- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06876012
Impact of Tai Chi in Cervical Myelopathy
Impact of Tai Chi on Balance and Fall Risk in Patients With Cervical Myelopathy
The goal of this observational study is to determine if patients with cervical myelopathy who participate in a Tai Chi program will demonstrate improved gait and balance compared to patients who undergo usual care.
Participants must be 18 years or older and have a diagnosis of cervical myelopathy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Eicher, BS, CCRP
- Phone Number: 304-293-2485
- Email: jeicher@hsc.wvu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of Cervical Myelopathy with planned surgery
- 18 years of age or older
- Able to participate in intervention (attend and participate in classes)
Exclusion Criteria:
- Wheelchair bound at initial visit
- Other verified potential cause of gait instability/balance problems
- Unable to participate in intervention (unable to attend/participate in classes)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of Care (Control)
Subjects will follow the current standard of care procedures utilized by the WVU Spine Center.
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Experimental: Intervention Group (Tai Chi)
These subjects will participate in 12 sessions of Tai Chi class over the course of 6 weeks.
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Twelve sessions (six weeks) of a Tai Chi Program to assist with balance and fall risk.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go Test - Baseline
Time Frame: Baseline
|
Establish a baseline score. The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. Setup: The person sits in a standard armchair. Instructions: On the command "Go," the person stands up, walks 3 meters (about 10 feet) at a comfortable pace, turns around, walks back to the chair, and sits down. Timing: The time taken from the command "Go" until the person sits back down is recorded. This is recorded in minutes:seconds. Scoring Normal Mobility: Completing the test in less than 10 seconds. Mild Mobility Impairment: Completing the test in 10-19 seconds. Moderate Mobility Impairment: Completing the test in 20-29 seconds. Severe Mobility Impairment: Taking 30 seconds or more to complete the test. A time of 12 seconds or more indicates a higher risk of falling. |
Baseline
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Timed Up and Go Test - 6 weeks
Time Frame: 6 weeks post-operatively
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The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. This is recorded in minutes:seconds. Setup: The person sits in a standard armchair. Instructions: On the command "Go," the person stands up, walks 3 meters (about 10 feet) at a comfortable pace, turns around, walks back to the chair, and sits down. Timing: The time taken from the command "Go" until the person sits back down is recorded. This is recorded in minutes:seconds. Scoring Normal Mobility: Completing the test in less than 10 seconds. Mild Mobility Impairment: Completing the test in 10-19 seconds. Moderate Mobility Impairment: Completing the test in 20-29 seconds. Severe Mobility Impairment: Taking 30 seconds or more to complete the test. A time of 12 seconds or more indicates a higher risk of falling. |
6 weeks post-operatively
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Timed Up and Go Test - 3 months
Time Frame: 3 months post-operatively
|
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. This is recorded in minutes:seconds. Setup: The person sits in a standard armchair. Instructions: On the command "Go," the person stands up, walks 3 meters (about 10 feet) at a comfortable pace, turns around, walks back to the chair, and sits down. Timing: The time taken from the command "Go" until the person sits back down is recorded. This is recorded in minutes:seconds. Scoring Normal Mobility: Completing the test in less than 10 seconds. Mild Mobility Impairment: Completing the test in 10-19 seconds. Moderate Mobility Impairment: Completing the test in 20-29 seconds. Severe Mobility Impairment: Taking 30 seconds or more to complete the test. A time of 12 seconds or more indicates a higher risk of falling. |
3 months post-operatively
|
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Timed Up and Go Test - 6 months
Time Frame: 6 months post-operatively
|
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. This is recorded in minutes:seconds. Setup: The person sits in a standard armchair. Instructions: On the command "Go," the person stands up, walks 3 meters (about 10 feet) at a comfortable pace, turns around, walks back to the chair, and sits down. Timing: The time taken from the command "Go" until the person sits back down is recorded. This is recorded in minutes:seconds. Scoring Normal Mobility: Completing the test in less than 10 seconds. Mild Mobility Impairment: Completing the test in 10-19 seconds. Moderate Mobility Impairment: Completing the test in 20-29 seconds. Severe Mobility Impairment: Taking 30 seconds or more to complete the test. A time of 12 seconds or more indicates a higher risk of falling. |
6 months post-operatively
|
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Timed Up and Go Test - 12 months
Time Frame: 12 months post-operatively
|
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. This is recorded in minutes:seconds. Setup: The person sits in a standard armchair. Instructions: On the command "Go," the person stands up, walks 3 meters (about 10 feet) at a comfortable pace, turns around, walks back to the chair, and sits down. Timing: The time taken from the command "Go" until the person sits back down is recorded. This is recorded in minutes:seconds. Scoring Normal Mobility: Completing the test in less than 10 seconds. Mild Mobility Impairment: Completing the test in 10-19 seconds. Moderate Mobility Impairment: Completing the test in 20-29 seconds. Severe Mobility Impairment: Taking 30 seconds or more to complete the test. A time of 12 seconds or more indicates a higher risk of falling. |
12 months post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10-Step Tandem Gait Test - Baseline
Time Frame: Baseline
|
Establish a baseline score. The 10-Step Tandem Gait Test asks participants to walk a straight line making a toe-to-heal touch with each step at the subject's own velocity. The number of steps made before the first misstep is counted. After first 10-step tandem gait test, the subject turns around and repeats the tandem gait test in the same line and the number of steps is counted in the same manner. This is a graded score from 0-4. The higher grade demonstrates better gait. Scoring Grade 4: Completes all 10 steps without any instability. Grade 3: Completes 8-9 steps with minimal instability. Grade 2: Completes 6-7 steps with moderate instability. Grade 1: Completes 4-5 steps with significant instability. Grade 0: Completes fewer than 4 steps or is unable to perform the test due to severe instability. |
Baseline
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10-Step Tandem Gait Test - 6 weeks
Time Frame: 6 weeks post-operatively
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The 10-Step Tandem Gait Test asks participants to walk a straight line making a toe-to-heal touch with each step at the subject's own velocity. The number of steps made before the first misstep is counted. After first 10-step tandem gait test, the subject turns around and repeats the tandem gait test in the same line and the number of steps is counted in the same manner. This is a graded score from 0-4. The higher grade demonstrates better gait. Scoring Grade 4: Completes all 10 steps without any instability. Grade 3: Completes 8-9 steps with minimal instability. Grade 2: Completes 6-7 steps with moderate instability. Grade 1: Completes 4-5 steps with significant instability. Grade 0: Completes fewer than 4 steps or is unable to perform the test due to severe instability. |
6 weeks post-operatively
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10-Step Tandem Gait Test - 3 months
Time Frame: 3 months post-operatively
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The 10-Step Tandem Gait Test asks participants to walk a straight line making a toe-to-heal touch with each step at the subject's own velocity. The number of steps made before the first misstep is counted. After first 10-step tandem gait test, the subject turns around and repeats the tandem gait test in the same line and the number of steps is counted in the same manner. This is a graded score from 0-4. The higher grade demonstrates better gait. Scoring Grade 4: Completes all 10 steps without any instability. Grade 3: Completes 8-9 steps with minimal instability. Grade 2: Completes 6-7 steps with moderate instability. Grade 1: Completes 4-5 steps with significant instability. Grade 0: Completes fewer than 4 steps or is unable to perform the test due to severe instability. |
3 months post-operatively
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10-Step Tandem Gait Test - 6 months
Time Frame: 6 months post-operatively
|
The 10-Step Tandem Gait Test asks participants to walk a straight line making a toe-to-heal touch with each step at the subject's own velocity. The number of steps made before the first misstep is counted. After first 10-step tandem gait test, the subject turns around and repeats the tandem gait test in the same line and the number of steps is counted in the same manner. This is a graded score from 0-4. The higher grade demonstrates better gait. Scoring Grade 4: Completes all 10 steps without any instability. Grade 3: Completes 8-9 steps with minimal instability. Grade 2: Completes 6-7 steps with moderate instability. Grade 1: Completes 4-5 steps with significant instability. Grade 0: Completes fewer than 4 steps or is unable to perform the test due to severe instability. |
6 months post-operatively
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10-Step Tandem Gait Test - 12 Month
Time Frame: 12 months post-operatively
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The 10-Step Tandem Gait Test asks participants to walk a straight line making a toe-to-heal touch with each step at the subject's own velocity. The number of steps made before the first misstep is counted. After first 10-step tandem gait test, the subject turns around and repeats the tandem gait test in the same line and the number of steps is counted in the same manner. This is a graded score from 0-4. The higher grade demonstrates better gait. Scoring Grade 4: Completes all 10 steps without any instability. Grade 3: Completes 8-9 steps with minimal instability. Grade 2: Completes 6-7 steps with moderate instability. Grade 1: Completes 4-5 steps with significant instability. Grade 0: Completes fewer than 4 steps or is unable to perform the test due to severe instability. |
12 months post-operatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott Daffner, MD, West Virginia University School of Medicine, Department of Orthopaedics
- Study Director: Andrya Durr, PhD, West Virginia University School of Public Health
Publications and helpful links
General Publications
- Qi Y, Zhang X, Zhao Y, Xie H, Shen X, Niu W, Wang Y. The effect of wheelchair Tai Chi on balance control and quality of life among survivors of spinal cord injuries: A randomized controlled trial. Complement Ther Clin Pract. 2018 Nov;33:7-11. doi: 10.1016/j.ctcp.2018.07.004. Epub 2018 Jul 20.
- Tsang WW, Gao KL, Chan KM, Purves S, Macfarlane DJ, Fong SS. Sitting tai chi improves the balance control and muscle strength of community-dwelling persons with spinal cord injuries: a pilot study. Evid Based Complement Alternat Med. 2015;2015:523852. doi: 10.1155/2015/523852. Epub 2015 Jan 21.
- Chen Y, Wan A, Mao M, Sun W, Song Q, Mao D. Tai Chi practice enables prefrontal cortex bilateral activation and gait performance prioritization during dual-task negotiating obstacle in older adults. Front Aging Neurosci. 2022 Nov 18;14:1000427. doi: 10.3389/fnagi.2022.1000427. eCollection 2022.
- Zu Y, Luo L, Chen X, Xie H, Yang CR, Qi Y, Niu W. Characteristics of corticomuscular coupling during wheelchair Tai Chi in patients with spinal cord injury. J Neuroeng Rehabil. 2023 Jun 17;20(1):79. doi: 10.1186/s12984-023-01203-x.
- Chen W, Li M, Li H, Lin Y, Feng Z. Tai Chi for fall prevention and balance improvement in older adults: a systematic review and meta-analysis of randomized controlled trials. Front Public Health. 2023 Sep 1;11:1236050. doi: 10.3389/fpubh.2023.1236050. eCollection 2023.
- Voukelatos A, Cumming RG, Lord SR, Rissel C. A randomized, controlled trial of tai chi for the prevention of falls: the Central Sydney tai chi trial. J Am Geriatr Soc. 2007 Aug;55(8):1185-91. doi: 10.1111/j.1532-5415.2007.01244.x.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2409042637
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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