PONE-D-21-39411Exploring the effects of technological visuo-cognitive training in Parkinson’s: Study protocol for a pilot randomised controlled trial.PLOS ONE

Dear Dr. Stuart,

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Partly

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Comments:

This small RCT addresses a gap in understanding and care and has the potential to contribute to the literature and body of knowledge in the field.

Some comments:

This is a feasibility pilot study to ‘provide preliminary data to support a larger, multi-centre randomised 46 controlled trial’. As such, the main outcomes (not primary, which should be reserved for a full scale efficacy/effectiveness trial) should be the feasibility/acceptability elements and the other efficacy outcomes (i.e. TMT) should be exploratory at best. Feasibility issues such as recruitment and attrition/retention should be included and at the forefront.

What is the rationale for the TMT as the main efficacy outcome?

Is this study addressing a priority area of research/clinical care stated by the Parkinson’s community? If so, it should be stated.

The rationale is ‘novel non-pharmacological rehabilitation strategy for prevention of falls in PwP’ but number and type of falls is not being measured. The overarching aim and outcomes need to be correctly aligned.

It is not clear why there is such an emphasis on the impact on visuo-cognitive function and falls? While this may certainly be an issue, the other functional impacts appear to be ignored – what about other ADLs, driving, using eating utensils, reading etc. The study is designed as a falls’ prevention program, yet the mechanism is broader, and the main outcome addresses visual attention (i.e. TMT) – this does not align correctly. The link between falls, visuo-cognition and visual attention need to be much better explained. The manuscript would benefit from a clearly thought through logic model.

The study compares two visuo-cognitive intervention groups (technological or standard); what is the rationale that one intervention will improve TMT more than the other? Surely the approaches differ only in mode of delivery/implementation rather than mechanism of action. Thus, the focus should be on adherence/acceptability/usability etc rather than a signal of change in cognitive outcome.

There are no cognition-based inclusion/exclusion criteria yet the main outcome, and indeed intervention, is visuo-cognition based. What about people with PD-MCI or parkinson’s plus syndromes?

What is the basis for the sample size? Has a power analysis been done?

What assessment will be done to ascertain probability of unblinding?

What is the rationale and evidence for the dose of the intervention (duration, frequency, number of weeks etc)?

Reviewer #2: This is a well-written, well-considered proposal for a pilot project. I think the protocol for persons with PD may be long but the authors have considered fatigue as a barrier. Perhaps specifying eye fatigue would be helpful as this is likely to occur in this population. I have no specific edits or recommendations beyond that and recommend accepting without revision.

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Reviewer #1: No

Reviewer #2: Yes: Lisa M Muratori, PT, EdD

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Exploring the feasibility of technological visuo-cognitive training in Parkinson’s: Study protocol for a pilot randomised controlled trial.

PONE-D-21-39411R1

Dear Dr. Stuart,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Walid Kamal Abdelbasset, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #2: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #2: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #2: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #2: No

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: No further comments. I accepted the manuscript previously and continue to believe the authors have a manuscript that is well-written and clear.

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #2: Yes: Lisa M Muratori

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