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Development and validation of a fall risk prediction model integrating objective gait metrics for patients with cerebral small vessel disease: protocol for a two-phase study

Year: 2026

Type: article

Abstract: Introduction Gait impairment in cerebral small vessel disease (CSVD) is often insidious in onset and constitutes a significant risk factor for falls, leading to severe health and economic consequences. Accurate prediction of fall risk in this population is critical for timely intervention. However, current clinical practice relies on subjective assessment scales (eg, the Morse Fall Scale), which are insensitive to the early, complex and heterogeneous gait abnormalities characteristic of CSVD, leading to under-detection of high-risk individuals until advanced stages. This protocol describes a planned study to develop and validate a novel, objective fall risk prediction model for patients with CSVD, leveraging quantitative gait analysis instruments to capture key kinematic parameters. Methods and analysis A two-phase study is planned. Phase 1 is a retrospective case-control study to develop the prediction model using data from an existing CSVD cohort, involving 240 fallers and 240 propensity score-matched non-fallers. Model development will employ multivariable logistic regression with stepwise variable selection guided by clinical relevance and internal validation via bootstrap resampling to correct for over-optimism. Phase 2 is a prospective cohort study for external validation. An independent cohort of 400 patients will undergo simultaneous baseline assessment with the novel model and the standard Morse Fall Scale, followed by 12 months of prospective fall monitoring. The model’s superiority will be evaluated by comparing the Area Under the ROC Curve (AUC), sensitivity and specificity against the standard scale, with the primary analysis focusing on AUC difference using DeLong’s test. Ethics and dissemination Ethical approval has been obtained from the Ethics Committee of Peking Union Medical College Hospital (No. I-25PJ04367). The findings will be disseminated through peer-reviewed publications and conference presentations. The study is scheduled to commence in May 2026 and is anticipated to be completed by November 2027. Study registration Chinese Clinical Trial Registry (ChiCTR2600116093).

Source: BMJ Open

DOI: 10.1136/bmjopen-2026-119421