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Abstract
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Before
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 wheelchair bound patients.
The present RCT 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.
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After
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 wheelchair bound patients.
The present feasibility 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 effect of long-term Tai Chi program on balance and functional outcome in stroke patients during their rehabilitation process.
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Trial Start Date
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March 01, 2016
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September 01, 2015
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Last Published
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April 05, 2016 12:29 AM
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March 17, 2017 10:15 AM
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Intervention Start Date
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April 12, 2016
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October 01, 2015
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Intervention End Date
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Before
November 30, 2016
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September 30, 2016
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Primary Outcomes (End Points)
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Before
Outcome variables are included to assess physical and cognitive functioning in stroke patients.
1. Symptoms clusters of stroke pateitns (developed by PI)
2. Stroke specific QOL
3. Balance
1) Berg Balance Scale
2) computerized balance scale
3) 10 m walking test
4) Functional Ambulation Categories
5) Trunk impairment scale
6) knee muscle strength (cybex)
4. Cognitive function
1) Montreal Cognitive Assessment
2) MMSE
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After
Outcome variables are included to assess physical and cognitive functioning in stroke patients.
1. Symptoms clusters of stroke pateitns (developed by PI)
2. Stroke specific QOL
3. Balance by Berg Balance Scale
4. physical functioning (ADL, TUG)
5. muscle strength (grip)
4. Cognitive function
1) Montreal Cognitive Assessment
2) MMSE
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Experimental Design (Public)
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Before
The randomized clinical trial was applied.
the recuitment is processing at the outpatient clinic of stroke center.
once the primary physician screened the potential candiates according to the inclusion criteria, the researcher explained them about the study purpose and the random assisgnment process either to Tai Chi exercise program or to the text message couseling program for their symptom management.
All candidates were explained the choice of the group assignment was random. When the candidates signed the consent form, they participated in pretest measure with an assigned physiotherapist at rehabilitation center, who are not involved in recruiting process.
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After
The feasibility project on clinical trial was applied.
the recuitment is processing at the outpatient stroke center.
once the primary physician screened the potential candiates according to the inclusion criteria, the researcher explained them about the study purpose and the random assisgnment process either to Tai Chi exercise program or to the text message couseling program for their symptom management.
All candidates were explained the choice of the group assignment was random. When the candidates signed the consent form, they participated in pretest measure with an assigned physiotherapist at rehabilitation center, who are not involved in recruiting process.
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Randomization Method
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Before
The random assignment of the subjects was conducted by the 3rd research assistant who are not involving in recruitment nor assessment. The random number drawn from the computer software is simply assigned to the study participants, and transferred to other research assistants so that they can notify to the subjects their assigned group right before the intervention.
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After
during the feasibility study with mixed design, no randomization was applied. The random assignment of the subjects will be conducted as Phase II study of clinical trial.
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Randomization Unit
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Before
unit of randomization is individual based.
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After
not applicable for feasibility study, during phase II, unit of randomization is individual based.
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Planned Number of Clusters
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Before
80 individuals with 40 : 40 assignment to each group
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After
feasibility study: 14 recruitment for 12 months
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Planned Number of Observations
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80 subjects
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After
14 recruitment for 12 months
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Sample size (or number of clusters) by treatment arms
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Before
40 subjects for either experimental or control group.
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14 recruitments
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Power calculation: Minimum Detectable Effect Size for Main Outcomes
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Before
effect size d=0.8 for balance, two tailed test, power .8 for t-test would require 26 subjects for each group. considering the dropouts, we are aiming 40 for each group.
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After
for feasibility study we end up with 14 recruitment for 12 months intervention with 5 time points of measurement; for Phase II clinical trial, we will recruit 40 per each arm; with effect size d=0.8 for balance, two tailed test, power .8 for t-test would require 26 subjects for each group. considering the dropouts, we are aiming 40 for each group.
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Intervention (Hidden)
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Before
Tai Chi applied stroke rehabilitation
provided one hour session, twice weekly for 12 weeks by professional certified Tai Chi instructors
the components of the study are follows:
1) seated Tai Chi program
-composed of 21 Sun style movements (standardized form of Tai Chi for Arthritis Program developed by Dr Lam in 2000).
-applied to meet the health condition of stroke patients from seated to standing and walking
-progressive and stepwise application of the movements for intensity and duration
-Qi gong breathing exercise
-Tai Chi walking exercise for balanding and muscle strength
-meditation components for mind-body exercise
2) rehabilitation principles
-posture alignment
-self efficacy for ADL
-accepting himself/herself for each ability of physical and cognitive function
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After
Tai Chi applied stroke rehabilitation
provided one hour session, twice weekly for 12 months by professional certified Tai Chi instructors
the components of the study are follows:
1) seated Tai Chi program
-composed of 21 Sun style movements (standardized form of Tai Chi for Arthritis Program developed by Dr Lam in 2000).
-applied to meet the health condition of stroke patients from seated to standing and walking
-progressive and stepwise application of the movements for intensity and duration
-Qi gong breathing exercise
-Tai Chi walking exercise for balanding and muscle strength
-meditation components for mind-body exercise
2) rehabilitation principles
-posture alignment
-self efficacy for ADL
-accepting himself/herself for each ability of physical and cognitive function
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