| [Objective]1. To develop laptop EMG and electrical stimulation guide injection device with independent property rights, make BTXA injection more accurate and effective.2. To popularize the product and achieve social economic benefits.[Method]1. After consulting a large number of relevant literatures,combining the technical parameters and using experience of low frequency pulse electrical stimulator and standard EMG guide injection device,we designed the product,then the prototype was manufactured.2. We compared both the parameters and EMG signal of the prototype by using a needle electrode in the same injection point with low frequency pulse electrical stimulator and standard electromyography apparatus.3. Clinical validation of parameters was implemented by adjusting the relative technical parameters of electrical stimulation current set resolution and duration of electrical stimulation.4. Final phase of clinical trial was taken on children with cerebral palsy that had lower limb spasticity.They were randomly divided into MyoGuide Group and Palpation Group,as the MyoGuide Group injecting botulinum toxin A with this MyoGuide device by less experienced physician,and the Palpation Group were injected without any device by experienced physician.Both groups injecting at several muscular sites.All the children underwent rehabilitation training on the next day.Before and3days,1week,1month,2months,3months after the injection,we got the injectors’ report,parents’ report,and measured the adductor angle,the hip flexor angle,the popliteal angle and the angle of ankle dorsi-flexion.Spastic muscles were measured with Modified Ashworth Scale.5. MyoGuide applied for Medical Device Registration Certificate and patent.6. Industrialized and popularized the product.[Result]1. In the study compared with low frequency pulse electrical stimulator,the stimulation parameters were basically coincident.Compared with standard electromyography apparatus,EMG signal was basically identical.Parameters after adjustment are more suitable for clinical BTXA injections.2. The results of final phase of clinical trial:①The experienced physician reported the uncertainty of the location of deep-sited and small muscles without any guidance;and the less experienced physician reported that EMG and electrical stimulation guided BTXA injections into deep-sited muscles,small muscles and dynamical dystonia were easier and more accurate.②Parents reported that BTXA came into effect at6-72hours after injection,peaked1-2weeks later and the effect lasted for about3months.③Spastic muscle MAS was significantly decreased3days after injection(P<0.05) and peaked at1month(P<0.001),than improved3months after injection,but it was still significantly decreased compared with pre-injection(P<0.05).④The improvement showed on PROM such as the adductor angle,the hip flexor angle,the popliteal angle and the angle of ankle dorsi-flexion was consistent with the change seen in MAS.3. The product obtained the Medical Device Registration Certificate of the People’s Republic of China,Shanghai Food and Drug Safety Machinery (quasi)2210521in2011.Patent is applying.4. At present the product has been industrialized and popularized to departments of major hospitals.Till now,5pieces have been sold.[Conclusion]1. Clinical study shown that BTXA injection guided by this device could accurately locate the spastic muscles,especially the deep-sited and small ones.MAS and PROM were significantly improved.Compared with Palpation Group, the angle of ankle dorsi-flexion impoved more in MyoGuide Group.2. This device is a new,economic,practical,accurate and effective treatment equipment in clinic,which is beneficial to the clinical popularization and achieves social economic benefits. |
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