Effects of a Home-Based Foot–Ankle Exercise Program with Educational Booklet for Foot Dysfunctions in People with Diabetic Neuropathy: Results of the FOCA-II Randomized Controlled Clinical Trial

Round 1

Reviewer 1 Report

I would like to thank the authors very much for addressing this interesting topic. Any work that strives to find more effective rehabilitation is a step toward the evidence-based rehabilitation so desperately needed.

 

I have no major comments. The work is very interesting, thoughtful and well presented. Although the results are not to the authors' liking, I think they could inspire others and be an interesting starting point for further research. I appreciate the authors' efforts on very detailed feedback and clear presentation of the results.

 

Author Response

Please see the attachment.

Author Response File: Author Response.docx

Reviewer 2 Report

94 As reported by the Authors, glycated hemoglobin and blood glucose control were not evaluated and may have influenced diabetic peripheral neuropathy (DPN) related outcomes.

100. Does the exclusion criterion (# 6), for patients who received physiotherapy or offloading devices during the surgery period, include orthotic Insoles or orthopedic shoes, too?

137-138. It needs to be clarified how the researcher verified the actual and proper performance of home-based self-physiotherapy sessions.

154-161 Indicate literature validating the reliability of Multimask software v.9.35

197 Table1 On vibration perception, there is relevant difference between group with intervention (IC) compared with control group CG). Vibration is absent in 20 participants (80%) in the CI compared versus 13 participants (60%) in the CG. Reduced vibration in 8 participants (32%) in the CI compared versus 14 participants (56%) in the CG.

329 How was "good adherence among participants (72%)" verified?

347 "As the intervention showed good adherence (72%)". It needs to be better clarified.

352 The conclusions differ from those of other research cited by the Authors and from that of Iram’s RCT (non-randomized control group trial).¹  The Authors should report a comparative analysis between the pro-physiotherapy work (in favor of) and the different conclusions of their research.

362 Since some public Institutions (*) funded the research, it is suggested that the economic impact of home-based physiotherapy versus face-to-face (in-person) physiotherapy be clarified. Including the cost of remote supervision.

(*) National Council for Scientific and Technological Development, Brazil (CNPq); Agency Coordination of Improvement of Higher Education Personnel (CAPES; Sao Paulo Research Foundation (FAPESP)

386 References. Twenty-one (21) out of 54 manuscripts were published more than a decade ago. Are they essential to support what is reported in the text? Haven't the Authors of those manuscripts published anything more recent? The following manuscript is missing:

¹ Iram H, Kashif M, Junaid Hassan HM, Bunyad S, Asghar S. Effects of proprioception training programme on balance among patients with diabetic neuropathy: A quasi-experimental trial. J Pak Med Assoc. 2021 Jul;71(7):1818-1821. doi: 10.47391/JPMA.286. PMID: 34410254.

Author Response

Please see the attachment.

Author Response File: Author Response.docx

Reviewer 3 Report

Reviewer Comments

Thank you very much for the opportunity to review the manuscript submission entitled: Effects of a home-based foot-ankle exercise program with educational booklet for foot dysfunctions in people with diabetic neuropathy: results of the foca-ii randomized controlled clinical trial.

The purpose of this randomized controlled trial was to investigate the effect of an 8-week home-based foot-ankle exercise program using an educational booklet on clinical outcomes and gait biomechanics. The data is interesting and it has a relevant rationale, however, some limitations and constructive comments are pointed below:

Specific comments

Title and Abstract

·       Include mean age of the participants in the abstract

·       Clearly mention the clinical outcomes and gait biomechanics outcomes?

·       Include MeSH terms as keywords

Introduction

·       Need more explanation on the scientific background and rationale for the investigation being reported.

·       Include hypothesis of the study

 Methods

·       Do not use “CG” for control group. Please mention it as control group. Make changes throughout the manuscript.

·       Clearly explain about the Allocation concealment

·       Why the design was did not considered subjects and investigators ‘blinding’ about treatment allocation. Explain? I did not see the explanation in the limitations section also.

·       How well was the study done to minimize bias? Describe any efforts to address potential sources of bias

Results

·       The study should report any important differences in the composition of the study groups with regard to characteristics that could affect response to the intervention being investigated. Include p-values for differences between the groups in table 1.

Discussion:

·       Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias.

·       Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence

·       Discuss the generalizability (external validity) of the study results

 

 

Author Response

Please see the attachment.

Author Response File: Author Response.docx

Round 2

Reviewer 3 Report

The authors have addressed all my comments. The manuscript can be accepted in its current form.