Home based, tailored intervention to reduce rate of falls after stroke (FAST): randomised trial.
Clemson L, Scrivener K, Lannin N, Ada L, Day S, Lin I, Isbel S, Cusick A, Gardner B, Preston E, Heller G, Dean CM, FAST Study Group
- DOI
- 10.1136/bmj-2025-085519
- Record issued
- 2026-08-10
- Engine
- 7.29.0
- Exported
- 2026-09-21
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/d9003ef9-5cdf-4446-bbde-6f94229b0434 is authoritative.
How this rating was calculated
- ReportingBiological variables partially met−0.25★
- ReportingEthical approvals partially met−0.25★
This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
This is a methodologically strong phase 3 RCT with rigorous randomisation, masking, power analysis, trial registration, CONSORT reporting, and a concrete data/code deposit. The main weaknesses are reporting gaps: absent explicit informed-consent and regulatory-compliance statements, missing race/ethnicity and weight/BMI baseline data, and an apparent DOI copy-paste error in the data availability statement.
Two independent reviewer runs agreed on all but biological variables (warn vs pass — resolved to warn given the concrete absence of standard demographic/baseline items); copyedit flagged 8 issues (1 major: a likely wrong DOI). Statistics verification recomputed only 4 of the paper's tests (those with test statistic+df or effect+CI); the remaining analyses are unverified, not confirmed. Citation check found no retracted or unlocatable references. The paper was evaluated on full text (published article).
Numerical inconsistencies
None foundValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
Checked — nothing surfaced.
Recomputed 4 tests: 4 consistent, 0 inconsistent; 2 recomputed directly from the reported test statistics, 2 via agent-written checks.
- CONSISTENTreported p = .020 · recomputed p = .020Recomputed incidence rate ratio 0.67 (95% CI 0.48–0.94), reported p=0.02
“incidence rate ratio 0.67, 95% confidence interval (CI) 0.48 to 0.94; P=0.02”
Taken as given: 0.48–0.94 is a two-sided 95% confidence interval for the incidence rate ratio of 0.67, not a range, an IQR, or a different interval level; the incidence rate ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.02 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.67, 0.48, 0.94, 1) - CONSISTENTreported p = .520 · recomputed p = .487Recomputed relative risk 0.94 (95% CI 0.79–1.12), reported p=0.52
“relative risk 0.94, 95% CI 0.79 to 1.12; P=0.52”
Taken as given: 0.79–1.12 is a two-sided 95% confidence interval for the relative risk of 0.94, not a range, an IQR, or a different interval level; the relative risk is a RATIO measure, so the interval is symmetric on the log scale; p=0.52 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.94, 0.79, 1.12, 1) - CONSISTENTreported p = .520 · recomputed p = .518Reviewer 2χ² test for proportion of fallers from 2x2 table (experimental 104/186, control 109/184)
“No (%) of fallers: Experimental 104 (56), Control 109 (59); RR 0.94 (0.79 to 1.12; 0.52)”
Taken as given: The cell counts are: exp events=104, exp non-events=82, con events=109, con non-events=75; The test is Pearson's χ² with 1 dfMethod: Pearson's χ² from 2x2 table.How we recomputed it: pChi2x2(104, 82, 109, 75) - CONSISTENTreported p = .020 · recomputed p = .019Reviewer 2Secondary outcome: LLFDI disability limitation at month 12, mean difference 3 (95% CI 1 to 6), P=0.02
“LLFDI disability (limitation) (0-100): mean difference 3 (1 to 6; 0.02)”
Taken as given: The CI is two-sided at 95%; The estimate is the mean difference (continuous, not log-transformed)Method: p from CI for a continuous estimate.How we recomputed it: pCI(3, 1, 6, 0)
Overstated conclusions
None foundConclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.
Checked — nothing surfaced.
6 major claims checked against the paper's own evidence: all adequately supported.
- supportedReviewer 1The intervention reduced the rate of falls by 33%.The primary outcome analysis shows a statistically significant 33% reduction (IRR 0.67, 95% CI 0.48 to 0.94, P=0.02), directly supporting the claim.Evidence: Table 2 and text: IRR 0.67 (0.48 to 0.94; P=0.02).
“a 33% reduction in falls (incidence rate ratio 0.67, 95% confidence interval (CI) 0.48 to 0.94; P=0.02)”
AbstractFind in source - supportedReviewer 1The intervention improved community participation, self-efficacy, mobility, and balance.Secondary outcomes at 12 months show statistically significant improvements in these domains with 95% CIs, supporting the claim.Evidence: Table 3 and text: LLFDI disability limitation 3% (1% to 6%); self-efficacy 0.6 (0.2 to 1.0); fast walking speed 0.13 m/s (0.06 to 0.19); Step Test 0.06 steps/s (0.01 to 0.12).
The main between group differences in favour of the experimental group were in community participation... self-efficacy... mobility... balance
Table 3reviewer’s wording - supportedReviewers 1, 2FAST is the first effectiveness trial to show prevention of falls after stroke.The paper states that three prior randomised trials found no effect, and this trial found a significant reduction, supporting the claim of being the first effective trial.Evidence: Discussion, Comparison with other studies: 'Only three previous randomised trials... all found no effect, making ours the first effectiveness trial to find a reduction.'
“FAST is the first effectiveness trial to show prevention of falls after stroke.”
DiscussionFind in source - supportedReviewer 2A tailored intervention prevented falls in community dwelling, ambulatory people with stroke.The primary outcome shows a significant 33% reduction in fall rate (IRR 0.67, 95% CI 0.48 to 0.94, P=0.02), supporting the claim.Evidence: Table 2: IRR 0.67 (0.48 to 0.94; 0.02)
“A tailored intervention prevented falls in community dwelling, ambulatory people with stroke.”
ConclusionFind in source - supportedReviewer 2The decrease in the rate of falls was underpinned by clinically worthwhile improvements in self-efficacy, mobility, community participation, and balance.Secondary outcomes show significant improvements in these domains (e.g., self-efficacy mean difference 0.6, 95% CI 0.2 to 1.0, P=0.004; fast walking speed 0.13 m/s, P<0.001). The claim is reasonable.Evidence: Table 3: self-efficacy, mobility, balance, community participation all show significant between-group differences at month 12.
“The decrease in the rate of falls was underpinned by clinically worthwhile improvements in self-efficacy, mobility, community participation, and balance.”
ConclusionFind in source - supportedReviewer 2The intervention can substantially prevent falls in community dwelling people after stroke.The primary outcome supports this claim, with a 33% reduction in fall rate. The word 'substantially' is justified by the effect size.Evidence: Primary outcome: IRR 0.67 (95% CI 0.48 to 0.94).
“A home based, tailored intervention (habit forming exercise, community mobility and safety training) can substantially prevent falls in community dwelling people after stroke”
What this study addsFind in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- ADEQUATESurrogate endpointPrimary endpoint is rate of falls, a hard clinical outcome.
“The primary outcome was rate of falls over 12 months.”
- ADEQUATEEffect size33% reduction in falls (IRR 0.67, 95% CI 0.48 to 0.94; P=0.02), described as clinically worthwhile.
“The decrease in the rate of falls was underpinned by clinically worthwhile improvements in self-efficacy, mobility, community participation, and balance.”
Data authenticity concerns
None foundAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
Checked — nothing surfaced.
Reporting gaps
2 findings · worst mediumRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
- Biological variables underreported (sex, age, strain)Assessed
- Ethics/consent reporting incompleteAssessed
Prior work is cited (three prior ineffective trials) with acknowledgment of their weaknesses (exercise segregated from daily activities, home modifications not targeting falls risk). The rationale for combining habit-forming exercise, home safety, and community mobility is logically linked to the premise. Limitations of prior research are addressed by integrating exercise into daily activities and tailoring to disability level.
“In three randomised trials, the non-drug interventions investigated to reduce falls after stroke were not effective and involved either home modifications or exercise that was segregated from daily activities.”
“The aim of this phase 3 randomised trial, therefore, was to determine the clinical effect of a multidisciplinary intervention to reduce falls.”
“The intervention combined exercise, home safety, and a community mobility goal, but most important is that the exercise is habit forming because it is integrated into daily activities.”
“In three randomised trials, the non-drug interventions investigated to reduce falls after stroke were not effective and involved either home modifications or exercise that was segregated from daily activities.”
“The intervention combined exercise, home safety, and a community mobility goal, but most important is that the exercise is habit forming because it is integrated into daily activities.”
Randomisation was performed by an offsite automated service with stratification and block randomisation. Blinding of outcome assessors and statistician was described; participants and therapists could not be blinded (open-label rationale). A priori power analysis was provided with effect size, alpha, power, and anticipated loss to follow-up. Pre-specified inclusion/exclusion criteria were detailed. Intention-to-treat analysis was used, addressing outlier handling per clinical trial norms.
“We used an offsite, independent, and automated service (Clinical Trials Centre, University of Sydney) to generate the sequence with stratification and block randomisation, to conceal the schedule from the recruiter, and to reveal allocation to the trial coordinators.”
“Assuming a 15% loss to follow-up, with a two sided level of significance of 5% and power of 80%, we needed a sample size of 185 per group to detect a 30% lower rate of falls in the experimental group than in the control group.”
“We used an offsite, independent, and automated service (Clinical Trials Centre, University of Sydney) to generate the sequence with stratification and block randomisation, to conceal the schedule from the recruiter, and to reveal allocation to the trial coordinators.”
“we needed a sample size of 185 per group to detect a 30% lower rate of falls in the experimental group than in the control group.”
Sex is reported in Table 1. Age is reported, but weight is not mentioned. Health status is partially captured by comorbidities and other measures. Demographics lack race/ethnicity, which is a standard reporting item for human studies. Since two of the three applicable sub-criteria are not fully reported, the dimension is rated warn.
“Female sex | 87 (47) | 82 (45)”
The paper states approval by Macquarie University Human Research Ethics Committee with two protocol numbers. However, no explicit statement that informed consent was obtained from participants (only that participants were capable of providing consent). Adherence to a recognised regulatory framework (e.g., Declaration of Helsinki) is not cited. These omissions are fixable reporting gaps rather than evidence of misconduct, so the dimension is rated warn.
“The study was approved by the Macquarie University Human Research Ethics Committee Human Research Ethics Committee (5201500456 and 520231547551507)”
The intervention consists of habit-forming exercise, home hazard reduction, and community mobility coaching. No investigational product, cell lines, antibodies, or other biological materials are involved. The only resources are standard therapy equipment and home adaptation items, which are not considered key biological/chemical resources per the criteria.
All statistical tests are named (negative binomial, χ², ANOVA, Mann-Whitney U). Assumptions are addressed through the use of appropriate models (negative binomial for overdispersion, ITT analysis). Exact p-values and 95% confidence intervals are reported for primary and secondary outcomes. Statistical software (R, SPSS) with versions is identified. Data are presented in tables with means, SDs, and group sizes. No arithmetic implausibilities were detected.
“IRR 0.67 (0.48 to 0.94; 0.02)”
“We used R version 4.4.2 to analyse falls data and IBM SPSS version 30 to analyse other secondary data.”
“We analysed the between group difference in annual rate of falls by using negative binomial regression”
“IRR 0.67 (0.48 to 0.94; 0.02)”
“We used R version 4.4.2 to analyse falls data and IBM SPSS version 30 to analyse other secondary data.”
The paper states that the statistical analysis plan, data, and analysis code files are lodged on the Sydney University eScholarship Repository with a handle URL. This qualifies as a concrete data availability statement with repository deposit. Code sharing is also covered. Sequencing data are not generated, so accession numbers are not applicable.
“The statistical analysis plan and the data and analysis code files using R statistical package version 4.4.2 and IBM SPSS version 30 are lodged on the Sydney University eScholarship Repository ( https://ses.library.usyd.edu.au/handle/2123/33822.3 ).”
“The statistical analysis plan and the data and analysis code files using R statistical package version 4.4.2 and IBM SPSS version 30 are lodged on the Sydney University eScholarship Repository ( https://ses.library.usyd.edu.au/handle/2123/33822.3 ).”
The trial is prospectively registered (ACTRN12619001114134). The CONSORT 2025 statement is referenced. All pre-specified outcomes are reported, including non-significant ones. Limitations are discussed (covid-19, therapist numbers, no patient involvement). Conclusions are proportional to the evidence. Funding source and competing interests are disclosed.
“Trial registration Australian New Zealand Clinical Trials Registry ACTRN12619001114134.”
“The study is reported in accordance with the updated CONSORT statement 2025.”
“The main limitation of the study is the large number of therapists needed to provide intervention across multiple sites and regions.”
“Trial registration Australian New Zealand Clinical Trials Registry ACTRN12619001114134.”
“The study is reported in accordance with the updated CONSORT statement 2025.”
“The main limitation of the study is the large number of therapists needed to provide intervention across multiple sites and regions.”
Registered (1 ID: ANZCTR). Reporting guideline cited: CONSORT.
Broken references and links
None foundReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
Checked — nothing surfaced.
Checked 31 references by DOI: 30 verified — 1 no DOI (shown, not verified).
- NO DOIEnvironmental interventions for preventing falls in older people living in the communityNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 data/code link checked; 0 live.
- datahttps://ses.library.usyd.edu.au/handle/2123/33822.3UNVERIFIEDHTTP 403Liveness indeterminate — content not checked.
Copyediting
1 finding · worst lowWording, consistency and formatting errors that need correcting before submission.
- Wording or formatting errors that need correctingAssessed
8 copyedit issues flagged (1 major): mostly typo, clarity, consistency.
- MAJORotherData availability statement“https://ses.library.usyd.edu.au/handle/2123/33822.3 (10.1136/bmj.g1687)”→ Verify the DOI; 10.1136/bmj.g1687 appears to be a different paper.The DOI appended to the repository URL may be a copy-paste error.
- MINORtypoEthics statements“Macquarie University Human Research Ethics Committee Human Research Ethics Committee”→ Remove duplicate 'Human Research Ethics Committee'The committee name is repeated.
- MINORclarityTitle line“Clemson Lindy professor emeritus Scrivener Katharine associate professor”→ Format as a standard author list: 'Clemson L, Scrivener K, et al.' with affiliations listed separately.The title line includes job titles, which is unconventional.
- MINORconsistencyMethods, Procedures“Physiotherapist and occupational therapist dyadic teams worked collaboratively”→ Physiotherapist and occupational therapist dyads worked collaborativelyThe phrase 'dyadic teams' is redundant.
- MINORtypoAbstract“Accepted 2026 Feb 9; Collection date 2026”→ Accepted 9 February 2026; Collection date 2026Inconsistent date format.
- MINORclarityResults, paragraph 1“Two thirds of participants were faster walkers and <10% were slower walkers.”→ Two-thirds of participants were faster walkers, and <10% were slower walkers.Missing hyphen in 'two-thirds' and comma.
- MINORconsistencyEthics statements“Macquarie University Human Research Ethics Committee Human Research Ethics Committee”→ Macquarie University Human Research Ethics CommitteeDuplicate phrase.
- MINORgrammarMethods, Procedures“an occupational therapist/physiotherapist dyad delivered the home based, tailored intervention”→ An occupational therapist/physiotherapist dyad delivered the home-based, tailored interventionCapitalization and hyphenation.
Post-publication audit: the published trial is robust in design, reporting, and statistical presentation, and no retracted citations or arithmetic errors were found; the primary result (IRR 0.67, 95% CI 0.48–0.94) is consistent with the recomputed checks. An informed reader should weigh the reporting gaps as minor: confirm the corrected repository DOI, and note that no explicit informed-consent/Helsinki statements and no race/ethnicity or weight baseline data are given. None of these warrant an erratum for scientific content, but the wrong DOI in the data availability statement does warrant a correction, and the consent/regulatory statements are worth adding if the publisher allows post-publication amendments.
- 1.HIGHdata codeVerify the DOI '10.1136/bmj.g1687' appended to the repository URL in the Data availability statement; it appears to reference a different paper — replace it with the correct DOI for this trial or remove it.A wrong DOI in the data availability statement misroutes readers and, in a post-publication context, is a concrete factual error that warrants a correction.
- 2.HIGHethicsAdd an explicit informed-consent statement (e.g., 'All participants provided written informed consent') to the Ethics statements section.The paper only states participants were 'capable of providing consent' as an inclusion criterion; an explicit consent statement is a standard and expected reporting element for a human trial.
- 3.MEDIUMethicsAdd a statement of regulatory compliance (e.g., 'conducted in accordance with the Declaration of Helsinki') to the Ethics statements section.Declaring adherence to a recognised regulatory framework is standard for human-subjects research and currently absent.
- 4.MEDIUMrigorReport race/ethnicity of participants in Table 1 baseline characteristics.Race/ethnicity is a standard demographic reporting item for human studies and its absence leaves demographic characterisation incomplete.
- 5.MEDIUMrigorReport participants' weight (or BMI) in Table 1 baseline characteristics.Weight/BMI is a routine biological descriptor whose absence makes the age/weight/health sub-criterion incomplete.
- 6.MEDIUMstatisticsAdd a brief note in the Statistical analysis section on how missing falls follow-up data were handled in the negative binomial regression (e.g., offset by available follow-up time).Clarifying how partial follow-up was modelled strengthens confidence in the primary IRR estimate.
- 7.MEDIUMstatisticsAdd a brief statement in the Statistical analysis section on whether distributional assumptions (normality, equal variance) were checked or why the chosen methods are robust to violations.Reviewer 2 noted assumptions were not explicitly verified; a one-line justification would close this reporting gap.
- 8.MEDIUMstatisticsAdd a rationale for the negative binomial dispersion parameter (α=0.8) used in the power calculation.Justifying this key model assumption would make the power analysis more transparent.
- 9.MEDIUMreportingAdd a statement about patient and public involvement in the design or conduct of the study, since its absence is acknowledged as a limitation.PPI reporting is an increasingly expected element and would offset the acknowledged gap.
- 10.LOWcopyeditFix the duplicate committee name in the Ethics statements: 'Macquarie University Human Research Ethics Committee Human Research Ethics Committee' → 'Macquarie University Human Research Ethics Committee'.The committee name is repeated; a clean copyedit item.
- 11.LOWcopyeditFormat the title line author list (currently includes job titles such as 'professor emeritus' and 'associate professor') as a standard author list with affiliations listed separately.Unconventional title formatting is a copyedit clarity issue.
- 12.LOWcopyeditFix minor copyedit items: hyphenate 'two-thirds' in Results paragraph 1; change 'dyadic teams' to 'dyads' in Methods/Procedures; standardise the Abstract date format ('Accepted 2026 Feb 9' → 'Accepted 9 February 2026'); capitalise/hyphenate 'home-based' in Methods/Procedures.These are small polish items that improve readability and consistency.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.
Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.