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Active, Not Recruiting

NCT Number: NCT06577662

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Fall Ischemic Stroke Nervous System Diseases Self Efficacy Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • 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.

Exclusion criteria

for patients:

  • 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.

Treatment and study plan

individual and family self-management (IFSM) fall prevention program

Behavioral

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

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Collaborators

  • The Affiliated Hospital Of Guizhou Medical University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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