Stroke, IschemicNCT06577662
Effects of an Individual and Family Self-Management of Fall Prevention Program on Balance Ability and Fall-related Self-efficacy Among Chinese Post-Stroke Individuals
A study testing individual and family self-management (IFSM) fall prevention program in people with Stroke, Ischemic and Self Efficacy, run by Chiang Mai University at 1 site in China.
Trial summary
This study is about exploring the effectiveness of individual and family self-management (IFSM) fall prevention programs on balance ability and fall-related self-efficacy in post-stroke people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Self Efficacy, Fall
- What is being tested?
- individual and family self-management (IFSM) fall prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For patients
- aged 18 years or above;
- first-ever diagnosed with ischemic stroke;
- level of impairment assessed by the National Institutes of Health Stroke Scale (NIHSS) scores between 5 to 15 (moderate severity) before entering the experiment;
- mental state assessed by Mini-Mental State Exam score > 24;
- mobility tested by Timed Up and Go ≥12.6 second (walkers or another kinds of gait aid are allowed to be used in the test);
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- motor power of all limbs examined by muscle power assessment grade ≥3;
- ability to understand Chinese;
- living with family members;
- having phones that can use the internet;
- willing to join the study.
- For caregivers
- mental state assessed by Short Portable Mental Status Questionnaire score ≥8;
- being the primary caregiver, living in the same house, and taking care of the patient;
- having phones that can use the internet;
- can speak, understand, and write in Chinese; and (e) willing to participate.
Who cannot join
- having problems with sensory and/or global aphasia
- Discontinuation criteria:
- patients have an illness that needs hospitalization;
- patients and caregivers cannot complete participation in intervention sessions.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
About this study
This study is about exploring the effectiveness of individual and family self-management (IFSM) fall prevention programs on balance ability and fall-related self-efficacy in post-stroke people. The main intervention measures were developed based on the risk and protective factors of fall prevention in post-stroke people, including exercise, environment safety, assistant technology, medication review, and safety in daily activities. The intervention was implemented in 10 weeks for both patients and their family members. By mastering these skills, post-stroke people may reduce the number of falls after discharge to home.
- Conditions
- Stroke, Ischemic, Self Efficacy, Fall
- Being tested
- individual and family self-management (IFSM) fall prevention program
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual and family self-management (IFSM) fall prevention programBehavioural
The IFSM program will last for ten weeks, two weeks in the hospital, and follow up at eight weeks after patients discharge to home. It will include 11 sessions, including ten sessions developed in the inpatient department within two weeks and one online booster session developed in the first month (week 4) after discharge in home. There will be also one session just for caregivers.
Session 1 : PRST combined with GRI (one) Session 2 : Environment safety Session 3 : Assistant technology Session 4 : PRST combined with GRI (two) Session 5 : Medication review Session 6 : Safety in daily activities Session 7 : How to keep loved one safety Session 8 : Review of PRST combined with GRI Session 9 : Review of other five fall prevention skills Session 10 : Summary of the program and setting goals Session 11 : Booster session Week 10: Evaluation
| Study group | Role | What they receive |
|---|---|---|
| individual and family self-management (IFSM) fall prevention program | Experimental | The IFSM program will be last for ten weeks, two weeks in the hospital, and follow up at eight weeks after patients discharge to home. It includes 11 sessions, including ten sessions developed in the inpatient department within two weeks and one online booster session developed in the first month (week 4) after discharge in home. There will be also one session just for caregivers, which aims to improve caregivers' skills to keep patients' safety. In the process, self-efficacy strategies, self-regulation skills, and social facilitation are used in every session. The main self-efficacy strategies includes skill mastery, vicarious experience, and verbal persuasion. Several self-regulation skills for patients and caregivers are also used in the study, such as self-monitoring and reflective thinking. A WeChat group will be established to support patients and their families. Receives: Behavioral: individual and family self-management (IFSM) fall prevention program |
| usual care | No intervention | Participants in the control group will receive usual care, including standard clinical practices such as education on fall prevention and a fall prevention booklet. The education will be delivered by the researcher and does not include any additional intervention specific to the study. A fall prevention care plan will be manually documented in the electronic health record. After the patients are discharged home, a phone visit will be provided for patients within the first month, which will include a medication review and professional access. Participants will also use a fall record diary to record falls in the control group, and this will be copied for data extraction after the experiment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall-related self-efficacy
Fall-related self-efficacy refers to the level of perceived confidence in undertaking everyday activities without falling, which includes self-efficacy in balance ability, preventing falls, and managing falls. The Short Falls Efficacy Scale-International (Short FES-I) will be used to assess fall-related self-efficacy; it consists of seven questions. A four-point scale is used to score each item, and a higher score indicates lower self-efficacy. The total score is calculated by adding the scores of each item, giving a scale ranging from 7 to 28 for the seven items. The Short FES-I has previously demonstrated excellent reliability (Cronbach's α = 0.92).
Measured: Fall-related self-efficacy will be measured before the fall prevention program and after patients are discharged in 8 weeks.
Balance ability
Balance ability is the ability to maintain the body's stability, including keeping a certain posture or balance when subjected to external forces. Berg Balance Scale (BBS) will be used to assess the balance ability in post-stroke people. The BBS will be used to assess balance ability in post-stroke individuals. It consists of 14 items, each rated on a five-point scale. A score of 41-56 indicates the ability to walk independently, 21-40 indicates the ability to walk with assistance, and 0-20 indicates wheelchair-bound movement. In different studies on patients with stroke, the BBS has been found to have excellent internal consistency, with Cronbach alphas ranging from 0.92 to 0.98
Measured: Balance ability will be measured before the fall prevention program and after patients are discharged in 8 weeks.
Secondary outcomes (1)
Number of falls, fall-related injuries and Adverse Events
Measured: Number of falls and fall-related injuries will be measured after patients are discharged in 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Oct 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University
- Responsible party
- Principal investigator, Wang Yinhua, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577662
- Sponsor's protocol ID
- 2567-FULL018
- Status last verified
- Jun 2025
- First submitted
- 27 Aug 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant-level data related to the primary and secondary outcomes
Publications
Wang Y, Chaiard J, Lirtmunlikaporn S, Suwankruhasn N. Effects of an individual and family self-management of fall prevention programme on balance ability and fall-related self-efficacy among Chinese poststroke individuals: a study protocol for a randomised controlled trial. BMJ Open. 2025 Jul 15;15(7):e100966. doi: 10.1136/bmjopen-2025-100966.
PubMed 40664404
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Individual and Family Self-Management of Fall Prevention Program on Balance Ability and Fall-related Self-efficacy Among Chinese Post-Stroke Individuals
- ClinicalTrials.gov ID
- NCT06577662
- Acronym / sponsor ID
- 2567-FULL018
- Conditions
- Stroke, Ischemic, Self Efficacy, Fall
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is about exploring the effectiveness of individual and family self-management (IFSM) fall prevention programs on balance ability and fall-related self-efficacy in post-stroke people. The main intervention measures were developed based on the risk and protective factors of fall prevention in post-stroke people, including exercise, environment safety, assistant technology, medication review, and safety in daily activities. The intervention was implemented in 10 weeks for both patients and their family members. By mastering these skills, post-stroke people may reduce the number of falls after discharge to home.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individual and family self-management (IFSM) fall prevention program | Experimental | Behavioral: individual and family self-management (IFSM) fall prevention programThe IFSM program will be last for ten weeks, two weeks in the hospital, and follow up at eight weeks after patients discharge to home. It includes 11 sessions, including ten sessions developed in the inpatient department within two weeks and one online booster session developed in the first month (week 4) after discharge in home. There will be also one session just for caregivers, which aims to improve caregivers' skills to keep patients' safety. In the process, self-efficacy strategies, self-regulation skills, and social facilitation are used in every session. The main self-efficacy strategies includes skill mastery, vicarious experience, and verbal persuasion. Several self-regulation skills for patients and caregivers are also used in the study, such as self-monitoring and reflective thinking. A WeChat group will be established to support patients and their families. |
| usual care | No intervention | –Participants in the control group will receive usual care, including standard clinical practices such as education on fall prevention and a fall prevention booklet. The education will be delivered by the researcher and does not include any additional intervention specific to the study. A fall prevention care plan will be manually documented in the electronic health record. After the patients are discharged home, a phone visit will be provided for patients within the first month, which will include a medication review and professional access. Participants will also use a fall record diary to record falls in the control group, and this will be copied for data extraction after the experiment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- For patients
- For caregivers
Key exclusion criteria (4 listed)
- having problems with sensory and/or global aphasia
- patients have an illness that needs hospitalization;
- patients and caregivers cannot complete participation in intervention sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual and family self-management (IFSM) fall prevention programThe IFSM program will last for ten weeks, two weeks in the hospital, and follow up at eight weeks after patients discharge to home. It will include 11 sessions, including ten sessions developed in the inpatient department within two weeks and one online booster session developed in the first month (week 4) after discharge in home. There will be also one session just for caregivers. Session 1 : PRST combined with GRI (one) Session 2 : Environment safety Session 3 : Assistant technology Session 4 : PRST combined with GRI (two) Session 5 : Medication review Session 6 : Safety in daily activities Session 7 : How to keep loved one safety Session 8 : Review of PRST combined with GRI Session 9 : Review of other five fall prevention skills Session 10 : Summary of the program and setting goals Session 11 : Booster session Week 10: Evaluation | Behavioural | individual and family self-management (IFSM) fall prevention program |
Primary outcome
Fall-related self-efficacy
Time frame: Fall-related self-efficacy will be measured before the fall prevention program and after patients are discharged in 8 weeks.
Fall-related self-efficacy refers to the level of perceived confidence in undertaking everyday activities without falling, which includes self-efficacy in balance ability, preventing falls, and managing falls. The Short Falls Efficacy Scale-International (Short FES-I) will be used to assess fall-related self-efficacy; it consists of seven questions. A four-point scale is used to score each item, and a higher score indicates lower self-efficacy. The total score is calculated by adding the scores of each item, giving a scale ranging from 7 to 28 for the seven items. The Short FES-I has previously demonstrated excellent reliability (Cronbach's α = 0.92).
Balance ability
Time frame: Balance ability will be measured before the fall prevention program and after patients are discharged in 8 weeks.
Balance ability is the ability to maintain the body's stability, including keeping a certain posture or balance when subjected to external forces. Berg Balance Scale (BBS) will be used to assess the balance ability in post-stroke people. The BBS will be used to assess balance ability in post-stroke individuals. It consists of 14 items, each rated on a five-point scale. A score of 41-56 indicates the ability to walk independently, 21-40 indicates the ability to walk with assistance, and 0-20 indicates wheelchair-bound movement. In different studies on patients with stroke, the BBS has been found to have excellent internal consistency, with Cronbach alphas ranging from 0.92 to 0.98
1 secondary outcome
Number of falls, fall-related injuries and Adverse Events
Time frame: Number of falls and fall-related injuries will be measured after patients are discharged in 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Derived from this study: PubMed 40664404Wang Y, Chaiard J, Lirtmunlikaporn S, Suwankruhasn N. Effects of an individual and family self-management of fall prevention programme on balance ability and fall-related self-efficacy among Chinese poststroke individuals: a study protocol for a randomised controlled trial. BMJ Open. 2025 Jul 15;15(7):e100966. doi: 10.1136/bmjopen-2025-100966.
- Individual participant dataSharing planned: Yes. De-identified individual participant-level data related to the primary and secondary outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual and family self-management (IFSM) fall prevention program in people with Stroke, Ischemic and Self Efficacy, run by Chiang Mai University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall-related self-efficacy (time frame: Fall-related self-efficacy will be measured before the fall prevention program and after patients are discharged in 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06577662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.