What this Trial Is About

Introduction Stroke remains the third leading cause of death and disability combined. Post-stroke cognitive impairment (PSCI) is a common neurological sequela that may affect up to 80% of stroke survivors. Several systematic reviews and studies indicated that Tai Chi benefits patients with mild cognitive impairment, leading to significant improvement in cognitive function. 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. 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. Methods 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. 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. 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. 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. 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. 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 by validated scales. 1. Cognitive function will be measured using the MoCA scale. 2. Upper limb function will be measured using Fugl-Meyer Test Upper Limb section and Wolf Motor Function Test 3. Balance control will be measured using the Berg Balance Scale and the Trunk Impairment Scale 4. Depressive symptoms will be measured by the 15 items Geriatric Depression Scale short form. 5. The Modified Barthel Index will be used to assess ADL. 6. QoL will be assessed using the Chinese version of Stroke-Specific Quality of Life Scale. 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 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 in terms of usability, acceptability, and applicability. Adverse events measurements Any unexpected adverse events during the intervention period will be monitored. Semi-structured interview We will conduct semi-structured in-depth interviews using a pre-designed semi-structured interview guide. 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. 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. 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.

A Sitting Tai Chi Programme for Chronic Stroke Survivors With Post-stroke Cognitive Impairment