| 1.Background and PurposeStroke is a disease with high morbidity,high mortality,and high disability rate.About 70%of surviving patients after stroke have left upper limb dysfunction,especially wrist and hand dysfunction.Previous studies have confirmed that if the wrist orthosis is combined with conventional rehabilitation training,the rehabilitation effect is more significant.However,no scholars have yet explored the efficacy of traditional compound wrist orthopedic adjuvant therapy in patients with wrist and hand dysfunction during the recovery period of stroke.Therefore,this study intends to observe the efficacy of compound wrist-hand orthosis-assisted therapy on wrist-hand dysfunction in patients with convalescent stroke.In addition,in recent years,some scholars have begun to try to apply 3D printing technology to wrist orthosis,but there has not been a standardized design and manufacturing process.Therefore,this study intends to combine 3D scanning,inverse modeling and 3D printing technology to further explore the design and manufacturing process of 3D printed wrist-hand orthosis and the feasibility of stroke patients to provide a basis for its clinical application.2.Subjects and methodsThe First TrialFrom June 2018 to December 2019,34 stroke patients were divided into the experimental group(n=17)and the control group(n=17)using a random number table method.Both groups received basic treatment and conventional manual operation treatment.On this basis,the experimental group wore a compound wrist-hand orthosis during and after the daily manual operation treatment.The routine manual occupational treatment was carried out 30 minutes every time,two times a day for 14 days,and the non-training time orthosis wearing was carried out cumulative five hours a day for 14 days.Before and after treatment,the Brunnstrom scale(upper limb and hand)and Fugl-Meyer Assessment scale(FMA)(wrist and hand)were used to assess the motor function of the upper limbs and hands while the Modified Ashworth Scale(MAS)and Barthel Index(BI)were separately used to assess the wrist tension and activities of daily living(ADL).The Second TrialFirst of all,the contralesional upper limb of stroke patients was scanned by a hand-held body surface 3D scanner.Secondly,a series of inverse reconstructions were performed on the original point cloud data which were collected in the above step.Then,we used two types of printing techniques,Fused Deposition Modeling(FDM)and Stereo Lithography Appearance(SLA),to manufacture the wrist-hand orthosis model.At last,Quebec User Evaluation of Satisfaction with Assistive Technology was used to evaluate the satisfaction of the stroke patients with these two kind of orthoses.3.Results3.1 The First TrialTwo cases dropped out in the control group.There were no significant difference Brunnstrom stage,FMA score,MAS stage,and BI score between two groups before treatment(P>0.05).After treatment,the scores of FMA and BI scores significantly improved in both groups(|Z|>3.420,P<0.01),and the improvement were higher in the experimental group than in the control group(Z=-2.895,t=4.331,P<0.01);while,no significant difference was found in the Brunnstrom stage and MAS stage in both groups(P>0.05).3.2 The Second TrialPatients’ satisfaction of SLA-printed orthosis was higher than that of FDM-printed orthosis in total,especially in the aspects of easy to adjust,safety,durability and comfort.4.Conclusion4.1 The compound wrist-hand orthosis-assisted therapy could significantly promote the improvement of wrist-hand motor function and activities of daily living in patients with convalescent stroke.4.2 The digital design and manufacturing process of 3D printed wrist-hand orthosis has a certain of feasibility in stroke patients and SLA is more promising for future application on rehabilitation orthosis than FDM. |