StrokeTCSRNCT02868840
Tai Chi for Stroke Rehabilitation on Balance and Cognition
A study testing Tai Chi exercise and symptom management in people with Stroke, run by Chungnam National University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Tai Chi exercise and symptom management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as stroke at least for 3 months upto 2 years
- eligible to participate rehabilitation therapy referred by primary physician
Who cannot join
- not able to understand questionnaires
- not able to stand alone for balance test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of Tai Chi Applied Stroke Rehabilitation on Physical and Cognitive Functioning
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Tai Chi exercise, symptom management
- Keywords
- stroke, Tai ji, postural balance, cognition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi exerciseBehavioural
Also called seated Tai Chi
exercise twice a week each for one hour
symptom managementBehavioural
Also called message counselling
sending text message weekly to manage symptoms related to stroke
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi group | Experimental | Tai Chi exercise, twice a week, one hour per session. participated in Tai Chi either while seated or standing upon their comfort level. Receives: Behavioral: Tai Chi exercise |
| Symptom management group | Active comparator | manage stroke symptom through phone and text message along with other rehabilitation therapy. Receives: Behavioral: symptom management |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
postural stability test will be measured by standard computerized test
Measured: 3 months, 6 months
Secondary outcomes (2)
activities of daily living
activities of daily living will be measured by Modified rankin scale
Measured: 3 months, 6 months
knee muscle strength
knee flexor and extensor strength by isokinetic testing measured by Biodex
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJan 2016
- Primary completion30 Mar 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungnam National University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation, Singapore, Chungnam National University Hospital
- Responsible party
- Principal investigator, Rhayun Song, Chungnam National University
- Investigators
- Rhayun Song, PhD, Principal investigator, Chungnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868840
- Sponsor's protocol ID
- ChungnamNU
- Acronym
- TCSR
- Status last verified
- Sep 2017
- First submitted
- 27 Jul 2016
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26291978Tao 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.
PubMed 25888114
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Tai Chi Applied Stroke Rehabilitation on Physical and Cognitive Functioning
- ClinicalTrials.gov ID
- NCT02868840
- Acronym / sponsor ID
- TCSR / ChungnamNU
- Conditions
- Stroke
- Keywords
- stroke, Tai ji, postural balance, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chungnam National UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation, Singapore, Chungnam National University Hospital
- Study start
- Jan 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi group | Experimental | Behavioral: Tai Chi exerciseTai Chi exercise, twice a week, one hour per session. participated in Tai Chi either while seated or standing upon their comfort level. |
| Symptom management group | Active comparator | Behavioral: symptom managementmanage stroke symptom through phone and text message along with other rehabilitation therapy. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed as stroke at least for 3 months upto 2 years
- eligible to participate rehabilitation therapy referred by primary physician
Key exclusion criteria (2 listed)
- not able to understand questionnaires
- not able to stand alone for balance test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi exerciseAlso: seated Tai Chiexercise twice a week each for one hour | Behavioural | Tai Chi group |
| symptom managementAlso: message counsellingsending text message weekly to manage symptoms related to stroke | Behavioural | Symptom management group |
Primary outcome
balance
Time frame: 3 months, 6 months
postural stability test will be measured by standard computerized test
2 secondary outcomes
activities of daily living
Time frame: 3 months, 6 months
knee muscle strength
Time frame: 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Background: PubMed 26291978Chen 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.
- Background: PubMed 25888114Tao 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhayun Song, PhD principal investigator
Chungnam National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi exercise and symptom management in people with Stroke, run by Chungnam National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance (time frame: 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868840, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.