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Effect of Tai Chi Exercise on Mechanical Joint Loading in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03621631
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Edward Via Virginia College of Osteopathic Medicine

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Behavioral: Optimized Tai Chi intervention Behavioral: Traditional Tai Chi intervention Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Real Time Biofeedback Tai Chi Training for Knee Osteoarthritis: A Feasibility Study
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: optimized Tai Chi intervention Behavioral: Optimized Tai Chi intervention
Optimized Tai Chi intervention
Other Name: OTC

Active Comparator: traditional Tai Chi intervention Behavioral: Traditional Tai Chi intervention
Traditional Tai Chi intervention
Other Name: TTC




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621631


Locations
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United States, Alabama
VCOM-Auburn, Rehabilitation Biomechanics Lab Recruiting
Auburn, Alabama, United States, 36830
Contact: Wei Liu, PhD    334-442-4044    wliu@auburn.vcom.edu   
Sponsors and Collaborators
Edward Via Virginia College of Osteopathic Medicine
National Center for Complementary and Integrative Health (NCCIH)
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Responsible Party: Edward Via Virginia College of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT03621631    
Other Study ID Numbers: 2016-050
1K23AT009568-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary outcome measure will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edward Via Virginia College of Osteopathic Medicine:
knee osteoarthritis
Tai Chi
Biofeedback
External Knee Adduction Moment
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases