Evaluating the Effect of Tai Chi applied Stroke Rehabilitation on Physical and Cognitive Functioning
Last registered on March 17, 2017

Pre-Trial

Trial Information
General Information
Title
Evaluating the Effect of Tai Chi applied Stroke Rehabilitation on Physical and Cognitive Functioning
RCT ID
AEARCTR-0001145
Initial registration date
March 31, 2016
Last updated
March 17, 2017 10:33 AM EDT
Location(s)

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Primary Investigator
Affiliation
Chungnam National Unviersity
Other Primary Investigator(s)
Additional Trial Information
Status
On going
Start date
2014-11-01
End date
2017-04-30
Secondary IDs
NRF 2013-2241-03
Abstract
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.
External Link(s)
Registration Citation
Citation
Song, Rhayun. 2017. "Evaluating the Effect of Tai Chi applied Stroke Rehabilitation on Physical and Cognitive Functioning." AEA RCT Registry. March 17. https://www.socialscienceregistry.org/trials/1145/history/15095
Experimental Details
Interventions
Intervention(s)
Tai Chi for health program has been recognized as evidence based practice in scientific world with many RCT studies and meta analysis. However, the applicability and feasibility of Tai Chi intervention for those with functional disability is quite new to the area, with huge implication to the intervention in this population. This group needs to participate certain type of exercise to gain independence of their daily activities and the routine physiotherapy style of safe and effective exercise intervention is usually boring and painful to them, resulting in low participation rate. Tai Chi can be introduced as a safe and effective exercise modality to this population and its low dropout rates has been proven in previous studies with Tai Chi.
Intervention Start Date
2015-09-01
Intervention End Date
2017-03-31
Outcomes
Outcomes (end points)
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
Outcomes (explanation)
1. symptom clusters
65 items assessed on 4-pioint Likert type scales
5 categories of stroke related symptoms developed by qualitative study in first year of the present study.
consisting of Mobility, Sense, Cognition, Verbalization, Memory, Affect and others (swallowing).
higher scores indicate more frequently perceiving symptoms

2. stroke specific QOL developed by Williams and Weisberger et al(1999)
49 items assessed on 5-point Guttman-type scales
◦Each item is answered using 1 of 3 different response sets
•Provides both summary and domain specific scores
◦Summary scores are composed of an unweighted average of the 12 domain average scores
•Scores range from 49-245
•Higher scores indicate better functioning
•The twelve domains include
◦Mobility
◦Energy
◦Upper Extremity Function
◦Work and Productivity
◦Mood
◦Self-care
◦Social Roles
◦Family Roles
◦Vision
◦Language
◦Thinking
Experimental Design
Experimental Design
1. The feasibility project on clinical trial was applied.
-the recruitment is processing at the primary health care setting in the community. one group with multiple outcome assessment (3 month interval) for 12 months
-an exit interview with qualitative analysis
2. Phase II Randomized Clinical Trial.
-the recruitment is processing at the outpatient stroke center.
once the primary physician screened the potential candidates according to the inclusion criteria, the researcher explained them about the study purpose and the random assignment process either to Tai Chi exercise program or to the text message counseling 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.
Experimental Design Details
Not available
Randomization Method
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.
Randomization Unit
1. not applicable for feasibility study for 12 months
2. during phase II, unit of randomization is individual based.
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
1. feasibility study: 14 recruitment for 12 months
2. RCT 30 per each arm for 6 months
Sample size: planned number of observations
1. feasibility study: 14 recruitment for 12 months 2. RCT 30 per each arm for 6 months
Sample size (or number of clusters) by treatment arms
1. feasibility study: 14 recruitment for 12 months
2. RCT 30 per each arm for 6 months
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
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.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Chungnam National University IRB
IRB Approval Date
2015-05-26
IRB Approval Number
2-1046881-A-N-01-01505-HR-020