Development and Trial of a Prototype Device for Sensorimotor Therapy in Patients with Distal Radius Fractures
Round 1
Reviewer 1 Report
This study examined the feasibility of a clinical use of a prototype device (developed code: Ghost) to facilitate the recovery of the range of motion (RoM) in patients with a radius fracture (DRF) during the acute phase.
The authors tested the device into two groups: the patients into the Ghost and the control group. More improvement in RoM by Ghost during the acute phase of DRF was observed in younger, and normal and low weight patients.
These authors stated that further study is needed to verify this prototype, and to assess the extent of RoM recovery.
The study is interesting.
There are some weaknesses that need to be fixed.
1) The introduction must be more focused on the background and related works.
2) The part of the introduction dedicated to the description of the tool must be recalled briefly here. Instrument images need to be moved elsewhere (but see later)
3) The description of the tool is fragmented ​​and poor. The images do not help the understanding of the work done.
4) Insert a paragraph entirely dedicated to the instrument. Help yourself with flow charts and block diagrams. Enter all the details and information useful to the reader from risk to certification.
5) Insert figures with important and useful content. Some seem partly repeated (with zoom in and zoom out) and with useless details (HDMI connection ... etc.)
6) Have you thought about acceptance studies or at least collections of comments and suggestions?
7) Have you worked with any physiotherapists?
8) Conclusions “Conclusions
studies should control for the characteristics of patients, enroll the required number of
participants, and verify whether the intervention effect can be generalized. Additionally,
to generalize the use of Ghost, it is necessary to consider the method of operating
device and patient fatigue. " It is ok to add the future work, however explain it better. You have inserted too many information into two sentences
I repeat.
In my opinion the work has merits. My suggestions do not detract from the value of the study which in my opinion is very innovative and interesting.
Author Response
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Author Response File: 
Author Response.docx
Reviewer 2 Report
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Comments for author File: 
Comments.pdf
Author Response
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Author Response File: Author Response.docx
Round 2
Reviewer 1 Report
The quality of the manuscript improved a lot. My opinion is that it can be accepted.
Reviewer 2 Report
The authors have incorporated all the comments from the reviewer.
This manuscript is a resubmission of an earlier submission. The following is a list of the peer review reports and author responses from that submission.
Round 1
Reviewer 1 Report
This manuscript presents an interesting physical therapy platform, named Ghost, to improve the outcome of patients after distal radius fractures. By utilizing vibration and VR stimuli, it is claimed that the Ghost system shows a greater improvement in forearm supination than that of the patients in the control group, which is important for the recovery of patients. I have several questions regarding the characterization and analysis of this platform that should be addressed before the paper can be considered for publication.
My specific comments are below:
- For statistical analysis in Eq 1 and 2, the abbreviations, like SEM and ICC, should be briefly defined before use.
- The minimal detectable change (MDC) is misused and some of they are even written as MCD.
- In figure 4, the data points are not clear. And there could be appropriately defined error bars in both groups.
- The time courses in Fig. 5 could be consistent with Fig. 4 for a clearer comparison. The higher probability of improvement over MDC in Ghost group in Fig. 5 only has mathematical meaning, because the obvious data deviation in control group (Fig. 4) leads to a larger MDC value and lower probability of improvement in Fig. 5. It has nothing to do with better outcomes in the Ghost group.
Author Response
Reviewer #1
The overall feedback of was that “This manuscript presents an interesting physical therapy platform, named Ghost, to improve the outcome of patients after distal radius fractures. By utilizing vibration and VR stimuli, it is claimed that the Ghost system shows a greater improvement in forearm supination than that of the patients in the control group, which is important for the recovery of patients. I have several questions regarding the characterization and analysis of this platform that should be addressed before the paper can be considered for publication.”
Response to Reviewer #1
The comment encouraged us greatly.
Comment 1. For statistical analysis in Eq 1 and 2, the abbreviations, like SEM and ICC, should be briefly defined before use.
Response to Comment 1
Reviewer 1’s comment accurately pointed to the shortcomings of our manuscript and helped us to improve our manuscript. The sample size for this study was too small to analyze; therefore, we decided not to report inferential statistics in the revised manuscript. Instead, we presented simple results. The standard error of measurement and intraclass correlation coefficient (ICC) were deleted.
Comment 2. The minimal detectable change (MDC) is misused and some of they are even written as MCD.
Response to Comment 2. We have deleted the incorrect notation of MDC.
Comment 3. In figure 4, the data points are not clear. And there could be appropriately defined error bars in both groups.
Response to Comment 3. We have changed Figure 4 according to the comment. The actual RoM angles of the patients are represented with box plots.
Comment 4. The time courses in Fig. 5 could be consistent with Fig. 4 for a clearer comparison. The higher probability of improvement over MDC in Ghost group in Fig. 5 only has mathematical meaning, because the obvious data deviation in control group (Fig. 4) leads to a larger MDC value and lower probability of improvement in Fig. 5. It has nothing to do with better outcomes in the Ghost group.
Response to Comment 4. Figure 4 has been redrawn and Figure 5 was removed according to the comment. We have deleted the text describing better outcomes of the Ghost intervention and its ability to statistically outperform MDC recovery compared to vibration-only in the Discussion section. We improved the Discussion section (page 11, lines 279-282) as follows:
“During DRF treatment in the acute phase, the wrist joint must be immobilized. Ghost is available for use during this period. During this study, both interventions resulted in similar improvements in the RoM over time for DRF patients. The intervention with Ghost in acute phase was expected to have the same therapeutic results as the conventional method.”
Reviewer 2 Report
Page 1 line 40: Change to DRF
Page 1 line 41: The analgesic mechanism associated with vibration needs to be clarified. A reference appropriate for musculoskeletal conditions should be provided.
Page 1 lone 42: If visual stimuli provided pain relief as suggested, the chronic pain epidemic would not exist. The potential mechanisms associated with visual stimuli and analgesia should be briefly covered.
Page 1 line 44 and page 2 line 45: What sort of virtual reality are you referring to. You need more information.
Page 3 line 90 to 91: I would remove this sentence as it is not appropriate for the methods section.
Page 3 line 94: It is unclear what the “minimization method” for bone alignment is.
Lines 120-125: I would suggest the use of wrist “flexion” or “extension” when talking about movement.
Lines 173-183: What tool was utilised to ROM measurements? Was it an analogue goniometer or a digital goniometer? What is the reliability of these measurements? What is the minimal clinically important difference for these measures? Please consider having a look at the literature to answer these questions and report the information in text. You can start by having a look at (Reissner et al., 2019).
Line 218: I realise that the authors may have spent a significant amount of time completing inferential statistics. However, considering the small sample size (15 participants in total) and the pilot nature of the study, I suggest not to run inferential statistics and simply report results as mean/medians/percentages and SD/95% CI, or interquartile range. Please refer to (Abbott, 2014), (Arain, Campbell, Cooper, & Lancaster, 2010), and (Eldridge et al., 2016).
Lines 237-239: The difference between the two groups is very small for all the ROM measured. Even assuming that you utilised a 3D motion capture system, the difference does not reach the minimal detectable change for those measurements (Reissner et al., 2019).
Figure 4 and Table 3: The supination values in the figure do not match the values reported in the table.
Line 247: I suggest rewording the sentence in a way that does not suggest a difference between groups as there is not one.
Lines 260-261: The number of supination reported here do not match the ones reported in table 3.
Lines 255-264: Rather than MCD based on 95% confidence intervals I would base the categorisation into 0 or 1 based on the minimal detectable change for those measurements (Reissner et al., 2019). Additionally, I would present this analysis as an exploratory exercise if you would like to retain it into your manuscript. Personally, I would remove it as you performed it on supination only, which by the way showed no statistically relevant differences between groups on post hoc testing. Additionally, I would not report inferential statistics as the sample size is small and pilot studies should not report inferential statistics.
Lines 286-289: I would rephrase this sentence as it can lead readers to think that there were significant changes. The difference in supination at 14 days was the only difference across several time points and across multiple measurements (wrist extension/flexion, radial/ulnar deviation etc.). The likelihood of this result being due to a type I error is high. In addition, as mentioned above, I would complete the logistic regression utilising previously recognised minimal detectable change (Reissner et al., 2019).
Discussion: The discussion will need to be reviewed once the changes mentioned above are completed.
Abbott, J. H. (2014). The Distinction Between Randomized Clinical Trials (RCTs) and Preliminary Feasibility and Pilot Studies: What They Are and Are Not. Journal of Orthopaedic and Sports Physical Therapy, 44(8), 555-558. doi:10.2519/jospt.2014.0110
Arain, M., Campbell, M. J., Cooper, C. L., & Lancaster, G. A. (2010). What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Medical Research Methodology, 10, 67. doi:10.1186/1471-2288-10-67
Eldridge, S. M., Chan, C. L., Campbell, M. J., Bond, C. M., Hopewell, S., Thabane, L., . . . on behalf of the, P. c. g. (2016). CONSORT 2010 statement: Extension to randomised pilot and feasibility trials. Pilot and Feasibility Studies, 2(1), 64. doi:10.1186/s40814-016-0105-8
Reissner, L., Fischer, G., List, R., Taylor, W. R., Giovanoli, P., & Calcagni, M. (2019). Minimal detectable difference of the finger and wrist range of motion: comparison of goniometry and 3D motion analysis. Journal of Orthopaedic Surgery and Research, 14(1), 173-173. doi:10.1186/s13018-019-1177-y
Author Response
Reviewer #2
Comment 1. Page 1 line 40: Change to DRF
Response to Comment 1. We appreciate the reviewer to let us realize the mistake, changed to “DRF.”
Comment 2. Page 1 line 41: The analgesic mechanism associated with vibration needs to be clarified. A reference appropriate for musculoskeletal conditions should be provided.
Response to Comment 2. We improved the introduction section (pages 1-2, lines 43-45) based on the comment as follows:
“Vibration seems to provoke the interaction of the neurophysiologic sensors and the adjustment of afferent signals that are possibly acting via the sensorimotor system [8,9].”
Comment 3. Page 1 lone 42: If visual stimuli provided pain relief as suggested, the chronic pain epidemic would not exist. The potential mechanisms associated with visual stimuli and analgesia should be briefly covered.
Response to Comment 3. We improved the part by adding information about potential mechanisms associated with visual stimuli and analgesia (page 2, lines 46-51) as follows:
“Motor imagery and action observation could have important roles in the field of rehabilitation for patients with musculoskeletal pain [11]. The visual analgesia might reflect interplay between networks involved in viewing the body and networks responsive to nociceptive inputs [12].”
Comment 4. Page 1 line 44 and page 2 line 45: What sort of virtual reality are you referring to. You need more information.
Response to Comment 4. We improved the part by adding information to describe virtual reality using 3D TV with references (page 2, lines 51-53) as follows:
“One study found that a virtual reality (VR) system using a monitor provides a three-dimentional (3D) picture image has the potential to improve RoM and alleviate pain among patients with knee osteoarthritis [13,14].”
Comment 5. Page 3 line 90 to 91: I would remove this sentence as it is not appropriate for the methods section.
Response to Comment 5. We have removed this sentence according to the comment.
Comment 6. Page 3 line 94: It is unclear what the “minimization method” for bone alignment is.
Response to Comment 6. We added the explanation of the "minimization method" for bone alignment (Page 3, lines 100-104) as follows:
“Patients were assigned to the tendon vibration stimulus group (control group) or the Ghost group (combined tendon vibration stimulus and visual stimulus group) using the minimization method, AO method, and radiographic parameters to determine the bone alignment and fracture classification. The severity of fractures was similar in both groups.”
Comment 7. Lines 120-125: I would suggest the use of wrist “flexion” or “extension” when talking about movement.
Response to Comment 7. We have corrected “dorsiflexed” to “extension” (page 3, lines 131-132) according to your comment.
Comment 8. Lines 173-183: What tool was utilized to ROM measurements? Was it an analogue goniometer or a digital goniometer? What is the reliability of these measurements? What is the minimal clinically important difference for these measures? Please consider having a look at the literature to answer these questions and report the information in text. You can start by having a look at (Reissner et al., 2019).
Response to Comment 8. We thank for this useful information. We used an analog goniometer. We added text with a reference to Dr. Reissner’s research [19] (page 5, lines 185-188).
Comment 9. Line 218: I realize that the authors may have spent a significant amount of time completing inferential statistics. However, considering the small sample size (15 participants in total) and the pilot nature of the study, I suggest not to run inferential statistics and simply report results as mean/medians/percentages and SD/95% CI, or interquartile range. Please refer to (Abbott, 2014), (Arain, Campbell, Cooper, & Lancaster, 2010), and (Eldridge et al., 2016).
Response to Comment 9. This study was a pilot study, thus, we did not perform inference statistics. We improved Tables and Figures according to your comment. Tables 3-6 and Figure 5 was deleted and Figures 4-7 were added instead.
Comment 10. Lines 237-239: The difference between the two groups is very small for all the ROM measured. Even assuming that you utilized a 3D motion capture system, the difference does not reach the minimal detectable change for those measurements (Reissner et al., 2019).
Response to Comment 10. During this study, we did not perform inferential statistics between groups. A comparison of Ghost and other interventions is the subject of our next study.
Comment 11. Figure 4 and Table 3: The supination values in the figure do not match the values reported in the table.
Response to Comment 11. We thank Reviewer2 for reviewing our data very carefully. We corrected the data of Figure 4.
Comment 12. Line 247: I suggest rewording the sentence in a way that does not suggest a difference between groups as there is not one.
Response to Comment 12. We improved the title of Figure 2 and the legend (page 4, lines 154-155) according to your comment as follows:
“Sequences of stimuli. The upper panel shows the Ghost group. The lower panel shows the control group. Patients in both groups were placed in the resting position with their hands folded.”
Comment 13. Lines 260-261: The number of supination reported here do not match the ones reported in table 3.
Response to Comment 13. The supination value of the submitted manuscript was different from the description in Table 3. We deleted Table 3, and Figures 4 and 5 have been added.
Comment 14. Lines 255-264: Rather than MCD based on 95% confidence intervals I would base the categorisation into 0 or 1 based on the minimal detectable change for those measurements (Reissner et al., 2019). Additionally, I would present this analysis as an exploratory exercise if you would like to retain it into your manuscript. Personally, I would remove it as you performed it on supination only, which by the way showed no statistically relevant differences between groups on post hoc testing. Additionally, I would not report inferential statistics as the sample size is small and pilot studies should not report inferential statistics.
Response to Comment 14. We performed a logistic regression analysis and calculated the MDC based on the 95% confidence interval of RoM data, which was converted to 1 or more and 0 or less. In accordance with the reviewer’s opinion, we decided not to report inferential statistics in the revised manuscript.
Comment 15. Lines 286-289: I would rephrase this sentence as it can lead readers to think that there were significant changes. The difference in supination at 14 days was the only difference across several time points and across multiple measurements (wrist extension/flexion, radial/ulnar deviation etc.). The likelihood of this result being due to a type I error is high. In addition, as mentioned above, I would complete the logistic regression utilizing previously recognized minimal detectable change (Reissner et al., 2019).
Response to Comment 15.　We improved the statistical methods (Page 6, lines 231-233) as follows:
“Statistical analyses were not conducted because this pilot study was conducted to investigate the feasibility of Ghost for clinical use. The acquired data are shown as basic statistical values.”
Comment 16. Discussion: The discussion will need to be reviewed once the changes mentioned above are completed.
Response to Comment 16. In the Discussion section, we have removed all the statements about Ghost being shown to be effective.
Reviewer 3 Report
Thank you very much for the invitation to review the manuscript entitled “Development and trial of a prototype device for sensorimotor therapy in patients with distal radius fractures ” which aims to
I have revised the manuscript and provide some comments and suggestions which I hope the Authors will take into account. The following general and specific comments on the manuscript are offered to help strengthen the manuscript :
The abstract should be improved: the justification and objective of the study should be clearly provided.
In the introduction section the objective of the study is not clearly stated.
Patients were not randomly allocated to the group which is an important limitation of the study and sample size is too small. Thus the results cannot be generalized.
The design of the study is not clearly stated.
Was any guidelines used to follow the study? CONSORT; STROBE…?
Were the evaluators blinded to the group assignments?
In Table 2. Characteristics of patients with distal radius fracture units are not reported for age (years) BMI (kg/m2)…
Author Response
Reviewer #3
Thank you very much for the invitation to review the manuscript entitled “Development and trial of a prototype device for sensorimotor therapy in patients with distal radius fractures” which aims to
I have revised the manuscript and provide some comments and suggestions which I hope the Authors will take into account. The following general and specific comments on the manuscript are offered to help strengthen the manuscript:
Comment 1. The abstract should be improved: the justification and objective of the study should be clearly provided.
Response to Comment 1. We thank Reviewer 3 for these comments that have helped us to improve our manuscript. We improved the Abstract as follows:
“A distal radius fracture (DRF) requires immobilization after surgery and restriction of the range of motion (RoM) during the acute phase. We developed a prototype device (development code: Ghost) to facilitate the recovery of the RoM during a period of joint immobility in the acute phase of the DRF. Ghost consists of a combination of vibration stimuli (70-80 Hz for 30 s on the extensor carpi ulnaris tendon on the non-injured side) and visual stimuli (from a head-mounted display). To investigate the feasibility of Ghost, we divided the patients into two groups: the Ghost group (n=10) and the control group (n=5; tendon vibration only). The experimental interventions were administered between the day after surgery and day 7 postoperatively. Traditional hand therapy was provided to both groups. The primary outcome was the RoM on the injured side, which was measured on days 7, 14, 28, 42, 56, 70, and 84. The acquired data are shown as basic statistical values. Both interventions improved the RoM over time. The results of this study may be useful for introducing Ghost in future DRF treatments and verifying its effectiveness.”
Comment 2. In the introduction section the objective of the study is not clearly stated.
Response to Comment 2. We improved the introduction section (page 2, lines 59-66) according to your comment as follows:
“We examined its feasibility for clinical use during a preliminary study involving a small sample. We also identified issues that can be addressed in future studies.
This study addressed the following research questions:
(1) Is the new device applicable during a period of time when the wrist joint is restricted?
(2) Would recovery be affected by the use of Ghost during the period of time when the wrist joint is restricted?”
Comment 3. Patients were not randomly allocated to the group which is an important limitation of the study and sample size is too small. Thus the results cannot be generalized.
Response to Comment 3. The sample size for this study was too small to generalize results. Therefore, the inferential analysis was canceled and only the basic statistical values are shown.
Comment 4. The design of the study is not clearly stated.
Response to Comment 4. We added the following sentence: “This study had an intervention study design because it was intended to examine the feasibility of the device.”　(page 2, lines 71-72)
Comment 5. Was any guidelines used to follow the study? CONSORT; STROBE…?
Response to Comment 5. It was not possible to support all of CONSORT because this research was aimed at investigating the feasibility of the device. However, we have described headings of revised manuscript according to CONSORT.
Comment 6. Were the evaluators blinded to the group assignments?
Response to Comment 6. We did not blind to the group assignments to the evaluators. Evaluators, patients, and analyzers should be blinded to ensure the reliability of the study data. We added text in the Discussion section (pages 11-12, lines 330-333) as follows:
“There were some limitations to this study. Because this study was conducted as a preliminary experiment to examine the feasibility of Ghost, the patients were not randomly selected. Patient randomization and blinding interventions should be performed to demonstrate the dominance of Ghost.”
Comment 7. In Table 2. Characteristics of patients with distal radius fracture units are not reported for age (years) BMI (kg/m2)…
Response to Comment 7. We added the units of reported values in Table 2 according to the comment.
Reviewer 4 Report
Thank you for the opportunity to review this article.
The main issue of distal radius fracture (DRF) is the restriction of range of motion (ROM). The lack of ROM and pain strongly affect the ability of patients to regain complete independence while performing daily activities. The topic seems to be necessary. The authors implemented interesting new technologies to improve the ROM in these patients. The work was written interestingly.
The research's weak part is unequal and relatively small groups( especially the control group consisting of 5 people). It is difficult to use advanced and objective statistical methods to compare such small groups. The authors are aware of the limitations and describe them. In my opinion, this pilot study is suitable for publication in this journal in its current version.
Author Response
Reviewer #4
Thank you for the opportunity to review this article.
The main issue of distal radius fracture (DRF) is the restriction of range of motion (ROM). The lack of ROM and pain strongly affect the ability of patients to regain complete independence while performing daily activities. The topic seems to be necessary. The authors implemented interesting new technologies to improve the ROM in these patients. The work was written interestingly.
Comment 1. The research's weak part is unequal and relatively small groups　(especially the control group consisting of 5 people). It is difficult to use advanced and objective statistical methods to compare such small groups. The authors are aware of the limitations and describe them. In my opinion, this pilot study is suitable for publication in this journal in its current version.
Response to Comment 7. We appreciate the understanding and interpretation of Reviewer 4. We hope that this pilot study for the practical application of Ghost can be scientifically shared as a reference for future research. Because of the meaningful comments from other Reviewers, we decided to remove the inferential analysis and present the actual data. We have changed and improved the manuscript according to the comment from four reviewers.
Round 2
Reviewer 1 Report
No further comments
Reviewer 3 Report
Thank you very much for the invitation to re - review the manuscript entitled “Development and trial of a prototype device for sensorimotor therapy in patients with distal radius fractures ” which aims to develop a prototype device (development 9 code: Ghost) to facilitate the recovery of the RoM during a period of joint immobility in the acute 10 phase of the distal radius fractures.
I have revised the new version of the manuscript, in my opinion the work has improved with the changes, however important limitations continue to be present in the work: Patients were not randomly selected; only 15 patients were included in the study, thus the results cannot be generalized.
