Impact of Tai Chi in Cervical Myelopathy

April 10, 2026 updated by: Scott Daffner, West Virginia University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients who meet inclusion criteria and choose to participate will be randomized to either participate in a Tai Chi falls-prevention program or continue with usual care. Those in the Tai Chi program will attend a pre-determined number of Tai Chi classes for a period of approximately 6-8 weeks. Investigators will assess their gait and balance at the time of enrollment and at several timepoints after they have participated in the class (similar timepoints for those randomized to usual care).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of Care (Control)
Subjects will follow the current standard of care procedures utilized by the WVU Spine Center.
Experimental: Intervention Group (Tai Chi)
These subjects will participate in 12 sessions of Tai Chi class over the course of 6 weeks.
Other: Tai Chi Program
Twelve sessions (six weeks) of a Tai Chi Program to assist with balance and fall risk.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Timed Up and Go Test - 6 weeks
Time Frame: 6 weeks 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 weeks post-operatively
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
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
10-Step Tandem Gait Test - 6 weeks
Time Frame: 6 weeks 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 weeks post-operatively
10-Step Tandem Gait Test - 3 months
Time Frame: 3 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.
3 months post-operatively
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
10-Step Tandem Gait Test - 12 Month
Time Frame: 12 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.
12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West Virginia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2409042637

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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