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Objective <p>This study mainly aimed to compare the clinical efficacy of 3D-printed orthoses versus low-temperature thermoplastic plate orthoses(LTT)on wrist-hand flexor spasticity post-stroke.</p> Methods <p>Patients were stratified into three cohorts based on the Modified Ashworth Scale (MAS) grades (1,1+, and 2), with 60 patients per cohort. Patients in each cohort were randomized into treatment and control groups: MAS1 (3D, <i>n</i> = 23; control, <i>n</i> = 24); MAS1+ (3D, <i>n</i> = 24; control, <i>n</i> = 25); MAS2 (3D, <i>n</i> = 25; control, <i>n</i> = 26). Orthoses were worn 4–8&#xa0;h daily for 6 consecutive weeks, followed by a 6-week post-intervention follow-up. The primary outcome was MAS scores. Visual analogue scale(VAS), passive range of motion(PROM), Fugl-Meyer Assessment(FMA), and swelling scale (SS) scores were secondary outcomes, assessed at baseline, 6 weeks, and after 12 weeks.</p> Results <p>At 6 weeks, significant difference in the MAS scores were observed between groups: effective rates (ERs) were MAS1:71.4% vs. 30.8%, <i>p</i> = 0.006; MAS1+: 63% vs. 37%, <i>p</i> = 0.03. After 12 weeks, significant difference in MAS score changes persisted: ERs were MAS1: 66.7% vs. 33.3%, <i>p</i> = 0.029; MAS1+: 64.7% vs. 35.3%, <i>p</i> = 0.001. Significant difference was observed in the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) among the MAS1, MAS1+, and MAS2 cohorts (<i>p</i> &lt; 0.01).</p> Conclusion <p>3D-printed orthoses demonstrated superior efficacy to LTT orthoses in reducing mild-to-moderate (MAS 1, 1+) wrist-hand flexor spasticity post-stroke. For severe spasticity (MAS 2), further optimization of material properties and scanning technology may be necessary.</p> Trial registration <p>ChiCTR-INR-2,300,070,454 (Registered: 4 December 2023).</p>

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Therapeutic efficacy of 3 dimensions printed orthoses on wrist-hand flexor spasticity in post-stroke hemiplegia: a multi-center stratified clinical study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月30日

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  • Gaiyan Li,
  • Yanmin Wang,
  • Cuibin Tang,
  • Shu Deng,
  • Jie Shen,
  • Yuqing Bi,
  • Ying Xu,
  • Ying Zhang

摘要

Objective

This study mainly aimed to compare the clinical efficacy of 3D-printed orthoses versus low-temperature thermoplastic plate orthoses(LTT)on wrist-hand flexor spasticity post-stroke.

Methods

Patients were stratified into three cohorts based on the Modified Ashworth Scale (MAS) grades (1,1+, and 2), with 60 patients per cohort. Patients in each cohort were randomized into treatment and control groups: MAS1 (3D, n = 23; control, n = 24); MAS1+ (3D, n = 24; control, n = 25); MAS2 (3D, n = 25; control, n = 26). Orthoses were worn 4–8 h daily for 6 consecutive weeks, followed by a 6-week post-intervention follow-up. The primary outcome was MAS scores. Visual analogue scale(VAS), passive range of motion(PROM), Fugl-Meyer Assessment(FMA), and swelling scale (SS) scores were secondary outcomes, assessed at baseline, 6 weeks, and after 12 weeks.

Results

At 6 weeks, significant difference in the MAS scores were observed between groups: effective rates (ERs) were MAS1:71.4% vs. 30.8%, p = 0.006; MAS1+: 63% vs. 37%, p = 0.03. After 12 weeks, significant difference in MAS score changes persisted: ERs were MAS1: 66.7% vs. 33.3%, p = 0.029; MAS1+: 64.7% vs. 35.3%, p = 0.001. Significant difference was observed in the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) among the MAS1, MAS1+, and MAS2 cohorts (p < 0.01).

Conclusion

3D-printed orthoses demonstrated superior efficacy to LTT orthoses in reducing mild-to-moderate (MAS 1, 1+) wrist-hand flexor spasticity post-stroke. For severe spasticity (MAS 2), further optimization of material properties and scanning technology may be necessary.

Trial registration

ChiCTR-INR-2,300,070,454 (Registered: 4 December 2023).