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)