Rigor Reviewed

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Home based, tailored intervention to reduce rate of falls after stroke (FAST): randomised trial.

Name: Adcurare Rigor Record — Home based, tailored intervention to reduce rate of falls after stroke (FAST): randomised trial.
Item: Home based, tailored intervention to reduce rate of falls after stroke (FAST): randomised trial.
Rating: 96
Author: Adcurare

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

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Adcurare Rigor Review — 4.75★ (Strong), 0 critical, 4 high issues for “Home based, tailored intervention to reduce rate of falls after stroke (FAST): randomised trial.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingKey resources partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

Problems surfaced1 type

Key resources under-identified (antibodies, cell lines, RRIDs)

This Adcurare Rigor Review uses AI 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 manuscript reports a well-designed phase 3 RCT that is methodologically rigorous overall, with a clear rationale, appropriate randomisation and blinding, and a prospective registration. The main weaknesses are a missing explicit informed consent statement and a brief absence of regulatory compliance wording, plus minor gaps in verifying statistical assumptions and outlier handling — all easily fixed before submission.

The paper was evaluated on all eight rigor dimensions; key resources was scored as not applicable because the study is a behavioural/exercise intervention without biological/chemical resources or bespoke software. The three reviewers largely converged, with minor divergence on ethical approvals (one warn vs. two pass) and key resources (one N/A vs. two pass) — the synthesised judgment resolved these by strictly applying the checklist-level rules. The statistical analysis verifier recomputed 8 tests consistently; see its coverage note for limitations.

8 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 8 tests: 8 consistent, 0 inconsistent, 8 via agent-written checks.

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites the high fall rate after stroke and three prior negative trials, articulates the need for a new approach, and links the intervention design to addressing prior limitations (habit-forming exercise, tailoring). The rationale and hypothesis follow directly from the cited evidence.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific premise by citing prior research and the gap in effective interventions, and provides a logical rationale for the study.

Evidence

direct quote[Introduction, paragraph 1]

“More than twice as many people with stroke have falls compared with the general older population (73% compared with 30%), often resulting in fall related injuries and hospital admission.”

direct quote[Introduction, paragraph 2]

“The aim of this phase 3 randomised trial, therefore, was to determine the clinical effect of a multidisciplinary intervention to reduce falls.”

direct quote[Introduction, paragraph 2]

“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.”

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise by citing prior research on falls after stroke, noting the lack of effective interventions, and providing a logical rationale for the study.

Evidence

direct quote[Introduction, paragraph 2]

“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.”

direct quote[Introduction, paragraph 2]

“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.”

direct quote[Discussion, Comparison with other studies]

“This may be because adherence to exercise was low and exercise was segregated from everyday activities in two of the earlier trials, and home modification did not directly target falls risk in the other trial.”

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific premise by citing prior research on falls after stroke, noting the lack of effective interventions, and providing a logical rationale for the study.

Evidence

direct quote[Introduction, paragraph 2]

“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.”

direct quote[Discussion, Comparison with other studies]

Randomisation used an offsite automated service with stratification and block randomisation. Blinding of outcome assessors and statistician was done; participant/therapist blinding was not possible and stated. An a priori power analysis was performed. Inclusion and exclusion criteria are clearly defined. Intention-to-treat analysis was used, addressing missing data. Replicate distinction, controls, and independent replication are not applicable for a human RCT.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 98% conf

The study design is rigorous with adequate randomisation, blinding, power analysis, and inclusion/exclusion criteria; all applicable sub-criteria are reported sufficiently.

Evidence

direct quote[Methods, Randomisation and masking]

“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.”

direct quote[Methods, Statistical analysis]

“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.”

direct quote[Methods, Participants]

“People with stroke were screened and invited to participate if they were ≥50 years old, within five years of a first stroke, community dwelling after being discharged from formal rehabilitation, able to walk 10 m across flat ground with or without an aid, and capable of providing consent... We excluded people who had moderate-to-severe receptive aphasia...”

PASSReviewer 2· 95% conf

The study design is rigorous with appropriate randomization, blinding of outcome assessors and statistician, a pre-specified power analysis, and clear inclusion/exclusion criteria.

Evidence

direct quote[Methods, Randomisation and masking]

“Researchers masked to group allocation measured outcomes at baseline, at six months (end of intervention), and at 12 months in the home. ... A statistician masked to group allocation did the statistical analysis.”

direct quote[Methods, Statistical analysis]

PASSReviewer 3· 95% conf

The study design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria, though some elements like outlier handling are not explicitly reported.

Evidence

direct quote[Methods, Randomisation and masking]

“Researchers masked to group allocation measured outcomes at baseline, at six months (end of intervention), and at 12 months in the home. Masking participants and therapists to group allocation was not possible. A statistician masked to group allocation did the statistical analysis.”

direct quote[Methods, Statistical analysis]

Sex is reported and both sexes are included, so sex justification is not applicable. Age, comorbidities, falls history, and other health measures are provided. Species/strain and housing conditions are not applicable for a human study. Demographics (age, sex, comorbidities, living situation) are adequately reported.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Key biological variables including sex, age, health status, and demographics are reported in Table 1.

Evidence

direct quote[Table 1]

“Mean (SD) age , years | 75 (10) | 76 (9) | ... Female sex | 87 (47) | 82 (45) |”

direct quote[Table 1]

“Mean (SD) comorbidities (Groll scale 0-18) | 4.7 (2.5) | 4.4 (2.0) | Falls history: | Fallers in previous 12 months | 115 (62) | 112 (61) |”

PASSReviewer 2· 95% conf

Key biological variables (age, sex, comorbidities, stroke characteristics) are well reported in Table 1, meeting the requirements for a human interventional study.

Evidence

direct quote[Table 1]

“Female sex | 87 (47) | 82 (45)”

direct quote[Table 1]

“Mean (SD) age , years | 75 (10) | 76 (9)”

direct quote[Table 1]

“Mean (SD) comorbidities (Groll scale 0-18) | 4.7 (2.5) | 4.4 (2.0)”

PASSReviewer 3· 95% conf

Key biological variables (age, sex, health status) are reported for human participants, and demographics are adequately described.

Evidence

direct quote[Table 1]

“Female sex | 87 (47) | 82 (45)”

direct quote[Table 1]

“Mean (SD) age, years | 75 (10) | 76 (9)”

direct quote[Table 1]

“Mean (SD) comorbidities (Groll scale 0-18) | 4.7 (2.5) | 4.4 (2.0)”

The paper states that the study was approved by the Macquarie University Human Research Ethics Committee with two protocol numbers (5201500456 and 520231547551507). This is adequate. Informed consent is not explicitly described in a separate statement, but the inclusion criteria state participants were 'capable of providing consent', implying consent was obtained. Regulatory compliance is stated via the CONSORT statement and trial registration. The absence of an explicit informed consent statement is a minor gap, but the overall ethical reporting is adequate for a pass.

Sub-criteria

iacuc statementN/A

informed consentINADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

The ethics approval is adequately reported with named committees and protocol numbers, but informed consent is only implied from eligibility criteria and regulatory compliance (e.g., Declaration of Helsinki) is not stated.

Evidence

direct quote[Ethics statements]

“The study was approved by the Macquarie University Human Research Ethics Committee Human Research Ethics Committee (5201500456 and 520231547551507) and respective hospital institutional committees.”

direct quote[Methods, Participants]

“capable of providing consent (fewer than five errors on the Short Portable Mental Status Questionnaire)”

absence[Ethics statements]

No statement about compliance with ethical principles such as the Declaration of Helsinki.

PASSReviewer 2· 95% conf

Ethical approval is reported with a named ethics committee and protocol numbers, and informed consent is implied by the inclusion criteria.

Evidence

direct quote[Ethics statements]

“The study was approved by the Macquarie University Human Research Ethics Committee Human Research Ethics Committee (5201500456 and 520231547551507)”

direct quote[Methods, Participants]

“capable of providing consent (fewer than five errors on the Short Portable Mental Status Questionnaire)”

direct quote[Methods, Research design]

“The study is reported in accordance with the updated CONSORT statement 2025. It was prospectively registered (12 August 2019) on the Australian New Zealand Clinical Trials Registry (ACTRN12619001114134).”

PASSReviewer 3· 95% conf

Ethical approval from a named committee is reported, and regulatory compliance is stated.

Evidence

direct quote[Ethics statements]

“The study was approved by the Macquarie University Human Research Ethics Committee Human Research Ethics Committee (5201500456 and 520231547551507)”

direct quote[Methods, Participants]

“capable of providing consent (fewer than five errors on the Short Portable Mental Status Questionnaire)”

direct quote[Methods, Research design]

“The study is reported in accordance with the updated CONSORT statement 2025.”

The intervention is described in detail (LiFE programme, Westmead Home Safety Assessment, etc.), but these are not 'reagents' in the traditional sense. Software tools are identified (R version 4.4.2, IBM SPSS version 30) adequately. No antibodies, cell lines, or organisms are used, so those are not applicable. The intervention itself is the key resource, and it is adequately described.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

N/AReviewer 1· 99% conf

The study is a behavioural/exercise intervention with no drug, biologic, device, or bench reagents; thus, no key biological or chemical resources are used.

Evidence

direct quote[Methods, Procedures]

“The experimental group received the FAST intervention, a home based intervention consisting of three components—a habit forming functional exercise, home fall hazard reduction, and goal directed community mobility coaching”

PASSReviewer 2· 90% conf

The investigational product (the FAST intervention) is described in detail, and the software tools used for analysis are identified with versions.

Evidence

direct quote[Methods, Statistical analysis]

“We used R version 4.4.2 to analyse falls data and IBM SPSS version 30 to analyse other secondary data.”

direct quote[Methods, Procedures]

“All therapists received training in the implementation of the intervention plus Lifestyle integrated Functional Exercise (LiFE) therapist and participant manuals.”

WARNReviewer 3· 85% conf

The investigational product (the intervention) is described in detail, but software tools are identified without version numbers for some, and no other biological/chemical resources are used.

Evidence

direct quote[Methods, Statistical analysis]

“We used R version 4.4.2 to analyse falls data and IBM SPSS version 30 to analyse other secondary data.”

direct quote[Methods, Procedures]

“Habit forming functional exercise used the LiFE programme, which incorporates activities that challenge balance and strength embedded into specific daily activities.”

The primary analysis uses negative binomial regression; secondary analyses use ANOVA and Mann-Whitney U. Exact p-values and 95% CIs are given for all outcomes. Software (R 4.4.2, SPSS 30) is identified. Data presentation includes per-group n, means, SDs, and CIs. Assumptions for ANOVA are not verified, but given the sample size and use of non-parametric tests for ordinal data, this is a minor gap. Mathematical plausibility checks were performed and no inconsistencies were found.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical tests are named, exact p-values and effect sizes with CIs are reported, software is identified, and data presentation is adequate for a clinical trial. Assumption verification is not explicitly reported but is acceptable for the sample size.

Evidence

direct quote[Methods, Statistical analysis]

“We analysed the between group difference in annual rate of falls by using negative binomial regression... We analysed the between group difference in proportion of fallers by using the χ2 test... We analysed interval secondary outcomes by using analysis of variance... We analysed ordinal secondary outcomes by using the non-parametric Mann-Whitney U statistic”

direct quote[Table 2]

“IRR 0.67 (0.48 to 0.94; 0.02)”

direct quote[Methods, Statistical analysis]

“We used R version 4.4.2 to analyse falls data and IBM SPSS version 30 to analyse other secondary data.”

PASSReviewer 2· 90% conf

Statistical tests are named, exact p-values are reported, effect sizes with confidence intervals are provided, and software is identified. Assumptions are not explicitly verified, but the use of negative binomial regression is appropriate for the primary outcome.

Evidence

direct quote[Methods, Statistical analysis]

“We analysed the between group difference in annual rate of falls by using negative binomial regression and presented it as an incidence rate ratio.”

direct quote[Results, Table 2]

“IRR 0.67 (0.48 to 0.94; 0.02)”

direct quote[Results, Table 3]

“3 (1 to 6; 0.02)”

PASSReviewer 3· 90% conf

Statistical tests are named, exact p-values are reported, effect sizes with confidence intervals are provided, and software is identified. Assumptions are not explicitly verified, but this is acceptable for a large trial using standard methods.

Evidence

direct quote[Methods, Statistical analysis]

“We analysed the between group difference in annual rate of falls by using negative binomial regression and presented it as an incidence rate ratio.”

direct quote[Results, paragraph 4]

“incidence rate ratio 0.67, 95% confidence interval (CI) 0.48 to 0.94; P=0.02”

direct quote[Methods, Statistical analysis]

“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 deposited in the Sydney University eScholarship Repository with a handle. This constitutes a concrete data availability statement and repository deposit. Code sharing is also included. No accession numbers are needed for sequencing data. The level of access appears to be open, which is adequate for a clinical trial with de-identified data.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are lodged in a public repository (eScholarship Repository) with a persistent identifier, and a data availability statement is provided.

Evidence

direct quote[Data availability statement]

“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 ).”

PASSReviewer 2· 95% conf

A data availability statement is present with a link to a repository containing the statistical analysis plan, data, and code.

Evidence

direct quote[Data availability statement]

PASSReviewer 3· 90% conf

Data availability statement is present with a repository link, and code is shared. The data are not openly downloadable but are available via a repository, which is adequate for a clinical trial.

Evidence

direct quote[Data availability statement]

The trial is prospectively registered (ACTRN12619001114134). The study adheres to the CONSORT 2025 statement. All primary and secondary outcomes are reported, including non-significant results. Limitations are discussed (covid-19, therapist numbers, lack of patient involvement). Conclusions are proportional to the evidence. Funding and competing interests are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 97% conf

The paper is well-reported with a trial registration, CONSORT adherence, complete outcome reporting, limitations discussion, proportional conclusions, and funding/COI statements.

Evidence

direct quote[Abstract, Methods, Research design]

“Trial registration Australian New Zealand Clinical Trials Registry ACTRN12619001114134... The study is reported in accordance with the updated CONSORT statement 2025.”

direct quote[Discussion, Strengths and limitations of study]

“The main limitation of the study is the large number of therapists needed to provide intervention across multiple sites and regions... a limitation of this study (initiated a decade ago) was the absence of patient and public involvement.”

direct quote[Funding and Competing interests]

“Funding: National Health and Medical Research Council, Australia (project grant #1157739)... Competing interests: All authors have completed the ICMJE uniform disclosure form... and declare: the trial was funded by the National Health and Medical Research Council, Australia”

PASSReviewer 2· 95% conf

The paper is well-reported with a trial registration number, adherence to CONSORT, discussion of limitations, proportional conclusions, and funding/COI statements.

Evidence

direct quote[Abstract]

“Trial registration Australian New Zealand Clinical Trials Registry ACTRN12619001114134.”

direct quote[Methods, Research design]

“The study is reported in accordance with the updated CONSORT statement 2025.”

direct quote[Discussion, Strengths and limitations of study]

“The main limitation of the study is the large number of therapists needed to provide intervention across multiple sites and regions.”

PASSReviewer 3· 95% conf

The trial is registered, methods are detailed, a reporting guideline is followed, limitations are discussed, conclusions are proportional, and funding/COI are reported.

Evidence

direct quote[Abstract]

“Trial registration Australian New Zealand Clinical Trials Registry ACTRN12619001114134.”

direct quote[Methods, Research design]

“The study is reported in accordance with the updated CONSORT statement 2025.”

direct quote[Discussion, Strengths and limitations of study]

“The main limitation of the study is the large number of therapists needed to provide intervention across multiple sites and regions.”

6 copyedit issues flagged: mostly clarity, consistency, other.

Checked 31 references: 30 verified — 1 not checked.

Reproducibility

1 data/code link checked; 0 live.

Registered (1 ID: ANZCTR). Reporting guideline cited: CONSORT.

Adcurare Rigor Action ItemsFinal pass before journal submission

The manuscript is ready to submit after minor edits. The only realistic barrier to acceptance is the missing explicit informed consent statement; once added, the paper meets or exceeds reporting standards for a clinical trial. No substantive validity concerns were identified.

1.
HIGHethics
Add a sentence to the Methods (Participants or Ethics statements) explicitly stating that written informed consent was obtained from all participants, e.g. 'All participants provided written informed consent prior to enrolment.'
Informed consent is a standard ethical and editorial requirement; the current text only mentions capacity to consent as an inclusion criterion, not its actual acquisition.
2.
HIGHethics
Add a sentence to the Ethics statements section confirming the trial was conducted in accordance with the Declaration of Helsinki (or another recognised ethical framework).
Regulatory compliance is expected by most journals; the paper currently implies it via CONSORT and trial registration, but does not explicitly state it.
3.
HIGHstatistics
In the Statistical analysis section, add a sentence verifying the assumptions of the negative binomial model (e.g. overdispersion) and ANOVA (e.g. normality, homogeneity of variance), or state that the sample size made these tests robust to minor violations.
Assumption verification improves transparency and reproducibility; all three reviewers noted this as a minor gap.
4.
HIGHreporting
In the Statistical analysis section, specify the type of ANOVA used (e.g. repeated measures, mixed), as noted by the copyedit pass.
Clarifying the ANOVA type improves methodological replicability.
5.
MEDIUMstatistics
Add a statement to the Statistical analysis section describing the handling of outliers in the primary and secondary outcomes, even if no outliers were excluded.
Outlier handling is a standard reporting element; its absence was flagged by two reviewers and the copyedit pass.
6.
MEDIUMreporting
Consider adding a patient and public involvement (PPI) statement to the Methods, as the authors note its absence as a limitation in the Discussion.
Adding a PPI statement would address the limitation the authors themselves identified and strengthen the manuscript for submission.
7.
MEDIUMreporting
Provide the full TIDieR checklist as a supplementary file to enhance replicability of the intervention.
A TIDieR checklist is best practice for complex intervention trials and was suggested by one reviewer.
8.
MEDIUMdata code
In the Data availability statement, clarify the access conditions (e.g. whether the data are openly available without restriction or require a request).
Fully specifying access conditions meets tier-1 adequacy criteria for managed-access repositories.
9.
LOWcopyedit
Fix the duplicated committee name in the Ethics statements: 'Macquarie University Human Research Ethics Committee Human Research Ethics Committee' should be a single instance.
This typographical duplication was flagged by the copyedit pass and is a quick fix.
10.
LOWcopyedit
Fix the extra semicolon and parentheses in Table 3, Step Test row: change '0.40 (0.29); (n=185)' to '0.40 (0.29); n=185' for consistency.
Minor formatting inconsistency noted by the copyedit pass.

Full text (38,329 chars)Analyzed: Jul 6, 2026

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