Effects of Interactive Dynamic Scalp Acupuncture on Motor Function and Gait of Lower Limbs after Stroke:A Multicenter,Randomized,Controlled Clinical Trial

Objective:To evaluate the effects of interactive dynamic scalp acupuncture(IDSA),simple combination therapy(SCT),and traditional scalp acupuncture(TSA)on motor function and gait of the lower limbs in post-stroke hemiplegia patients.Methods:A total of 231 patients with post-stroke hemiplegia was randomly divided into IDSA(78 cases),SCT(78 cases),and TSA(75 cases)groups by a random number table.Scalp acupuncture(SA)and lower-limb robot training(LLRT)were both performed in the IDSA and SCT groups.The patients in the TSA group underwent SA and did not receive LLRT.The treatment was administered once daily and 6 times weekly for 8 continuous weeks,each session lasted for 30 min.The primary outcome measures included Fugl-Meyer Assessment of the Lower Extremity(FMA-LE),Berg Balance Scale(BBS),Modified Barthel Index(MBI),and 6-min walking test(6 MWT).The secondary outcome measures included stride frequency(SF),stride length(SL),stride width(SW),affected side foot angle(ASFA),passive range of motion(PROM)of the affected hip(PROM-H),knee(PROM-K)and ankle(PROM-A)joints.The patients were evaluated before treatment,at 1-and 2-month treatment,and 1-,and 2-month follow-up visits,respectively.Adverse events during 2-month treatment were observed.Results:Nineteen patients withdrew from the trial,with 8 in the IDSA group,5 in the SCT group,and 6 in the TSA group.The FMA-LE,BBS,6 MWT and MBI scores in the IDSA group were significantly increased after 8-week treatment and2 follow-up visits compared with the SCT and TSA groups(P<0.05 or P<0.01).Compared with pre-treatment,the grade distribution of BBS and MBI scores in the 3 groups were significantly improved at 1,2-month treatment and 2 follow-up visits(P<0.05 or P<0.01).The SF,PROM-H,PFOM-K and PROM-A in the IDSA group was significantly increased compared with the SCT and TSA groups after 8-week of treatment(P<0.05 or P<0.01).Compared with the SCT group,ASFA of the IDSA group was significantly reduced after 8-week of treatment(P<0.05).SF,SL,PROM-K and PROM-A were significantly increased at the 2 nd follow-up visit whereas the ASFA was significantly reduced in the IDSA group compared with the SCT groups at 1 st follow-up visit(P<0.05 or P<0.01).The SF was significantly increased in the SCT group compared with the TSA group after 8-week treatment(P<0.05).Compared with the TSA group,PROM-K,PROM-A were significantly increased at the 2 nd follow-up visit(P<0.05).Conclusions:The effects of IDSA on lower-limb motor function and walking ability of post-stroke patients were superior to SCT and TSA.The SCT was comparable to TSA treatment,and appeared to be superior in improving the motion range of the lower extremities.(Registration No.ChiCTR1900027206)

Effect of Interactive Dynamic Scalp Acupuncture on Post-Stroke Cognitive Function,Depression,and Anxiety:A Multicenter,Randomized,Controlled Trial

Objective:To compare the clinical effects of interactive dynamic scalp acupuncture(IDSA),simple combination therapy(SCT),and traditional scalp acupuncture(TSA)on cognitive function,depression and anxiety in patients with post-stroke cognitive impairment.Methods:A total of 660 patients with post-stroke cognitive impairment who were admitted to 3 hospitals in Shenzhen City between May 2017 and May 2020 were recruited and randomly assigned to the IDSA(218 cases),SCT(222 cases)and TSA groups(220 cases)according to a random number table.All the patients received conventional drug therapy for cerebral stroke and exercise rehabilitation training.Scalp acupuncture and computer-based cognitive training(CBCT)were performed simultaneously in the IDSA group,but separately in the morning and in the afternoon in the SCT group.The patients in the TSA group underwent scalp acupuncture only.The course of treatment was 8 weeks.Before treatment(M0),1(M1)and 2 months(M2)after treatment,as well as follow-up at 1(M3)and 2 months(M4),the cognitive function of patients was assessed using the Mini-Mental State Examination(MMSE)and Montreal Cognitive Assessment Scale(MoCA)Scales;depression,anxiety,sleep quality,and self-care ability of patients were assessed using Hamilton Depression Rating Scale(HAMD),Hamilton Anxiety Rating Scale(HAMA),Pittsburgh Sleep Quality Index(PSQI),and Modified Barthel Index(MBI),respectively.During this trial,all adverse events(AEs)were accurately recorded.Results:There were no significant differences in the MMSE,MoCA,HAMD,HAMA,PSQI,and MBI scores among the 3 groups at M0(all P>0.05).In the IDSA group,the MMSE,MoCA and MBI scores from M2 to M4 were significantly higher than those in the SCT and TSA groups,while the HAMD,HAMA and PSQI scores were significantly reduced(all P<0.01).The changes of all above scores(M2–M0,M4–M0)were significantly superior to those in the SCT and TSA groups(all P<0.01,except M4–M0 of HAMD).At M2,the severity of MMSE,HAMD,HAMA,PSQI and MBI in the IDSA group was significantly lower than that in the SCT and TSA groups(all P<0.01).There was no serious AE during this trial.Conclusions:IDSA can not only significantly improve cognitive function,but also reduce depression,anxiety,which finally improves the patient's self-care ability.The effect of IDSA was significantly better than SCT and TSA。