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Trial registered on ANZCTR

Registration number

ACTRN12625000564459

Ethics application status

Approved

Date submitted

14/04/2025

Date registered

2/06/2025

Date last updated

2/06/2025

Date data sharing statement initially provided

2/06/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Testing the effectiveness of the community stroke program in Singapore

Scientific title

Testing the clinical effectiveness of the community stroke program in Singapore: A stepped-wedge cluster study

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

ACTRN12616001195448 is the pilot feasibility study

Health condition

Health condition(s) or problem(s) studied:

stroke

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Staff involved
Program facilitators: A fully registered occupational therapist working in the participating centre will be nominated or invited to attend a face-to-face two-day training from the master trainer (PI Xu) to become the program facilitator. The training workshop occurs two months prior to start of the intervention. The program facilitator is someone who has a strong interest in working with stroke survivors living in the community. He or she should be able to guide stroke participants in learning effectively through group discussions and sessions with expert speakers. The facilitator monitors each participant’s recovery progress through weekly exercises, peer support sharing, and personalized goal reviews. The facilitator also empowers stroke survivors, along with their family members or caregivers to take an active role in rehabilitation, risk reduction, and safety strategies to improve long-term health and quality of life.

Program co-facilitators: A therapy assistant from the same participating centres will be nominated to attend a two-day training from the master trainer (PI Xu) to become the program co-facilitator. The role of the program co-facilitator is to assist the main facilitator in delivering the weekly sessions and supporting individual stroke participants' learning towards independent living.

Intervention (Program website: https://occupymytime.wixsite.com/create-program)

The studied 8-week program incorporates new leisure and functional activities, comprising eight 2-hour weekly sessions that target increasing community participation and reducing the risk of falling. All sessions are conducted face to face in a small group setting. It begins with an introduction session focusing on goal setting and coping strategies with the caregivers involved. Subsequent sessions cover various themes such as fall prevention, environmental safety and community mobility while incorporating balance and strength exercises. Additionally, topics like medication management and maintaining healthy lifestyles are also explored. The last session includes a goal review and a graduation ceremony as a form of accomplishment for the participants, as well as to promote their sense of self-efficacy towards living in the community.

Caregivers are invited to join specific sessions and are involved in follow-up sessions to reinforce program contents, review the goals, problem-solve in addressing the challenges and develop coping strategies together to meet the participant's needs.

The strength exercises include the following: Leg raises, high squat, heel raises and side hip opening. The duration of each strength exercise is approximately 30 seconds. The balance exercises include side-walking, chair raise, modified Tai Chi, stepping exercises, tandem stand and tandem walk. The exercises will be incorporated during the weekly program sessions. Participants are expected to carry out the exercises in their own time outside of the sessions. Homework sheet containing the individualised exercise presription (based on individual participant's functions) will be used to monitor their compliance.
All exercises are considered low intensity with Borg scale 2-3 RPE. All exercises have been suggested by international and local stroke rehabilitation experts in our earlier studies and tested to be feasible and safe in the earlier feasibility study:
• Xu, T., Clemson, L., O’Loughlin, K., Lannin, N. A., Dean, C., & Koh, G. (2020). The Stepping On after Stroke fall prevention program for community stroke survivors in Singapore: A feasibility study. British Journal of Occupational Therapy, 86(4), 366-375. https://doi.org/10.1177/0308022620946640

Safety measures during exercise sessions

To keep all participants safe during the exercise sessions, all participants will be taught how to set up a safe environment for each exercise, especially doing balance exercises. For instance, the program facilitators will ask participants to hold onto a stable surface (e.g. tables, chairs, wall and handrails) for stability. Participants will be closely supervised by two program facilitators (e.g. one therapist and one therapy assistant). While we highly encourage family members or caregivers to join the program together with stroke participants, family members or caregivers will learn to guide and supervise stroke participants during exercise sessions so that they can do it safely at home for better clinical effects.

Program facilitators will provide physical assistance to individual stroke participants to do balance exercises such as 4-square stepping exercises and modified tai chi when stroke participants require additional support. To keep everyone safe, they will take turns to do these exercises if more participants need physical assistance.
All participants will be assessed for suitability and safety before exercise prescription by a fully registered physiotherapist and the program facilitator (OT). Participants will be told to rest if they have difficulty in doing certain exercises or slow down based on their own pace.

Safety measure during community outing sessions

In the event of an incident (e.g., a fall) during the mobility practice session in the neighborhood, facilitators will follow the organization’s emergency protocol:
- Assess the situation – Check for injuries, consciousness, and pain levels.
- Provide first aid – Address immediate needs (e.g., stop bleeding, stabilize suspected fractures). Avoid moving the participant if injury severity is unclear.
- Contact the centre – Notify supervisors for additional support.
- Escalate care based on severity:
- Minor injuries: Transport to the nearest clinic via wheelchair/assisted walking.
- Severe cases (e.g., inability to move, severe pain, head trauma, suspected fracture): Call 995 for an ambulance and send to A&E. Do not attempt to move the participant unless in danger (e.g., traffic).
- Document the incident – File a report per organizational policy.

The research team will discuss with each participating centre (cluster) to decide the starting date of the intervention. As part of this non-randomised stepped-wedge cluster study, we will recruit the participants from two participating centres in each phase and conduct baseline screening and assessment. Phase I will include 2 centres in 2025; phase II will include another 2 centres in 2026.

In each phase, an 8-week period during which Group A will receive the intervention and Group B will receive usual therapy, followed by another 8-week period where the groups will switch and the intervention will no longer be offered to Group A

Intervention code [1]

Rehabilitation

Intervention code [2]

Prevention

Intervention code [3]

Lifestyle

Comparator / control treatment

In each phase, participants in the second group (Group B) will be the waitlist control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The extent of community mobility

Timepoint [1]