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Piloting the “Stepping On after Stroke” falls prevention program for community stroke survivors in Singapore: A feasibility study

Piloting the “Stepping On after Stroke” falls prevention program for community stroke survivors in Singapore: A feasibility study

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001195448
Enrollment
17
Registered
2016-08-30
Start date
2016-11-03
Completion date
2016-12-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This feasibility study is part of the research project in developing Stepping On after Stroke (SOS) falls prevention program for community stroke survivors in Singapore, which aims to reduce their fall rate and increase community participation. Prior to this study, systematic review was conducted to identify the fall risk factors in community stroke survivors, followed by a series of qualitative studies to seek input from various stakeholders to determine the key elements of the SOS program. Thereafter, this new program will be piloted in two day rehabilitation centers (DRC). Pre-post design and prospective observational method will be used in this study, where 12-16 stroke clients, 12-16 family members and 12-16 domestic helpers will be recruited from two DRCs. This program will consist of 2-hour weekly session led by a trained Stepping On after Stroke program leader for 7 weeks; two educational sessions for family members and helpers; supervised community mobility practices in a small group; a post-intervention home visit and 3-month booster session. Stroke participants will be followed up for 6 months after week 7. Monthly fall calendar will be used to collect fall incidents during the study. Findings from pre-post outcome measures on stroke participants’ physical mobility, fall related self-efficacy, fall risk behavior, and community participation will be collected. The caregiver’s self-assessment of health and quality of life will be collected from the family and helpers before and after the program. Data will be analyzed to determine if the proposed measurement tools are culturally applicable and sensitive in detecting the changes in respective functions among participants. Program evaluation survey will be conducted with the participants and program leaders to find out their perspective of the usefulness and applicability of the program. All findings from the feasibility study will assist in further refining the program for a larger effectiveness trial.

Interventions

Study period: November 2016 – July 2017 * Subject recruitment will start only when IRB approves. * Intervention will be from November 2016 to January 2017. * Follow up period will be from January 2017 to July 2017. Clinic sites for conducting this study: 1. Wellness Center, Alexandra Health System (Singapore) 2. SPD Day Rehabilitation Center (Singapore) Stepping On leader training workshop This is a 1.5-day face-to-face group-based training workshop conducted by master trainer Mr Xu Tianma

Study period: November 2016 – July 2017 * Subject recruitment will start only when IRB approves. * Intervention will be from November 2016 to January 2017. * Follow up period will be from January 2017 to July 2017. Clinic sites for conducting this study: 1. Wellness Center, Alexandra Health System (Singapore) 2. SPD Day Rehabilitation Center (Singapore) Stepping On leader training workshop This is a 1.5-day face-to-face group-based training workshop conducted by master trainer Mr Xu Tianma (Principal Investigator)(PI) for allied health professionals in Singapore to become qualified Stepping On program leaders. It provides them with the basic knowledge of Stepping on program in preparation for setting up the group based Stepping On programs for community older adults. The participant will learn the key elements of the program and basic skills in facilitating the groups by participating in role play sessions during the workshop in a classroom setting. Ankle weights will be used to demonstrate the upgrading of exercises during the role play sessions. Stepping On after Stroke leader training workshop This is an add-on training workshop to any Stepping On leaders who have completed the 1.5 days Stepping On leader training. It will be a face-to-face group-based training by master trainer Xu. Additional components to Stepping On program will be shared at the half day workshop. Role play will be conducted by trainees and facilitated by the master trainer. No other physical equipment will be needed except ankle weights for muscle strengthening exercises during the workshop. About master trainer The Stepping On leader training workshops are facilitated by Mr Xu Tianma who is the PI for this research project. Mr Xu is an occupational therapist (OT) with more than 15 years of clinical experience working with older adults and stroke population. He teaches the OT degree program in Singapore Institute of Technology. He has conducted many training sessions to healthcare professionals in the areas of falls prevention, and stroke rehabilitation. He has successfully conducted two Stepping On Leader Training Workshops in March and April 2016. Mr Xu is currently pursuing his PhD study with University of Sydney under Professor Lindy Clemson, the main author of Stepping On program. Staff involved: Stepping On after Stroke program leaders At least one OT and/or one physiotherapist(PT) from the participating rehabilitation center who have successfully completed the Stepping On facilitator training will be invited to join the half-day Stepping on after Stroke program leader training workshop. They will become Stepping On after Stroke program leaders in facilitating the program during the study. Onsite clinical coordinators There will be at least one therapist from each participating center to be appointed as onsite clinical coordinator to coordinate the participant recruitment and weekly sessions. Invited guest speakers External eye specialist and pharmacist will be invited as guest speakers to give a short session to stroke participants on common eye conditions in people after stroke in week 5 and medications and falls after stroke in week 6 respectively. The estimated time allocated for each expert will be 30 - 45 minutes. Program outline Pre-intervention evaluation will be conducted by the trained assessors at baseline using the series of standardized outcome measures. Each assessment session will last about one hour for each participant. 7 weeks intervention -Weekly session will be scheduled on weekdays at a comfortable time slot that suits the participants and the center. -Each group session will be run in an enclosed environment. -There will be one 2-hourly group session facilitated by a qualified Stepping On after Stroke program leader in each week for 7 weeks. -Each session consists of 20-30 minutes balance and strengthening exercises led by physiotherapist and facilitator. -Domestic helpers or caregivers are encouraged to join the weekly session with the stroke participants. -Each participant will receive one additional supervised community mobility practice session in a smaller group on top of the big group outing in week 5. -Each participant will be provided with weekly program handouts and a communication booklet and weekly homework sheet at each session. -The homework sheet will include Balance exercises & Strengthening exercises that each participant needs to tick daily once completed. Two additional educational sessions will be conducted for family members and domestic helpers in the 1st and 7th week. Each educational session will last for 2 hours. OT will share the program overview, nature of stroke, community resources, common falls prevention strategies with all family members and helpers. OT will discuss with all participants about their supporting role in preventing their loved ones from falling in the community. Follow-up home visit OT will contact each participant to arrange for home visit 4-6 weeks after the 7th session. It aims to follow through of preventive strategies and assist with home modifications. Phone call will be a back-up option if home visit is not possible. All participants and program leaders will be invited to fill up the program evaluation survey form after the home visit. Post-intervention reevaluation -Same outcome measures will be conducted after the home visit. -All participants and program leaders will be invited to fill up the program evaluation survey form after the home visit. 3-month booster session -All participants will be invited to join the 2-hour booster group session at 3 months after 7th session. -Facilitator and PT will review and conduct group exercise for 20 minutes. -During the session, every stroke participant and family members or helper will share with each other how they benefited from the program, such as their self-coping and falls prevention strategies, as well as challenges faced since the completion of the 7 weeks program. -Program evaluation survey will be issued to all participants again for their feedback after the booster session. 6-month follow-up -All stroke participants will be followed up for a period of 6 months after 7th session. -Each participant will be asked to keep track of their fall incidents (if any) during the 7 weeks program and 6 months after the 7th session. -Each participant will be asked to fill up the monthly fall calendar provided by the researcher and submit it to the onsite clinical coordinator or the researcher at the beginning of the following month. Family members and helpers will be encouraged to assist the stroke participant in this activity. Researchers will remind them by phone call if the monthly fall calendar is not returned on time. Fidelity check The PI Xu will conduct the fidelity check in week 3-5 to ensure the interventions are carried out as planned. Feedback will be given to the program leaders in each center after each fidelity check.

Sponsors

Xu Tianma
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria for stroke participant: * Age 50 and above * Diagnosed with stroke (first or recurrent stroke) within two years * Medically stable * Able to walk minimum 10 meters unsupported with or without aid * Has concerns about falling or had a history of fall * Able to communicate verbally in conversational English or Mandarin * Cognitively intact (Abbreviated Mental Test: 8 and above) * Able to make decision and give consent * Stays with a caregiver (either family member or domestic helper) Inclusion criteria for family member and domestic helper * Family member and domestic helper of the enrolled stroke participant * Able to understand and speak conversational English or Mandarin * Give consent * The age limit for family members and domestic helpers will be 18 and above.

Exclusion criteria

Exclusion criteria for stroke participants: * Unable to express verbally or understand verbal instructions * Cognitively impaired (AMT<8) * Wheelchair bound or bed bound * Medically unstable, e.g. unstable angina, untreated fits.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026