San Antonio, Texas, 78258
About this study
Official title: Real Time Biofeedback Tai Chi Training for Knee Osteoarthritis: A Feasibility Study
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.
Read the detailed description
Disabilities that arise from typical impairments of knee osteoarthritis (OA) include decreased muscle strength, reduced range of motion, and decreased aerobic cardiovascular function. A large number of individuals with knee OA experience disability and require rehabilitation. Traditional TC intervention has been a promising therapeutic intervention in knee OA, but the efficacy of TC as a knee OA intervention has proven inconclusive presumably because individuals with knee OA perform different TC components (steps) with widely varying mechanical knee joint loads. This variation could be a confounding factor in the way in which TC affects knee OA. Therefore, a feasibility study is proposed here to quantify external knee adduction moment (EKAM) response to the different TC steps, and then determine if it is feasible to use biofeedback of torque acting on the knee to modify some TC steps so as to reduce the EKAM they produce. Those TC steps whose EKAM can be easily reduced below mean EKAM during walking and those already below that level will constitute an optimized form of TC for knee OA; the remainder will be discarded. A phase 1 randomized controlled trial will be conducted to compare the optimized TC intervention to traditional TC training in reducing EKAM. The proposed research represents the first study to identify the biomechanical mechanisms of TC and to target EKAM by using a real-time biofeedback approach to manipulate EKAM during TC performance.
- Conditions
- Knee Osteoarthritis
- Being tested
- Optimized Tai Chi intervention, Traditional Tai Chi intervention
- Keywords
- knee osteoarthritis, Tai Chi, Biofeedback, External Knee Adduction Moment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized Tai Chi interventionBehavioural
Also called OTC
Optimized Tai Chi intervention
Traditional Tai Chi interventionBehavioural
Also called TTC
Traditional Tai Chi intervention
| Study group | Role | What they receive |
|---|---|---|
| optimized Tai Chi intervention | Experimental | optimized Tai Chi intervention Receives: Behavioral: Optimized Tai Chi intervention |
| traditional Tai Chi intervention | Active comparator | traditional Tai Chi intervention Receives: Behavioral: Traditional Tai Chi intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start27 Aug 2018
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), The University of Texas Health Science Center at San Antonio
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621631
- Sponsor's protocol ID
- 2016-050
- Other IDs
- 1K23AT009568-01A1
- Status last verified
- Feb 2024
- First submitted
- 31 Jul 2018
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary outcome measure will be made available
Publications
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.
PubMed 39961273
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Time Biofeedback Tai Chi Training for Knee Osteoarthritis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03621631
- Acronym / sponsor ID
- 2016-050
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, Tai Chi, Biofeedback, External Knee Adduction Moment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), The University of Texas Health Science Center at San Antonio
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Disabilities that arise from typical impairments of knee osteoarthritis (OA) include decreased muscle strength, reduced range of motion, and decreased aerobic cardiovascular function. A large number of individuals with knee OA experience disability and require rehabilitation. Traditional TC intervention has been a promising therapeutic intervention in knee OA, but the efficacy of TC as a knee OA intervention has proven inconclusive presumably because individuals with knee OA perform different TC components (steps) with widely varying mechanical knee joint loads. This variation could be a confounding factor in the way in which TC affects knee OA. Therefore, a feasibility study is proposed here to quantify external knee adduction moment (EKAM) response to the different TC steps, and then determine if it is feasible to use biofeedback of torque acting on the knee to modify some TC steps so as to reduce the EKAM they produce. Those TC steps whose EKAM can be easily reduced below mean EKAM during walking and those already below that level will constitute an optimized form of TC for knee OA; the remainder will be discarded. A phase 1 randomized controlled trial will be conducted to compare the optimized TC intervention to traditional TC training in reducing EKAM. The proposed research represents the first study to identify the biomechanical mechanisms of TC and to target EKAM by using a real-time biofeedback approach to manipulate EKAM during TC performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optimized Tai Chi intervention | Experimental | Behavioral: Optimized Tai Chi interventionoptimized Tai Chi intervention |
| traditional Tai Chi intervention | Active comparator | Behavioral: Traditional Tai Chi interventiontraditional Tai Chi intervention |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized Tai Chi interventionAlso: OTCOptimized Tai Chi intervention | Behavioural | optimized Tai Chi intervention |
| Traditional Tai Chi interventionAlso: TTCTraditional Tai Chi intervention | Behavioural | traditional Tai Chi intervention |
Primary outcome
change from baseline knee joint mechanical load at 4 weeks
Time frame: baseline and 4 weeks
knee joint mechanical load will be measured by using high speed cameras and force plates to estimate external knee adduction moment (EKAM)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 39961273Yang 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary outcome measure will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized Tai Chi intervention and Traditional Tai Chi intervention in people with Knee Osteoarthritis, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline knee joint mechanical load at 4 weeks (time frame: baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.