Tai Chi for Stroke Rehabilitation on Balance and Cognition (TCSR)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tai Chi exercise
symptom management
Sponsored by

About this trial
This is an interventional supportive care trial for Stroke focused on measuring stroke, Tai ji, postural balance, cognition
Eligibility Criteria
Inclusion Criteria:
- diagnosed as stroke at least for 3 months upto 2 years
- eligible to participate rehabilitation therapy referred by primary physician
Exclusion Criteria:
- not able to understand questionnaires
- not able to stand alone for balance test
Sites / Locations
- Chungnam National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tai Chi group
Symptom management group
Arm Description
Tai Chi exercise, twice a week, one hour per session. participated in Tai Chi either while seated or standing upon their comfort level.
manage stroke symptom through phone and text message along with other rehabilitation therapy.
Outcomes
Primary Outcome Measures
balance
postural stability test will be measured by standard computerized test
Secondary Outcome Measures
activities of daily living
activities of daily living will be measured by Modified rankin scale
knee muscle strength
knee flexor and extensor strength by isokinetic testing measured by Biodex
Full Information
NCT ID
NCT02868840
First Posted
July 27, 2016
Last Updated
September 11, 2017
Sponsor
Chungnam National University
Collaborators
National Research Foundation, Singapore, Chungnam National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02868840
Brief Title
Tai Chi for Stroke Rehabilitation on Balance and Cognition
Acronym
TCSR
Official Title
Evaluating the Effect of Tai Chi Applied Stroke Rehabilitation on Physical and Cognitive Functioning
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chungnam National University
Collaborators
National Research Foundation, Singapore, Chungnam National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Tai Chi, an ancient Chinese martial art, is a low intense aerobic exercise characterized by continuous movements that embrace the mind, body, and spirit. Tai Chi addresses the integration and balance of mind and body using the fundamental principles of slow, smooth, and continuous movement control, and the transfer of body weight while maintaining an upright and relaxed posture. The present randomized clinical trial project aims to apply the suggested principles as the typical features of Tai Chi applied stroke rehabilitation, and to evaluate the effects on physical (balance), psychological, and cognitive function.
Detailed Description
Cerebrovascular disease is a major global concern. The individuals with stroke would suffer from disease associated symptoms which influence their functioning in everyday life. These symptom clusters were usually known to be sharing similar underlying mechanisms. It is clear that the development of effective stroke rehabilitation involves interdisciplinary team approach to manage physical, social, cognitive, and psychological functioning in this population.
Tai Chi, an ancient Chinese martial art, is a low intense aerobic exercise characterized by continuous movements that embrace the mind, body, and spirit. Tai Chi addresses the integration and balance of mind and body using the fundamental principles of slow, smooth, and continuous movement control, and the transfer of body weight while maintaining an upright and relaxed posture. The newly developed style of Tai Chi for health programs is the seated Tai Chi, which shares the common Tai Chi principles while being modified to adjust the movements for patients with limited mobility.
The present randomized clinical trial project aims to apply the suggested principles as the typical features of Tai Chi applied stroke rehabilitation, and to evaluate the effects on physical (balance), psychological, and cognitive function. Only a few studies ever addressed the feasibility of Tai Chi for stroke rehabilitation, and the relationship between cognition and balance in this population is still very early stage of investigation. The main purpose of our collaborating project is to explore the direct relationship between cognition and balance in stroke patients during their rehabilitation process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Tai ji, postural balance, cognition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi group
Arm Type
Experimental
Arm Description
Tai Chi exercise, twice a week, one hour per session. participated in Tai Chi either while seated or standing upon their comfort level.
Arm Title
Symptom management group
Arm Type
Active Comparator
Arm Description
manage stroke symptom through phone and text message along with other rehabilitation therapy.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi exercise
Other Intervention Name(s)
seated Tai Chi
Intervention Description
exercise twice a week each for one hour
Intervention Type
Behavioral
Intervention Name(s)
symptom management
Other Intervention Name(s)
message counselling
Intervention Description
sending text message weekly to manage symptoms related to stroke
Primary Outcome Measure Information:
Title
balance
Description
postural stability test will be measured by standard computerized test
Time Frame
3 months, 6 months
Secondary Outcome Measure Information:
Title
activities of daily living
Description
activities of daily living will be measured by Modified rankin scale
Time Frame
3 months, 6 months
Title
knee muscle strength
Description
knee flexor and extensor strength by isokinetic testing measured by Biodex
Time Frame
3 months, 6 months
Other Pre-specified Outcome Measures:
Title
cognition
Description
measured by Korean version of Montreal Cognitive Assessment
Time Frame
3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed as stroke at least for 3 months upto 2 years
eligible to participate rehabilitation therapy referred by primary physician
Exclusion Criteria:
not able to understand questionnaires
not able to stand alone for balance test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhayun Song, PhD
Organizational Affiliation
Chungnam National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26291978
Citation
Chen BL, Guo JB, Liu MS, Li X, Zou J, Chen X, Zhang LL, Yue YS, Wang XQ. Effect of Traditional Chinese Exercise on Gait and Balance for Stroke: A Systematic Review and Meta-Analysis. PLoS One. 2015 Aug 20;10(8):e0135932. doi: 10.1371/journal.pone.0135932. eCollection 2015.
Results Reference
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PubMed Identifier
25888114
Citation
Tao J, Rao T, Lin L, Liu W, Wu Z, Zheng G, Su Y, Huang J, Lin Z, Wu J, Fang Y, Chen L. Evaluation of Tai Chi Yunshou exercises on community-based stroke patients with balance dysfunction: a study protocol of a cluster randomized controlled trial. BMC Complement Altern Med. 2015 Feb 25;15:31. doi: 10.1186/s12906-015-0555-1.
Results Reference
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Tai Chi for Stroke Rehabilitation on Balance and Cognition
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