Clinical trial NCT06876012: Impact of Tai Chi in Cervical Myelopathy
Official title: Impact of Tai Chi on Balance and Fall Risk in Patients with Cervical Myelopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Myelopathy
Balance Assessment
Fall Risk
Keywords: Surgery
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Timed Up and Go Test - Baseline
timeFrame: Baseline
measure: Timed Up and Go Test - 6 weeks
timeFrame: 6 weeks post-operatively
measure: Timed Up and Go Test - 3 months
timeFrame: 3 months post-operatively
measure: Timed Up and Go Test - 6 months
timeFrame: 6 months post-operatively
measure: Timed Up and Go Test - 12 months
timeFrame: 12 months post-operatively
Secondary outcomes:
measure: 10-Step Tandem Gait Test - Baseline
timeFrame: Baseline
measure: 10-Step Tandem Gait Test - 6 weeks
timeFrame: 6 weeks post-operatively
measure: 10-Step Tandem Gait Test - 3 months
timeFrame: 3 months post-operatively
measure: 10-Step Tandem Gait Test - 6 months
timeFrame: 6 months post-operatively
measure: 10-Step Tandem Gait Test - 12 Month
timeFrame: 12 months post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: West Virginia University School of Medicine, Department of Orthopaedics
name: Scott Daffner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University School of Public Health
name: Andrya Durr, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.