NCT06876012

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Dec 2026

Status
not yet recruiting

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

March 12, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 12, 2025

Last Update Submit

April 10, 2026

Conditions

Cervical MyelopathyBalance AssessmentFall Risk

Keywords

Surgery

Outcome Measures

Primary Outcomes (5)

  • Timed Up and Go Test - 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

    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

    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

    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

    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 Outcomes (5)

  • 10-Step Tandem Gait Test - Baseline

    Baseline

  • 10-Step Tandem Gait Test - 6 weeks

    6 weeks post-operatively

  • 10-Step Tandem Gait Test - 3 months

    3 months post-operatively

  • 10-Step Tandem Gait Test - 6 months

    6 months post-operatively

  • 10-Step Tandem Gait Test - 12 Month

    12 months post-operatively

Study Arms (2)

Standard of Care (Control)

NO INTERVENTION

Subjects will follow the current standard of care procedures utilized by the WVU Spine Center.

Intervention Group (Tai Chi)

EXPERIMENTAL

These subjects will participate in 12 sessions of Tai Chi class over the course of 6 weeks.

Other: Tai Chi Program

Interventions

Tai Chi ProgramOTHER

Twelve sessions (six weeks) of a Tai Chi Program to assist with balance and fall risk.

Intervention Group (Tai Chi)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Cervical Myelopathy with planned surgery
  • years of age or older
  • Able to participate in intervention (attend and participate in classes)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 36466597BACKGROUND

  • 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.

    PMID: 37330516BACKGROUND

  • 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.

    PMID: 25688276BACKGROUND

  • 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.

    PMID: 30396629BACKGROUND

  • 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.

    PMID: 37736087BACKGROUND

  • 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.

    PMID: 17661956BACKGROUND

Study Officials

  • Scott Daffner, MD

    West Virginia University School of Medicine, Department of Orthopaedics

    PRINCIPAL INVESTIGATOR

  • Andrya Durr, PhD

    West Virginia University School of Public Health

    STUDY DIRECTOR

Central Study Contacts

Jennifer Eicher, BS, CCRP

CONTACT

304-293-2485jeicher@hsc.wvu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 14, 2025

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04