Journal of Rehabilitation Medicine 51-5 | Page 79

J Rehabil Med 2019; 51: 395–396 LETTER TO THE EDITOR COMMENTS TO: “CONTRALATERALLY CONTROLLED FUNCTIONAL ELECTRICAL STIMULATION IMPROVES WRIST DORSIFLEXION AND UPPER LIMB FUNCTION IN PATIENTS WITH EARLY-PHASE STROKE: A RANDOMIZED CONTROLLED TRIAL” The recently published article by Zheng et al. (1) is well documented with interesting findings. It concludes that in patients with early-phase stroke, contralaterally controlled functional electrical stimulation (CCFES) is superior to neuromuscular electrical stimulation (NMES) in both shortening the course of regaining wrist dorsiflexion (WD) and recovery of upper extre- mity function. However, some points require further clarification from the authors. First, the study design is described as a randomized controlled trial; however, there is no control group in the study. Perhaps it would be more accurate to describe the study as a 2-group pre-test post-test ex- perimental design (2). Secondly, the early-phase stroke patients’ type is unclear from the inclusion criteria. The authors did not report sensory assessment of the included patients, and thus there is a risk of burn with the reported dosage intensity of NMES (40 mA) in patients with impaired sensations (3). Thirdly, in the section on outcomes measures (p. 105), the authors performed Manual Muscle Testing (MMT) to measure the strength of the extensor carpi. They recruited patients with Brunnstrom recovery stage 3 or less, but, in these stages, patterns of mo- vements occur in association with spasticity. It is advisable to perform group MMT with an appropriate measurement tool, such as a hand-held dynamometer, rather than performing MMT for a specific muscle (4). Fourthly, the authors did not specify the parame- ters (frequency, mode) of CCFES. The parameters of NMES (pp. 104–105) in the study protocol section are also not mentioned clearly. Fifthly, in the statistical analysis it is not clear why the authors used Student’s t-test for analysis of demo- graphic data, as it does not fulfil the assumptions for application of this test. Mann–Whitney U test should be used to determine the inter-group differences for active range of motion (ROM) for WD, strength of extensor carpi, and Jebsen Hand Function Test (JHFT), rather than the Wilcoxon signed-rank test. The authors mention a sample size for the study of 40 participants; however, in the results section under demographic data they have assigned 50 total participants into 2 groups. Thus, the actual sample size requires clarification. Lastly, in Table III, the authors have used means and standard deviations to express the central tendency for both data with a normal distribution and for data without a normal distribution. This is inappropriate; they should have used median and interquartile range to express the central tendency for the non-normally distributed data (5). The work conducted by the authors in this study is, however, commendable for enlightening profes- sionals regarding the authors’ innovative ideas and their application. Accepted Mar 12, 2019; Epub ahead of print Mar 22, 2019 Satkarjit Kaur Jhandi 1 , Manu Goyal 2 and Anjali Tiwari 1 From the 1 Department of Neurological Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar, (Deemed to be University) Mullana-Ambala, Haryana, India and 2 Department of Musculoskeletal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Haryana, India. E-mail: [email protected] RESPONSE TO LETTER TO THE EDITOR FROM ZHENG ET AL. We appreciate the interest from readers and the com- ments by Satkarjit Kaur Jhandi and colleagues. Our response to these comments is as follows. Regarding the study design, there is debate about the definition of “randomized controlled trials (RCT)” and no consensus has yet been reached. In the current study, we considered the group receiving conventio- nal neuromuscular electrical stimulation (NMES) the control group and the group receiving contralaterally controlled functional electrical stimulation (CCFES) the intervention group. We agree that we could also have described the study as having a 2-group pre-test post-test experimental design. The term RCT is, however, usually better understood by the readership and seems justified when participants are randomly assigned to a conven- tional therapy (control) compared with a new therapy. The maximum pulse duration, defined as that which produced maximum wrist dorsiflexion (WD) without pain, while the participant remained relaxed, was de- termined for each electrode. To the best of our know- ledge, several studies have applied the same dosage intensity (40 mA NMES) and no adverse event has been reported. Our colleague Shen et al. applied the same device with a dosage of 0–100 mA and found that This is an open access article under the CC BY-NC license. www.medicaljournals.se/jrm Journal Compilation © 2019 Foundation of Rehabilitation Information. ISSN 1650-1977 doi: 10.2340/16501977-2549