| Purpose: The aim of the present study was to evaluate the effect of thermoplastic orthopedic insoles on gait in patients with hemiplegia by analyzing the combination of thermoplastic orthopedic insoles and conventional gait training compared with conventional gait training alone,so as to promote the clinical application of orthopedic aids and provide an effective and continuous program for gait rehabilitation of stroke patients with hemiplegia.Methods: A total of 50 subjects from outpatients and inpatients of rehabilitation department of Shanghai Xuhui Central Hospital(from July 2019 to July 2020)who met the requirements after screening were included in the study and randomly divided into the treatment group(n=25)and the control group(n=25).All patients underwent conventional gait training.During ambulation,sophisticated therapists performed manipulations to help patients suppress excessive muscle tension,stimulate muscle activity and promote normal movement patterns.In addition,patients received instructions about weight-shifting,involved limb weight-bearing,balance training and various intensive exercises,as functional activities(such as standing up from a chair,turning around,crossing obstacles).Both groups received 40-min training sessions each week for 4 weeks.Only patients in the experimental group were required to wear insoles for a minimum of 1 hour every day and recommended to continue wearing at 4 weeks follow-up after the completion of treatment,but it was not mandatory.The prescription formulation of insoles was based on gait observation,plantar pressure test(F-Scan?,Techstrom,Korea),and the use of the Najjarine Assessment System(NAS).The primary outcome measure was Tinetti Gait Scale(TGS)and the secondary outcome measures were the plantar pressure test,6-min walking test(6MWT),Lower Extremity Fugl-Meyer assessment(FMA-LE),Berg Balance Scale(BBS)and Barthel Index(BI).The main indicators and secondary indicators were tested twice before treatment and 4 weeks after treatment.In addition,the follow-up evaluation of the main indicator TGS was performed 4 weeks after treatment.Results:1.Comparison of the Tinetti Gait Scale(TGS)After 4 weeks of intervention and 4 weeks of follow-up after treatment,intra-group comparison showed that TGS of stroke patients in both groups was higher than that before treatment and there was a significant difference(P<0.01).Intergroup comparison showed that TGS improved more significantly in the experimental group than in the control group after 4 weeks of treatment(P = 0.014),and there was still a significant difference in TGS changes after 4 weeks of follow-up after treatment(P = 0.001).2.Comparison of the plantar pressure test2.1 Comparison of weight-bearing on the involved side and forefoot when standingAfter 4 weeks of intervention,intra-group comparison showed that weight-bearing on the involved side and forefoot(P <0.01)when standing in both groups were increased compared with before treatment,the difference was statistically significant.Compared with the control group,the experimental group also showed significant improvement in weight-bearing on the involved side(P = 0.012)and forefoot when standing(P = 0.028).2.2 Comparison of weight-bearing on the involved side and forefoot when walkingAfter 4 weeks of intervention,intra-group comparison showed that weight-bearing on the involved side and forefoot(P <0.01)when walking in both groups were increased compared with before treatment,the difference was statistically significant.Compared with the control group,the experimental group had more significant improvement in weight-bearing on the involved side(P = 0.016)and forefoot when walking(P = 0.043).2.3 Comparison of gait cycleAfter 4 weeks of intervention,intra-group comparison showed that early-stance phase(P<0.01),mid-stance phase(P<0.01)and late-stance phase(P<0.01)of stroke patients in the two groups were all improved compared with that before treatment,the difference was statistically significant.Compared with the control group,the experimental group had more significant improvement in the early-stance phase(P = 0.023)and mid-stance phase(P = 0.013)when standing,while there was no difference in the late-stance phase(P = 0.472).3.Comparison of 6-min walking testAfter 4 weeks of intervention,the intra-group comparison of 6MWT of stroke patients in 2 groups was higher than that before treatment(P<0.01),and the difference was statistically significant.However,there was no significant difference in improvement between the experimental group and the control group(P = 0.069).4.Comparison of Lower Extremity Fugl-Meyer assessmentAfter 4 weeks of intervention,the intra-group comparison of FMA-LE of stroke patients in the 2 groups was higher than that before treatment(P<0.01),and the difference was statistically significant.Compared with the control group,the improvement in the experimental group was more significant,and the difference was statistically significant(P = 0.029).5.Comparison of Berg Balance ScaleAfter 4 weeks of intervention,BBS of stroke patients in the 2 groups was increased compared with that before treatment(P<0.01),and the difference was statistically significant.The improvement in the experimental group was more significant than that in the control group,and the difference was statistically significant(P = 0.005).6.Comparison of Barthel IndexAfter 4 weeks of intervention,intra-group comparison showed that BI of stroke patients in 2 groups was increased compared with that before treatment(P<0.01),and the difference was statistically significant.Compared with the control group,the improvement in the experimental group was more significant,and the difference was statistically significant(P = 0.009).Conclusions:Thermoplastic orthopedic insoles combined with conventional gait training had great efficacy in enhancing gait performance,increasing weight-bearing on the involved side,improved gait cycle and its phases,better motor function of the lower limbs,balance and general ability in daily life than conventional gait training alone. |
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