CRITICALLY APPRAISED PAPER (CAP) Cui, B. J., Wang, D. Q., Qiu, J. Q., Huang, L. G., Zeng, F. S., Zhang, Q.,... Sun, Q. S. (2015). Effects of a 12-hour neuromuscular electrical stimulation treatment program on the recovery of upper extremity function in sub-acute stroke patients: A randomized controlled pilot trial. Journal of Physical Therapy Science, 27(7), 2327 2331. http://dx.doi.org/10.1589/jpts.27.2327 CLINICAL BOTTOM LINE: Stroke rehabilitation is an area in which occupational therapists currently work and in which they have the potential to advance the field with evidence-based practice. Therapists working with patients who suffer impaired motor skills after a stroke can use research to apply intervention for rehabilitation. With older adults who have suffered a stroke and have motor impairments as a result, practitioners can determine whether neuromuscular electrical stimulation (NMES) in conjunction with therapy is a beneficial plan. In this article, the researchers used a randomized controlled study to investigate the effects of a 12-hr NMES program in the evening on upper extremity function in subacute stroke patients. One hundred thirty-two patients who had hemiplegia as a result of stroke were recruited from the Second Hospital of Shandong University, and, of those, 45 patients fitted the inclusion criteria, were enrolled in the study, and were randomized into one of three groups. Fifteen participants were randomized into the 12-hr NMES group, 15 participants were randomized into the standard NMES group, and 15 participants were randomized into the control group. Randomization was provided by a computer-generated blocked randomization sequence. The interventions were conducted for 4 weeks. All NMES treatment was given in combination with standard inpatient rehabilitation, including physical therapy, occupational therapy, and speech therapy. At baseline, Week 4, and Week 8, the outcome measures used to detect the effects of therapy and NMES included the Fugl Meyer Assessment, the Action Research Arm Test (ARAT), and the Modified Ashworth Scale. The major limitations of the study include the small sample size (which was partly because this study was an initial assessment of the effects of prolonged NMES treatment), the mixture of stroke types (ischemic and hemorrhagic), and the differences in time since stroke. Although the study has its limitations, it reveals that a 12-hr NMES program can facilitate recovery of motor function after stroke. This was true especially of motor function in the distal upper extremity, because the difference on the ARAT between the two NMES groups was significant. It seems that a 12-hr NMES activated brain plasticity through electrical enhancement of the afferent input. Further investigation of NMES treatment is needed to find the type of stimulation that is most effective, the optimum dose, and the optimum application 1
time after stroke. RESEARCH OBJECTIVE(S) List study objectives. To evaluate the effects of long-duration, low intensity NMES on upper extremity function in stroke patients DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. From July 2012 to May 2014, 132 patients with hemiplegia as a result of a cerebrovascular accident were recruited from the Second Hospital of Shandong University. Inclusion Criteria Age: 18-80 years Time from stroke onset: greater than or equal to 4 weeks First stroke and unilateral movement Medically and neurologically stable condition No visual or auditory defects Exclusion Criteria Recurrent or progressive stroke Preexisting arm impairment, such as rheumatoid arthritis Cardiac pacemaker or other implanted stimulator History of seizures within 2 years History of fatal cardiac arrhythmias Refusal to sign the consent form SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 45 #/ (%) Male 45/(100%) #/ (%) Female 0/(0%) Ethnicity NR Disease/disability diagnosis Hemiparesis after hemorrhagic or ischemic stroke INTERVENTION(S) AND CONTROL GROUPS 2
Add groups if necessary Group 1: 12-hr NMES group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? 12-hr NMES with standard inpatient rehabilitation 15 Group 2: 30-min NMES group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? Inpatient rehabilitation hospital A portable surface neuromuscular stimulator (the article does not report who administered the device). Standard rehabilitation care was provided by occupational therapists, physical therapists, and speech therapists. 6 days a week for 4 weeks 12 consecutive hours of neuromuscular electrical stimulation 30-min NMES with standard inpatient rehabilitation 15 Inpatient rehabilitation hospital A portable surface neuromuscular stimulator (the article does not report who administered the device). Standard rehabilitation care was provided by occupational therapists, physical therapists, and speech therapists. 6 days a week for 4 weeks 30 consecutive minutes of neuromuscular electrical stimulation Group 3: Control group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? Standard inpatient rehabilitation 15 Inpatient rehabilitation hospital Occupational therapists, physical therapists, speech therapists 6 days a week for 4 weeks NR 3
Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: Co-intervention: YES All participants received standard occupational therapy, physical therapy, and speech therapy in the inpatient rehabilitation setting, regardless of NMES treatment group or control group. Timing: Participants in the first intervention group received 12 hr of NMES per day. Participants in the second intervention group received 30 min of NMES per day. Differences in time were interventions, not biases. Site: All treatment provided at the same site Use of different therapists to provide intervention: All participants had the same therapists for inpatient rehabilitation care, and NMES was administered by the same device (the article does not report who administered the device). MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of Upper Extremity component of the Fugl Meyer Assessment measure used: What outcome was measured? Motor function of the upper extremity, divided into proximal and distal components NR reliable? valid? NR When is the Assessed three times: at baseline, after 4 weeks of treatment, and at 4-4
measure used? week follow-up by the physical therapists Measure 2: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? ARAT Grasp, grip, pinch, gross movement NR NR Assessed three times: at baseline, after 4 weeks of treatment, and at 4- week follow-up by the physical therapists Measure 3: Click here to enter text. Name/type of Modified Ashworth Scale measure used: What outcome was Muscle tone of the biceps brachii and wrist flexors measured? NR reliable? valid? NR When is the measure used? Assessed three times: at baseline, after 4 weeks of treatment, and at 4- week follow up by the physical therapists Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. YES The physical therapists who took the three outcome measures at baseline, after 4 weeks of treatment, and at the 4-week follow-up were blinded to the group assignment. Recall or memory bias. Check yes, no, or NR, and if yes, explain. NO X Others (list and explain): RESULTS 5
List key findings based on study objectives Include statistical significance where appropriate (p<0.05) Include effect size if reported Forty participants completed the treatment and follow-up process, and no significant differences were found in the baseline characteristics of the groups. Statistically significant (p <.05) improvements were found in Fugl Meyer Assessment distal (FMA d) measure scores in the 12-hr NMES group, compared with the 30-min NMES group, at Week 4 (t = 2.89, p =.007) and at follow-up (t = 3.01, p =.003). Improvements in the FMA d were also found in the control group at Week 4 (t = 4.59, p =.000) and follow-up (t = 2.18, p =.04). There were also significant improvements in the Fugl Meyer Assessment proximal (FMA p) measure scores in the 12-hr NMES group, compared with the control group, at Week 4 (t = 2.78, p =.01) and at follow-up (t = 4.55, p =.000), but no significant difference was found between the two NMES groups on the FMA p measure. Although both the 12-hr and the 30-min NMES groups showed significant improvements on the ARAT measure at Week 4 and at follow-up, the difference on the ARAT between the two groups was statistically significant as well. On the Modified Ashworth Scale, no significant difference was found for the elbow and wrist flexors among the 12-hr NMES, 30-min NMES, and control groups at Week 4 or at follow-up. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. NO X In the conclusion, the authors revealed that a major limitation of the study was the small sample size. Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. YES X Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. YES X Was the percent/number of subjects/participants who dropped out of the study reported? YES X Limitations: What are the overall study limitations? 6
One limitations of this study is the small sample size, which occurred because the study was an initial assessment of the 12-hr NMES treatment program. Another limitation is the mixture of stroke types and levels of impairment at the subacute stages of stroke. CONCLUSIONS State the authors conclusions related to the research objectives. Compared with the group that received 30 min of NMES treatment daily, the group that received 12 hr of NMES treatment daily experienced more improvement of motor function in the affected upper extremity, especially in the wrist hand function, and limited improvement in spasticity. The findings of the study support the effectiveness of 12-hr NMES therapy, which can be a therapeutic method for patients at rest or asleep, on improving motor function recovery in the affected upper extremity, especially the distal upper extremity, after a stroke. Four weeks of 12-hr NMES treatment (with standard rehabilitative care) can improve motor control of the affected upper extremity in patients with hemiparesis after a stroke. Greater improvements were seen in the distal upper extremity. This work is based on the evidence-based literature review completed by Ananya Rudra, OTS, and Myka Winder, OTD, OTR/L, faculty advisor, University of Southern California. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. 7