Effects of a Sitting Tai Chi Programme for Chronic Stroke Survivors With Post-stroke Cognitive Impairment: A Pilot Randomised Controlled Trial
Phase: NA
Conditions: Stroke, Cognitive Impairment
Sponsor: Chinese University of Hong Kong

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Research proposal (Date 19.9.2025) 
 
 
Project title: Effects of a sitting Tai Chi programme for chronic stroke survivors with 
post-stroke cognitive impairment: A pilot randomised controlled trial 
 
Introduction 
Stroke remains the third leading cause of death and disability combined (GBD Stroke 
Risk Factor Collaborators, 2024). The number of people who experience a stroke, die 
from it, or live with a disability after a stroke has increased significantly worldwide 
between 1990 and 2021. The estimated global cost of stroke exceeds US$ 890 billion 
(0.66% of the global Gross Domestic Product) annually and is projected to nearly 
double by 2050 (Feigin et al., 2025). Post-stroke cognitive impairment (PSCI) is a 
common neurological sequela that may affect up to 80% of stroke survivors. Stroke 
survivors with PSCI experience a lower quality of life due to reduced self-management 
capabilities and difficulty engaging socially (Chau et al., 2023; Qu et al., 2015). 
Several systematic reviews and studies indicate that Tai Chi can support stroke 
rehabilitation, with evidence showing significant improvements in physical functions 
and psychological well-being, including limb functions, ambulation, activities of daily 
living (ADL), quality of life (QoL), and cognitive function (Lyu et al., 2018; Song et 
al., 2021; Yu et al., 2022). Shao et al.'s (2024) review also indicates that Tai Chi benefits 
patients with mild cognitive impairment, leading to significant improvement in 
cognitive function as measured by the Montreal Cognitive Assessment (MoCA). 
Our previous study adopted a tailored sitting Tai Chi programme for the 
rehabilitation of subacute stroke survivors without any cognitive impairment. The 
results of the randomised controlled trial (RCT) showed that upper limb function, 
balance control, ADL, depressive symptoms, and QoL were significantly improved 
compared to the control group (Zhao et al., 2022). To better understand the usefulness 
of the sitting Tai Chi programme for chronic stroke survivors with cognitive 
impairment and how it might affect other rehabilitation outcomes, this study was 
proposed to examine its feasibility and preliminary effectiveness. 
 
Aims and objectives 
The aim of this pilot RCT is to assess the feasibility, acceptability and preliminary 
effectiveness of a sitting Tai Chi programme using a mixed methods approach. 
Specifically, the objectives are to explore 1) whether and in what way this pilot RCT 
of the intervention is feasible and can be carried out as planned; 2) to what extent the 
intervention is satisfying and useful for chronic stroke survivors with PSCI and health 
professionals planning stroke rehabilitation; and 3) how the intervention is able to 
achieve its objectives. 
 
Hypothesis: 
Compared with the usual care, sitting Tai Chi leads to positive of outcomes regarding: 
Coginitve function, upper limb function, balance control, depressive symptoms, ADL 
and QoL. 
 

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Methods 
Study design 
An outcome assessor-blinded RCT will be conducted. Participants will be randomised 
with a 1:1 allocation ratio to either the intervention group or the waiting list control 
group. 
Setting  
We will recruit participants from a geriatric rehabilitation ward (caring for older 
patients with long hospital stays) at a tertiary rehabilitation hospital in Kunming, 
Yunnan, mainland China. The intervention will also be conducted in the same study 
wards.  
Participants  
Individuals who meet the following criteria will be recruited:  
i. 
aged 18 years or above;  
ii. 
have been admitted to a hospital with a clinical diagnosis of first or recurrent 
ischaemic or haemorrhagic stroke, and meet the diagnostic criteria of PSCI 
(classified according to DSM-5 criteria);  
iii. 
in the chronic stage of stroke;  
iv. 
MoCA score: 19–25 (two points are added if the individual has ≤ 6 years of 
education; one point is added if the individual has > 6 and ≤ 12 years of 
education, no points are added for the individual with > 12 years of education);  
v. 
be able to sit independently with or without sitters;  
vi. 
be able to use and raise at least one arm while sitting (upper extremity muscle 
strength ≥ Ⅲ);  
vii. 
have a primary caregiver (a paid or unpaid person who provides most assistance 
to the stroke survivor);  
viii. 
be able to communicate in Chinese and provide informed consent;  
ix. 
is currently hospitalised in this geriatric rehabilitation ward and unlikely to be 
discharged within 3 months.  
 
 
Inclusion criteria for caregivers:  
i. 
age ≥ 18 years;  
ii. 
be able to communicate in Chinese and provide informed consent; 
iii. 
 medically stable and physically able to provide support. 
Individuals will be excluded if other causes of cognitive impairment are present, such 
as Alzheimer’s disease, acquired immune deficiency syndrome, a National Institutes of 
Health Stroke Scale (NIHSS) score >16, severe hearing or visual impairment, severe 
complications following a stroke (e.g., limited comprehension and receptive aphasia, 
venous thrombosis), a history of severe medical conditions or current serious illnesses 

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(e.g. myocardial infarction, use of a cardiac pacemaker or a defibrillator, organ failure, 
malignancy, mental diseases, other neurological diseases such as multiple sclerosis or 
Parkinson’s disease, having received thrombolytic therapy or surgery, joint 
replacement surgeries or fractures within the past six months), pregnant or lactating 
women; prior regular (at least three times/week) Tai Chi practice or other mind-body 
exercises (e.g., Yoga, Qigong, Ba Duanjin, or mindfulness training) within the past six 
months; and those participating in other clinical trials that might influence this study. 
Exclusion criteria for caregivers include impaired cognitive functions (Abbreviated 
Mental Test, AMT ≤ 7), being a medical resident/trainee or a physical therapist,  
having prior regular (at least three times/week) Tai Chi practice or other mind-body 
exercises (e.g., Yoga, Qigong, Ba Duanjin, or mindfulness training) within the past six 
months; and those participating in other clinical trials that might influence affect this 
study. 
Sample size calculation 
Since the aim of this study is to assess the feasibility, acceptability and potential 
effectiveness, we did not undertake a formal sample size calculation for the RCT. We 
applied the criterion of Teare et al. (2014) that an external pilot study should have at 
least 70 measured participants (35 per group) when estimating the pooled standard 
deviation for a continuous outcome. Allowing for 20% dropout, the number of dyads 
in each arm will be 44. A total number of 88 dyads (176 participants) including 44 
stroke survivors and 44 caregivers will be recruited in each group. 
 
For the qualitative part, a purposive sample of 30 stroke survivors with low, medium 
and high satisfaction scores will be invited to participate in a 30-45-minute interview 
to explore their perceptions of participation in sitting Tai Chi to aid recovery and 
improve rehabilitation outcomes. 
 
 
Intervention 
Sitting Tai Chi group: Participants in the sitting Tai Chi group will receive 12 weeks of 
10-form sitting Tai Chi exercise training with a frequency of three days a week and 40 
minutes a day, including 5 minutes warm-up, 30 minutes Tai Chi training, and 5 
minutes cool-down. A registered nurse (RN) with experience with Tai Chi training and 
who participated in our previous study will lead the training session. To avoid 
contamination, the training will be in a separate room and then tell the participants not 
to teach others. The RN will receive refresher training in sitting Tai Chi and learn the 
basics about the condition of PSCI and the characteristics of survivors with PSCI. The 
RN will begin to conduct the intervention after completing an assessment conducted by 
an associate professor of Tai Chi and two graduate students in Tai Chi (who participated 
in the development of this sitting Tai Chi programme). 
 
Control group: Participants in the control group will receive usual care.  That is, regular 
inpatient treatment and care, without additional rehabilitation treatment.  At the end of 
the intervention follow-up assessment, they will be invited to participate in the sitting 
Tai Chi exercise led by the same nurse as well. 
 

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Five series of sitting Tai Chi exercises for stroke survivors with physical impairments, 
each with a target of strengthening the muscles for upper limb function and balance 
while taking into consideration survivors’ physical limitations, were developed. Series 
1 consisted of a 10-form sitting Tai Chi adapted from the 10-form Yang-style 
Wheelchair Tai Chi, which was offered for stroke survivors with minor weakness 
(upper limbs’ muscle strength: 4 or 5). Series 2 to 5 were also ready to cater to the needs 
of stroke survivors with hemiparesis or hemiplegia (upper limbs’ muscle strength: ≤3).  
 
Caregivers will be involved to ensure the safety of stroke participants, encourage their 
participation, and supervise them. Adherence to the treatment protocol will be recorded 
by a research assistant. 
 
Person responsible for project implementation 
 
The co-investigator Ms. Shi Jinping will be responsible for the study implementation 
in Yunnan. She is the nursing leader of the Geriatric Rehabilitation Ward, The Second 
People's Hospital of Kunming. She has over 10 years nursing experience in post-stroke 
rehabilitation. She was major in traditional Chinese medicine nursing. She has more 
than 3 years of experience in Tai Chi practice and has participated in our team's previous 
intervention study on sitting Tai Chi for stroke survivors. She has the ability and 
experience to ensure the implementation of the study. 
 
Assessment and measurement 
Primary outcomes include cognitive function, upper limb function, balance control, and 
depressive symptoms. They will be assessed at baseline, eight weeks, and 12 weeks 
after the commencement of the sitting Tai Chi training. 
(a) Cognitive function will be measured using the MoCA scale, a cognitive screening 
instrument developed and validated to detect mild cognitive impairment. MoCA is a 
brief (approximately 10 min) test that evaluates visuospatial/executive functions, 
naming, verbal memory registration, learning, attention, abstraction, 5-min delayed 
verbal memory and orientation, with a total score of 0–30 (a higher score equals better 
function). The Chinese version of MoCA (Beijing version) is widely used in mainland 
China with good validity, reliability and sensitivity. According to Tan’s study, two 
points are added if the participant has ≤ 6 years of education; one point is added if the 
participant has > 6 and ≤ 12 years of education, and no points are added for the 
participant with > 12 years of education (Tan et al., 2015). 
(b) Upper limb function 
Upper limb function will be measured using Fugl-Meyer Test Upper Limb section 
(FMT-UL) and Wolf Motor Function Test (WMFT) (Thompson-Butel et al., 2015). 
FMT-UL will be used to evaluate upper extremity function in the International 
Classification of Functioning, Disability and Health (ICF) body function and structure 
level. The scale includes eight items related to function of wrist and hand, evaluation 
results are on a 3-point scale ranging from 0 (‘unable accomplish’) to 2 (‘completely 
accomplish’), and has a maximum score of 66. A higher score indicates better upper 
extremity function. The Chinese version is reported to have excellent reliability and 
validity, with an intra-rater intraclass correlation coefficient (ICC) of 0.997 and an 
inter-rater ICC of 0.990. 
The WMFT was often used alongside the FMT-UL to provide a complementary 
description of upper limb function in the ICF activity level. It consists of 17 items 
including time, functional ability and strength domains. Items seven and 14 are strength 

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test with recording the exact weight which the participants can afford. The remaining 
15 items are scored ranging from 0 (‘does not attempt’) to 5 (‘movement appears to be 
normal’), with a total score ranging from 0 to 75. A higher score indicates better 
function. The Chinese version of WMFT was reported to be reliable and valid (intra 
and inter-rater: ICC > 0.981). 
(c) Balance control 
Balance control will be measured using the Berg Balance Scale (BBS) and the Trunk 
Impairment Scale (TIS). 
The 14 items BBS will be used to evaluate the ability to maintain positions, from sitting 
to standing, to close standing, and finally to standing on one leg in the ICF body 
function and structure level. The total score ranges from 0 to 56, with a higher score 
indicates better balance control. The Chinese version of BBS has been reported with 
good reliability and validity (intra and inter-rater ICC: 0.968–0.985 and 0.992–0.998) 
The Trunk Impairment Scale (TIS) was designed to assess the sitting balance and trunk 
control among stroke survivors. It has 17 items which consists of three subscales: static 
sitting balance, dynamic sitting balance and coordination. The total score ranges from 
zero to 23 points, with a higher score indicating a better performance. It has 17 items 
which consists of three subscales: static sitting balance, dynamic sitting balance, and 
coordination. The original English TIS, along with versions in Norwegian, Italian, and 
Spanish has been reported as a valid and reliable scale. The Cronbach α of the Chinese 
version of TIS was 0.86 (Zhao et al., 2021). 
(d) Depressive symptoms 
The 15 items Geriatric Depression Scale short form (GDS-15) will be used to assess 
depressive symptoms. Each item is scored in a dichotomous format: 1= (‘yes’), 0= (‘no’) 
in response to symptoms of depression. The total score is summed (range 0-15). A 
higher score indicates a higher level of depressive symptoms. A score of nine or above 
indicates moderate or severe depression. The Chinese version of GDS-15 has 
demonstrated good validity and reliability (Cronbach’s α: 0.78) (Chau et al., 2006). 
Secondary outcomes include ADL and QoL 
(a) ADL 
The Modified Barthel Index (MBI) will be used to assess ADL in the ICF activity level. 
The scale consists of 10 items to score the ability of a person to care for himself which 
includes feeding, moving, and toileting. The total scores range from 0 to 100. A higher 
score suggests better ADL. The psychometric properties of the Chinese version of MBI 
is good (inter and intra rater ICC: 0.968～0.997 and 0.866～0.990). 
(b) QoL 
QoL will be assessed using the Chinese version of Stroke-Specific Quality of Life Scale 
SS-QOL. The scale is specific to the activity and participation domains of the ICF. It 
includes 12 areas affected following a stroke, as covered by 49 items. For each item, 
there are five response options in which the score varies from one to five. Thus, the 
overall scores range from 49 (worst perception of QoL) to 245 (best perception of QoL). 
Higher scores indicate better QoL. The Chinese version of SS-QOL has been reported 
with acceptable validity and good reliability (Cronbach’s α 0.93) (Lo et al., 2017). 
 
Feasibility and Acceptability  
This pilot RCT evaluates the feasibility of the sitting Tai Chi programme. Feasibility is 
evaluated based on recruitment and retention rates from baseline to follow-up. All 

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participants will be invited to fill in a satisfaction survey with the sitting Tai Chi 
programme and the usefulness of its components. 
Satisfaction 
A self-developed User Satisfaction Questionnaire (USQ) will be used to assess stroke 
survivors' satisfaction with the tailored sitting Tai Chi programme in terms of usability, 
acceptability, and applicability. The USQ measures stroke survivors’ level of 
satisfaction from three different aspects, including clarity and applicability of the sitting 
Tai Chi programme, the appropriateness and adequacy of the audio-visual 
demonstration, and the transferability and sustainability of the sitting Tai Chi 
programme in the home environment. Each item is rated on a 5-point Likert scale, and 
a higher score indicates a higher level of satisfaction. 
Adverse events measurements 
Any unexpected adverse events during the intervention period will be monitored by the 
site supervisor, reported to a research assistant, and adverse event causality relating to 
the Tai chi exercise intervention and the severity of adverse events will be analysed.  
Serious adverse events will be reported to the ethics committee immediately. 
Semi-structured interview 
We will conduct semi-structured in-depth interviews using a pre-designed semi-
structured interview guide. 
 
Interview guide 
1. Please share your recovery experience after discharge. Prompts: positives and 
negatives of rehabilitative experiences, post-stroke psychological status and 
participation restrictions 
2. What sort of physical activity have you engaged in recently? Prompts: type, 
frequency, duration 
3. How do you feel about the sitting Tai Chi exercise you have learned? Prompts: 
usefulness, ease of following, enjoyment, or dissatisfaction 
4. Have you practised sitting Tai Chi recently? 
5. How often do you practice sitting Tai Chi? What is the average time it takes you? 
6. What effects has Tai Chi brought about? Prompts: physical benefits, mental benefits 
7. What do you think made you start practising Tai Chi? Prompts: Availability of 
support, recommended by healthcare providers 
8. What do you think caused you to stop practising Tai Chi? Prompts: fatique, pain, 
short hospital stay, inability to remember all the movements, lack of support 
9. What do you think are the barriers to practising Tai Chi? Prompts: fear of falling, 
physical discomfort, lack of motivation 
10. What are your suggestions for improving the Tai Chi training? Prompts: 
intervention components, forms of sitting Tai Chi, dissemination methods, guidance 
11. Will you continue to practice sitting Tai Chi? 
12. Do you have anything we haven't mentioned that you want to share? 
 
Ethical considerations 
Ethical approval will be applied from the Joint Chinese University of Hong Kong- New 
Territories East Cluster Clinical Research Ethics Committee and the study hospital’s 
research ethics committee. Written consent will be obtained from the eligible 
participants.  

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Agreements will be made with the wards of the study hospital on schedules and 
arrangements for participant recruitment. Eligible participants will be informed about 
the study, potential risks or benefits, right to confidentiality, and right to withdrawal 
with no negative consequences. Those who agree to participate in the study will be 
asked to sign a written consent. A card (Appendix 1) indicating participants’ 
involvement in the study and means of urgent contact was provided to each participant 
after obtaining consent. An information sheet about the study and a copy of the signed 
informed consent form was given to the participants. All questionnaires were 
anonymous. All information obtained from the study was kept strictly confidential and 
would be destroyed six years after completion of the study. Each participant will be 
assigned a study ID prior to data collection. Each participant's name along with their 
unique study ID will be documented on a separate file in a locked cabinet. This 
document will be stored separately from other data documents. The data documents 
will be kept in secure locations, and computerised records will be assigned with security 
codes by the PI. Only the PI has access to the information. The federal and institutional 
ethical standards, Hong Kong Personal Data (Privacy) Ordinance, Declaration of 
Helsinki, and ICH-GCP were upheld throughout the study. 
The major potential risk of exercise would be fall. The stroke survivors will perform 
the sitting Tai Chi using a seated position in a wheelchair or stable chair with a seat belt 
fastened. Each participant was required to have their caregiver by their side to provide 
safety protection when doing Tai Chi training. The participant may have a normal 
reaction during exercise at the beginning of the exercise session (e.g. muscle soreness, 
fatigue). 
The inpatient training will be performed in a room right in front of the nurse's station. 
The health professionals could be on the scene of them. The physical assessments will 
be conducted in a seated position and the assessors will stay close to the participants, 
which could effectively prevent falls. The assessments will be conducted at the bedsides. 
 
 
Data collection, consent, and sample storage 
A sociodemographic and clinical data sheet will be used to record the corresponding 
information. The research assistants will screen potentially eligible participants by daily 
reviewing the medical records of all stroke survivors admitted to the study venues.  
 
Data processing and analysis 
 
Statistics analysis will be conducted using the IBM SPSS version 29.0. All primary 
analyses will be conducted on an intention-to-treat basis. Descriptive statistics will be 
used to present participants ’ baseline characteristics and outcome variables. All 
continuous outcomes will be assessed for normality in distribution. Appropriate 
transformation of skewed data will be performed before analysis. Chi-square tests and 
independent t-tests will be used to compare the demographic and clinical characteristics, 
and mean scores of outcomes between the intervention and control groups at baseline. 
A generalized estimating equations (GEE) model will be employed to compare 
differential change of each of the primary and secondary outcomes across the study 
time points between the two groups. 
 
Content analysis will be used to analyse the qualitative data from the participants. 
 

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Data collected from the USQ and semi-structured interviews will be used to identify 
areas for improvement and to guide future enhancements to the sitting Tai Chi 
programme. 
 
 
Trial registry  
This trial will be registered in the ClinicalTrials.gov 
 
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