Implementation, testing and pilot clinical evaluation of superelastic splints that decrease joint stiffness.

The present work aims at demonstrating that a customised choice of shape memory alloy (SMA) composition, thermo-mechanical treatment and shaping can lead to effective rehabilitation devices applicable to sub-acute and chronic spastic paresis in paediatric patients. SMA pseudoelasticity is regarded as a means to implement a corrective action on posture without hindering residual voluntary or reflex mobility of the affected limb. Specific hinges containing NiTi or NiTiNb elements were designed and constructed to transfer pseudoelastic recovery force to fitted splints for the elbow or the ankle joint. The devices were mechanically tested and showed complete stability after 20-100 cycles, and unchanged characteristics after 1000 full-range deflections. Repositioning splints equipped with patient-specific pseudoelastic hinges were prescribed to 25 individuals (aged 7.75 ± 5.40 years) with mild to severe spastic tetraparesis. Clinical and instrumental evaluations were carried out during crossover trials with traditional and pseudoelastic splints. The sequence of treatment steps was randomized for each subject. The results show that, compared to fixed-angle braces, pseudoelastic devices decrease passive joint stiffness while providing the same control on limb posture. Dynamic pseudoelastic braces are therefore an innovative treatment for spastic paresis, which may reduce joint stiffness.

RCT Entities:   Population Interventions Outcomes