Clinical Application Of Instructional Functional Electrical Stimulation(IFES) In Early Hemiplegia After Stroke

Objective1. To assess the efficacy of Instructional functional electrical stimulation(IFES) primarily in early hemiplegia after stroke.2. To assess the safety of IFES primarily in early hemiplegia after stroke.MethodsA randomized block, controlled, open, parallel-group trial was undertaken. During the recruitment period(October 1, 2007 to March 31, 2008), hemiplegic patients with early stroke were put in blocks of four according to stroke subtype (cerebral ischemia and hemorrhage) and age (40 to 60, and 61 to 80) after signing informed consent. The four members of each block were then randomly assigned to each of the four treatment groups receiving IFES and routine internal medicine and rehabilitation treatments(RT), traditional electrical stimulation(TES) and RT, electromyogram-triggered neuromuscular stimulation(ETNS) and RT, or RT only (control). Subjects in IFES, TES and ETNS groups were given a 20-day program of electrical stimulation to the extensor muscles of wrist(20 minutes, once daily) via surface electrodes. All subjects were assessed with Brunnstrom stage classification, upper extremity Fugl-Meyer scores, manual muscle test(MMT), modified Ashworth scale(MAS), functional comprehensive assessment (FCA), and Hamilton depression rating scale(HAMD) at the time of admission, the 10^th day and the 20^th day after admission. Their heart rate, blood pressure and laboratory tests involving blood routine, liver function and nephric function were detected at the time of admission and the 20^th day after admission. The adverse reactions were recorded at every 20-day visit. Outcome measurements were analyzed with chi squared tests or related samples test using SPSS(version 11.5) to compare the main effects before, during and after treatment, as well as the treatment effects among the 4 groups.Results28 subjects were admitted in the study of efficacy, and one did not complete the study. Groups were well matched for age, gender, course of stroke, side of upper limb impairment, and stroke subtype.There was a statistically significant increase in upper extremity Fugl-Meyer scores, and MMT for elbow flexors and wrist flexors in the IFES group (P<0.05) . There were no significant differences in their Brunnstrom stage classification, MMT for shoulder adductors and abductors, elbow extensors, wrist extensors, finger flexors and extensors or MAS (P>0.05). There was a statistically significant increase in Brunnstrom stage classification (upper extremity), upper extremity Fugl-Meyer scores, and MMT for shoulder and elbow in the ETNS group (P<0.05) . There were no statistically significant differences in their Brunnstrom stage classification (hand) , MMT for wrist or finger, or MAS for their upper extremity (P>0.05) . There were no statistically significant differences in Brunnstrom stage classification, Fugl-Meyer scores, MMT or MAS for upper extremity in either the TES group or the control group. The margin between the upper extremity Fugl-Meyer scores 20 days after admission and the time of admission of the ETNS group was best, and the margin of the IFES group was better than those of other two groups with no significant differences (P>0.05).There were statistically significant increases in the cognition section's evaluation scores of the scale of FCA for IFES, TES and ETNS groups after 20-day therapy (P<0.05) , but no significant differences in control group (P>0.05) . The cognition margin between 20 days after admission and the time of admission in the ETNS group was best, and the margin of the IFES group was better than those of other two groups with no significant differences (P>0.05).The HAMD margin between the time of admission and 20 days after admission in the control group was best, and the margin of the TES group was better than those of other two groups with no significant differences (P>0.05).There was an statistically significant increase in FCA scores for each group after 20-day therapy (P<0.05) . The FCA margin between 20 days after admission and the time of admission in the ETNS group was best, and the margin of the IFES group was better than those of other two groups with no significant differences (P>0.05).28 subjects were admitted in the study of safety, and 5 subjects did not complete the study. There were no statistically significant differences in heart rate, blood pressure, blood routine liver function or nephric function of four groups before and after 20-day therapy (P>0.05). 9 adverse reactions were recorded in the study, and none of them was related to RR.Conclusion1. IFES could enhance the upper extremity functional recovery in early hemiplegia after stroke. The efficacy was similar to ETNS, and better than TES.2. IFES could promote cognitive function in early stroke patients. The efficacy was similar to ETNS, and would be better than TES.3. The more cognitive function was improved, the more depression would be in early hemiplegia after stroke.4. IFES could promote function independence in early stroke patients. The efficacy would be close to ETNS, and better than TES.5. IFES applied in early stroke patients is safe, as well as TES and ETNS.