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Assessment of the Impact of the Tipstim^® Device Application and the Study Position on Motor Coordination and Grip Strength of the Affected Upper Limb Post-Ischemic Stroke—A Randomized Parallel Crossover Trial

Appl. Sci. 2022, 12(6), 2761; https://doi.org/10.3390/app12062761

by Anna Olczak^1,* and Aleksandra Truszczyńska-Baszak²

Reviewer 1:

Francesco Corea

Reviewer 2: Anonymous

Reviewer 3: Anonymous

Reviewer 4: Anonymous

Appl. Sci. 2022, 12(6), 2761; https://doi.org/10.3390/app12062761

Submission received: 13 January 2022 / Revised: 22 February 2022 / Accepted: 2 March 2022 / Published: 8 March 2022

(This article belongs to the Section Applied Neuroscience and Neural Engineering)

Round 1

Reviewer 1 Report

Even if in a small group of cases the study bring interesting data on the use of a specific device to support the recovery from an ischemic stroke. The design is appropriate and the procedure is described in detail.

TipStim is a registred trademark and needs (R) code in the title and body of the manuscript. Clarify potential conflict of interest or financial support from the industry.

Being a small population may be easier to offer to the reader more data regarding the index event:

1)Take into account that only two thing predict the recovery of a stroke first receiving time dependent therapy and second being admitted to a stroke unit. No data ara available concerning these to aspects. Did the case control study included subjects suffering of a stroke not treated with any disease modifying therapy ?

2)Please provide a table with a generic definition of infarction location (right/left, deep lacunar, cortical, brain stem).

Author Response

Manuscript ID: applsci-1576091

Type of manuscript: Article

Title (previous): Assessment of the impact of the TipStim device application and the study position on motor coordination and grip strength of the affected upper limb in patients after ischemic stroke - a randomized crossover trial.

Full title (after change): Assessment of the impact of the tipstim® device application and the study position on motor coordination and grip strength of the affected upper limb post-ischemic stroke - a randomized parallel crossover trial.

Dear Reviewers,

Thank you very much for the analysis of our manuscript. We really appreciate your comments and indication of fragments that should be corrected and explained. Considering your suggestions, all mistakes were corrected. In order to avoid misunderstandings, changes introduced in the text are marked in blue and additionally, the manuscript was sent in the change tracking mode.

Reviewer #1:

Thank you very much for the very quick and thorough analysis of our manuscript.

The following comments and answers:

Thank you very much for your appreciation for our manuscript.

TipStim is a registred trademark and needs (R) code in the title and body of the manuscript. Clarify potential conflict of interest or financial support from the industry.

Indeed, I made a mistake by not including the trademark and the code of needs (R) in the title and content of the manuscript. Of course, I made the necessary changes.

Thank you very much for this comment.

Being a small population may be easier to offer to the reader more data regarding the index event:

The study involved people after an ischemic stroke who were hospitalized. The patients stayed in the Teaching Department and of the Physical Medicine Department of the MMI, which I wrote about in the Results section. Perhaps, however, I did not present the respondents clearly enough. Therefore, in the section results and subsection of participants, I have completed the necessary information.

Thank you very much for this suggestion.

2)Please provide a table with a generic definition of infarction location (right/left, deep lacunar, cortical, brain stem).

In line with your suggestion, I added a table to the text that supplemented the information about the respondents. The table can be found in the results section in the participant's subsection (Table 2. The basic epidemiological data of the study population and the clinical control group).

Thank you very much for this comment and valuable suggestion.

Thank you very much for your time.

Reviewer 2 Report

In this paper submitted for publication, authors assessed the effect of a TipStim device based training and the body position on the affected hand motor coordination and grip strength in 29 patients who had sustained an ischemic stroke, 5 to 7 weeks before the inclusion in the study. The authors compared the effects of TipStim training to a “placebo effect” training, proposed for 5 days and compared the results obtained during assessments performed with and without body stabilization.

The design of the study is described as a cross-over design whereas a parallel design is also mentioned later. The cross-over design would have resulted in the same number of patients in the 2 groups, whereas here, it seems that a comparison between all the data obtained from the group A (15 patients, A/B) were compared to those of the group B (14 patients, B/A) which suggests more a parallel design.

The placebo intervention is not well described. If the placebo intervention was designed with no parameters set, does that mean that the device was off? If this was the case, can the study be considered as single-blind?

Regarding the analysis performed to test the carry-over effect, the data obtained from the first and second measurements (Pre A and Pre B ?) were summed whereas a comparison between Pre A data and Pre B data should have been compared. Besides this, a washout period of 9 days is mentioned at the beginning whereas a different period of 1 week is mentioned later-on. The statistical analysis section of the manuscript is not well described and detailed, which do not help the understanding of the design and the analyses performed. The results in the different tables are to be highlighted to distinguish what was really done and what is significant.

Although the study topic is interesting and the results may be relevant for stroke rehabilitation, the design of the study, the allocation of the participants to the study groups and the analyses performed are confusing. I suggest that the article be thoroughly revised, and details provided before considering publication.

Author Response

Manuscript ID: applsci-1576091

Type of manuscript: Article

Dear Reviewers,

Reviewer #2:

Thank you very much for the very quick and thorough analysis of our manuscript.

The following comments and answers:

Indeed, it is a design for a combination of parallel and cross-analysis. The parallel (alternating) design does not require that the number of respondents in both groups be exactly the same. The study design was determined by the number of patients who were eligible for the study after ischemic stroke.

In connection with the above, I have made an appropriate correction in the text. I also decided to change the title of the manuscript.

Thank you very much for pointing this out.

Thank you very much for this comment.

The tipstim® device was not turned off, but the parameters for radial and medial sensation were not set. The patient was treated for 60 minutes, but in this case the fingertips were not stimulated. The patients did not know what tipstim® glove therapy was about. Setting the parameters of the stimulation of the fingertips (radial and medial sensation) is done to the patient's feelings that they did not know about. They knew that they would be wearing a tipstim glove for 60 minutes. Only the person conducting the test saw about setting the parameters or not. Therefore, we considered this to be a single-blinded attempt. Therefore, we decided to study in two parallel groups, giving the therapy and the placebo in reverse order, wanting to avoid the possible question of why they feel once their fingertips are not irritated.

Thank you very much for your thorough analysis of our manuscript.

The procedure for estimating the carry-over effect was taken from the article in which the authors point out the need to sum the results A and B in order to estimate such an effect. Below is the article that I included in the reference at position 42:

Wellek, S., & Blettner, M. (2012). On the proper use of the crossover design in clinical trials: part 18 of a series on evaluation of scientific publications. Deutsches Arzteblatt international, 109 (15), 276–281. https://doi.org/10.3238/arztebl.2012.0276.

This resulted in a shift in the numbering of citations in the text and in the reference list. Moreover, we decided to perform such a procedure in our work, because we decided that calculations separately for both measurements for two groups would not allow for the verification of this issue.

Thank you very much for your thorough analysis and any suggestions.

Thank you very much for this comment.

Besides this, a washout period of 9 days is mentioned at the beginning whereas a different period of 1 week is mentioned later-on.

Indeed, in the text of the work, various terms of the washout period appeared. This was due to the fact that the intervention (tipstim or placebo) was administered on working days from Monday to Friday (5 days). Another intervention was given after the washout period, from the end on Friday, after the next week, on Monday, which was not a week but actually 9 days.

The mistake was corrected in the text of the work and marked in blue.

Thank you very much for this comment.

The statistical analysis section of the manuscript is not well described and detailed, which do not help the understanding of the design and the analyses performed. The results in the different tables are to be highlighted to distinguish what was really done and what is significant.

Almost the entire statistical analysis section has been improved in line with your suggestions and comments. Indeed, by reading the text, it was difficult to find the essence.

Looking through this section, I noticed misinterpretations of the results that were actually correctly shown in the tables. Of course, I made an appropriate correction. Also for the tables. All statistically significant results are shown in bold.

Thank you very much for following our work carefully and insightfully.

We hope that the manuscript in its current form is understandable, still interesting and worth considering for publication.

If any ambiguities or errors are still included, please feel free to give some tips so that we can write as correctly as possible.

Thank you very much for your insightful analysis, contribution and time.

Yours faithfully.

Reviewer 3 Report

The paper presents the assessment of the impact of the TipStim devaice application and the study position on motor coordination and grip strength of the affected upper limb in patients after ischemic stroke-a randomized crossover trial.

The study is well conducted and documented, and the data obtained statistical seams to be corelated. The study and the result is quite interesting however the author should consider rephrasing some of the sentences from the paper because there are some long sentences that are not that easy to follow:

-please revise the abstract section, because is hard to follow;

-maybe evaluate the length of the title which is a little bit long;

-please add reference in text for Do Ji-Hye 2016

-overall the grammar should be revised and all typos corrected.

-maybe state future work in the conclusion section

Best regards

Author Response

Manuscript ID: applsci-1576091

Type of manuscript: Article

Dear Reviewers,

Reviewer #3:

Thank you very much for the very quick and thorough analysis of our manuscript.

The following comments and answers:

The study is well conducted and documented, and the data obtained statistical seams to be corelated.

Thank you very much for your appreciation for our manuscript.

The study and the result is quite interesting however the author should consider rephrasing some of the sentences from the paper because there are some long sentences that are not that easy to follow:

-please revise the abstract section, because is hard to follow;

In line with your suggestion, I have changed the abstract a bit. Hope it's easy to follow as it stands.

Thank you very much for your comment.

-maybe evaluate the length of the title which is a little bit long;

In line with your suggestion, I have shortened the title of the manuscript a bit.

Thank you for drawing my attention to the title.

-please add reference in text for Do Ji-Hye 2016

On page 2 of the manuscript there is an annotation concerning the researcher Do Ji-hye, and further in parentheses, according to the order of citation, there is, inter alia, the number [19, ....]. This number is used as a reference in the citation list. Thank you for paying attention to this citation. I made a correction to make the reference consistent with others.

Thank you for your comment.

-overall the grammar should be revised and all typos corrected.

I checked the manuscript for grammar and typos. I hope I have taken into account all the mistakes that exist.

Thank you very much for the careful study of the manuscript.

-maybe state future work in the conclusion section

In line with your suggestion, I have slightly changed the Conclusions section, extending it to include works that may be considered in the future.

Thank you very much for your comment.

Thank you very much for your time.

Reviewer 4 Report

This preliminary study was to examine the effect of using TipStim device and the tested body position and affected upper limb on parameters of motor coordination and the grip strength in patients after a ischemic stroke. Twenty-nine patients after 5-7 weeks with ischemic cerebral stroke were recruited in the test (TipStim group); another group with 29 patients after stroke was used for comparison (placebo group). The TipStim device was then used to achieve coordinated hand movement and to improve grip hand. HandTutor was used to measure motor coordination parameters and an electronic hand dynamometer was used to measure grip strength, with 2 positions of sitting (unstable) and lying with the trunk and affected upper limb stabilized. Results showed that the TipStim group obtained significant effects on the motor coordination and hand grip in both the stable and unstable position of the trunk and upper limb. In addition, more significant differences were found in the Placebo group in the stable position.

I believe that this study is interesting and valuable for the clinical purpose for patients after ischemic stroke. One of the issues I most concern about this paper is its sample size. Because of the relatively small sample size, the effects of the testing variables may be interfered by the individual difference. As we know that the patients with stroke are always varied case-by-case in the stroke condition. The study may have to emphasize its preliminary, even though the study limitation had been noted in subsection 4.2.

Another issue regarding the manuscript is in its English writing. Although the written English may be not bad, there are grammatical and phrasing errors that need to be corrected. Please check the English writing throughout the manuscript. Because of the manuscript is lacking in line numbers (this is very strange as my previous experience in MDPI journals), I cannot indicate the details where places need to be corrected. Taking the Abstract as an example here:

“An electronic hand dynamometer ‘was’ used to measure grip strength.”.

“The TipStim group obtained statistically significant differences in the results of motor coordination (wrist Hz p˂0,001 and fingers Hz 2-5 p˂0,001) and hand grip in both the stable and unstable position of the trunk and upper limb.” The sentence is difficult to be clearly understood and please also check if some information was lost in (wrist Hz p˂0,001 and fingers Hz 2-5 p˂0,001).

“Comparing the influence of the examined item, more statistically significant differences were found in the Placebo group in the stable position (wrist p=0,007, eg. 5 finger p=0,038)”, please clarify than what? I suggest that this should follow the usage of general scientific reports.

Tipstim or Tip Stim?

----------------------------------------------------------------

Other suggestions and comments for the manuscript are as follows. Again, because of the manuscript is lacking in line numbers, I cannot indicate the corrections in detail.

The section of Introduction should be more clearly stated and, in my opinion, it should initially present a more general approach and gradually address the problem (gap) and then present the objective. In the manuscript, the first paragraph is too long to be clearly read. Please separate it to 2-3 paragraph and just highlight one concept for each. On the contrary, the last three paragraphs in the section was suggested to be merged into one paragraph for highlighting the study rationale, objective, and the testing hypothesis appropriately. I also suggest that in the section, results of the Tipstim used in the previous studies should be added. I do not think it is enough in the current content (mainly cited was reference [38] form the Tipstim instruction manual).

Page 1, last sentence, Kelso (1994), please make the citing format consistent (MDPI journal format). Also, Page 12, Brunnstrom (1970).

All figures should be scaling down to their proper size. The participants appeared in Figures 2 and 3 should be at least masked on their eyes.

Subsection 2.2, When reporting “The research was carried out in accordance with the protocol No. 6/KRN/2019”, please provide more clear information.

When I read the contents of the subsection 2.2 for testing intervention, I think that the authors referred to previous papers that proposed the process. Please cited the related references.

Page 12, when saying “the research showed no significant dependencies between the parameters of movement coordination, grip strength, and median and ulnar feeling of the examined people. The TipStim device used only five times does not significantly change the coordination of movement and the grip strength of the hand. In truth, the TipStim instruction for use does not provide information about the categorical purpose of the TipStim device only for therapy, but our study showed that using Tipstim five times is not enough to improve motor coordination.” This may imply the lacking in the experimental design. More technical or theoretical explanation may be helpful for better clarifications to the results.

Author Response

Manuscript ID: applsci-1576091

Type of manuscript: Article

Dear Reviewers,

Reviewer #4:

Thank you very much for the very quick and thorough analysis of our manuscript.

The following comments and answers:

Thank you for your appreciation for our manuscript.

We decided to run cross-over and parallel group studies precisely because we had few stroke patients enrolled in the study. Cross-study is an alternative for a small group of test persons. In this type of study, the patients are in control of themselves, which gives greater precision in the study and it is easier to avoid the influence of confounding variables. Of course, we are aware of the relatively small number of people surveyed and that is why such information appeared in the text of the paper as a limitation of the research.

Thank you very much for this comment.

“An electronic hand dynamometer ‘was’ used to measure grip strength.”.

The manuscript was subject to grammar and linguistic correction.

This sentence has been changed to a sentence:

" We also used an electronic dynamometer to measure the handgrip strength..”

Thank you very much for pointing out the error.

After analyzing the manuscript (results section), this sentence was changed to the sentence:

"The analysis showed smaller differences between the measurements in the A/B group than in the B/A group, both without stabilization and with stabilization (wrist Hz= p˂0,001; fingers 2-5 Hz = p˂0,001; handgrip strength=p˂0.049 and p˂0.003)."

Thank you very much for this comment.

Taking into account your suggestion, this sentence has been changed to the following sentence: "When comparing the influence of the tested position on the results of motor coordination and the handgrip strength, statistically significant differences were found in the placebo group in a stable position (Hz wrist p = 0.007, MaxROM wrist =0.038, HzF5=0.039, MaxROM F4=0.035, HzF3=0.035, MaxROM F3=0.010, HzF2=0.049)."

Thank you very much for your thorough analysis.

Thank you very much for this comment.

Tipstim or Tip Stim?

It should be a tipstim®, which is why corrections have been made in the title of the work and throughout the work.

Thank you very much for paying attention to this.

----------------------------------------------------------------

Other suggestions and comments for the manuscript are as follows. Again, because of the manuscript is lacking in line numbers, I cannot indicate the corrections in detail.

In line with your suggestion, I changed the layout of the introduction section as well as tried to take into account the other suggestions related to the introduction section. All changes are visible in the track changes mode and underlined in blue.

Thank you very much for the thorough analysis of our manuscript.

Page 1, last sentence, Kelso (1994), please make the citing format consistent (MDPI journal format). Also, Page 12, Brunnstrom (1970).

The citation format has been standardized according to the MDPI journal format.

Thank you very much for this comment.

All figures should be scaling down to their proper size. The participants appeared in Figures 2 and 3 should be at least masked on their eyes.

The figures have been reduced to the required size and the eyes have been masked.

Thank you very much for this comment.

Subsection 2.2, When reporting “The research was carried out in accordance with the protocol No. 6/KRN/2019”, please provide more clear information.

Protocol no 6/ KRN/2019 has been registered in Clinical Trials Registration and such completion is included in the text. Thank you. It was corrected.

When I read the contents of the subsection 2.2 for testing intervention, I think that the authors referred to previous papers that proposed the process. Please cited the related references.

In line with your suggestion, a new reference has been introduced:

Wellek S, Blettner M. On the proper use of the crossover design in clinical trials: part 18 of a series on evaluation of scientific publications. Deutsches Arzteblatt international, (2012), 109 (15), 276–281. doi.org/10.3238/arztebl.2012.0276.

Thank you very much for this comment.

A careful analysis of the data in the results section resulted in the introduction of corrections throughout the work as well as the re-editing of the discussion section. I hope that the current form of concluding the discussion is understandable and that it explains the research better.

Thank you for your very thorough analysis of our manuscript.

Thank you very much for your time.

Round 2

Reviewer 1 Report

none

Author Response

Manuscript ID: applsci-1576091

Type of manuscript: Article

Full title: Assessment of the impact of the tipstim® device application and the study position on motor coordination and grip strength of the affected upper limb post-ischemic stroke - a randomized parallel crossover trial.

Dear Reviewers,

Thank you very much for analyzing our manuscript.

Taking into account all the suggestions, all the mistakes were corrected. To avoid misunderstandings, changes to the text this time are marked in green, and the manuscript has been sent in the track changes mode.

Reviewer #1:

Thank you very much for approving the revised text of our manuscript.

Thank you very much for your time.

Reviewer 2 Report

The manuscript has been significantly improved and can be accepted for publication. I do have a few additional minor comments:

Appropriate references need to be added regarding the design used in the study.
If the parameters were not set during the placebo therapy, I assume the patients did not feel the stimulation as compared to the actual tipstim intervention, thus considering the study as single-blinded need to be justified.
The different times of assessment needs to be clarified: "...was performed on the first day of therapy, after the tistim®/placebo intervention, and after 5 days of therapy/placebo."

Is there any difference between the results after the first session and after 5 sessions ?

The statistical analysis section can be improved by describing the specific analysis ran for each study question.

I would like to thank the authors for their detailed response to my comments and extensive revision of their manuscript.

Author Response

Manuscript ID: applsci-1576091

Type of manuscript: Article

Dear Reviewers,

Thank you very much for analyzing our manuscript.

Reviewer #2:

Thank you very much for the quick and very thorough analysis of our manuscript.

The following comments and answers:

The manuscript has been significantly improved and can be accepted for publication.

Thank you very much for your appreciation for our manuscript.

I do have a few additional minor comments:

Appropriate references need to be added regarding the design used in the study.

If the parameters were not set during the placebo therapy, I assume the patients did not feel the stimulation as compared to the actual tipstim intervention, thus considering the study as single-blinded need to be justified.

In the section on design study, I added a reference, the number of which is listed under number 42.

Wellek, S., & Blettner, M. (2012). On the proper use of the crossover design in clinical trials: part 18 of a series on evaluation of scientific publications. Deutsches Arzteblatt international, 109 (15), 276–281. https://doi.org/10.3238/arztebl.2012.0276.

Besides, I described what a single blindness was in our study: "The patients did not know what the treatment with tipstim® gloves was about. All they knew was that a tipstim® glove would be put on their affected hand and that they would stay in it for 60 minutes. Only the examiner knew which of the patients to set the parameters or not.

Section 2.1. Trial design has been completed and the sentence is marked in green.

Thank you very much for your thorough evaluation of our work.

The different times of assessment needs to be clarified: "...was performed on the first day of therapy, after the tistim®/placebo intervention, and after 5 days of therapy/placebo."

On the first day of therapy means before the first session ? after the tipstim/placebo intervention: does this mean after the first day of intervention ? Please clarify and correct the typo (bolded word). Is there any difference between the results after the first session and after 5 sessions ?

There is indeed a mistake as to the timing of the intervention studies being carried out. The sentence should read:

"The assessment of motor coordination and the measurement of handgrip strength was performed on the fifth day of therapy, after the tistim® / placebo intervention, and after the next 5 days of therapy / placebo", and that is the present form.

I corrected the text by marking it in green.

I wasn't sure which bold words we were talking about. I looked through the text and eliminated any bold words apart from the relevant results shown in the tables in the results section.

Thank you very much for the great accuracy and insight in the evaluation of this work.

The statistical analysis section can be improved by describing the specific analysis ran for each study question.

If I understand this comment correctly, it is a suggestion to write research questions. I did this, adding research questions in section 3.2. Outcomes and estimation. You can read the following research questions:

Does the study design minimize carry-over effects?
Are there differences in the results between the first and second measurements in each of the groups A/B and B/A?
Will there be a significant difference in the measured parameters in the non-stabilized and stable position depending on the study group (timstim® vs. placebo)?
Is there a relationship between the tipstim® parameters (median and ulnar sensation) and the parameters of motor coordination and handgrip strength?

If I did not understand the suggestion well, please comment.

Thank you for your careful study of the manuscript.

I would like to thank the authors for their detailed response to my comments and extensive revision of their manuscript.

Dear reviewer, we hope to have answered all your suggestions.

Once again, thank you very much for your appreciation for our manuscript.

Best regards

Authors

Reviewer 4 Report

Thanks to the authors for many words that have been devoted to respond my previous review comments. Even though the relatively small sample size is an issue (it cannot be change in this stage), I believe that the study is still contributive to the field. I have thus no further suggestions for the revised manuscript, and congratulations to the authors for a very well-crafted revision of the manuscript.

However, if possible, I suggest that the last paragraph of original 4.3. Conclusions could be moved to and merged into the end of subsection of study limitation (4.2). The Conclusions should be also retitled by 5. Conclusion, not 4.3.

Author Response

Manuscript ID: applsci-1576091

Type of manuscript: Article

Dear Reviewers,

Thank you very much for analyzing our manuscript.

Reviewer #4:

Thank you very much for the quick and very thorough analysis of our manuscript.

The following comments and answers:

Thank you very much for your appreciation for our manuscript.

As suggested, I changed the numbering of the applications section to:

Conclusions

Conclusions, if I understand correctly, are under limitations.

Dear reviewer, we hope to have answered all your suggestions.

Once again, thank you very much for your appreciation for our manuscript.

Best regards

Authors

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Assessment of the Impact of the Tipstim^® Device Application and the Study Position on Motor Coordination and Grip Strength of the Affected Upper Limb Post-Ischemic Stroke—A Randomized Parallel Crossover Trial

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Assessment of the Impact of the Tipstim® Device Application and the Study Position on Motor Coordination and Grip Strength of the Affected Upper Limb Post-Ischemic Stroke—A Randomized Parallel Crossover Trial

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MDPI Initiatives

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Assessment of the Impact of the Tipstim^® Device Application and the Study Position on Motor Coordination and Grip Strength of the Affected Upper Limb Post-Ischemic Stroke—A Randomized Parallel Crossover Trial