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Evaluating the Effect of Tai Chi applied Stroke Rehabilitation on Physical and Cognitive Functioning

Last registered on April 05, 2016

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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
March 31, 2016, 9:38 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
April 05, 2016, 12:29 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Region

Primary Investigator

Affiliation
Chungnam National Unviersity

Other Primary Investigator(s)

Additional Trial Information

Status
On going
Start date
2016-03-01
End date
2017-03-31
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 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.
External Link(s)

Registration Citation

Citation
Song, Rhayun. 2016. "Evaluating the Effect of Tai Chi applied Stroke Rehabilitation on Physical and Cognitive Functioning." AEA RCT Registry. April 05. https://doi.org/10.1257/rct.1145-4.0
Former Citation
Song, Rhayun. 2016. "Evaluating the Effect of Tai Chi applied Stroke Rehabilitation on Physical and Cognitive Functioning." AEA RCT Registry. April 05. https://www.socialscienceregistry.org/trials/1145/history/7516
Sponsors & Partners

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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
2016-04-12
Intervention End Date
2016-11-30

Primary Outcomes

Primary 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
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
Primary 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

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design

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.
Experimental Design Details
The randomized clinical trial was applied.
the recuitment is processing at the outpatient clinic of stroke center in D city Korea.
the inclusion criteria : stroke patients diagnosed between 3 to 24 months, who are referred by primary physician to participate in rehabilitation programs; be able to do ADL with assistant; be able to understand the questionnaire or interview contents.
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.

the intervention for both groups are provided for 12 weeks, twice a week, one hour per session.
at the end of the program, all participatns from both group were referred to the physiotherapist for the posttest measure, without revealing their assigned groups.
Randomization Method
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.
Randomization Unit
unit of randomization is individual based.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
80 individuals with 40 : 40 assignment to each group
Sample size: planned number of observations
80 subjects
Sample size (or number of clusters) by treatment arms
40 subjects for either experimental or control group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
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

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials