Design of Personalized Cervical Fixation Orthosis Based on 3D Printing Technology

Xu, Yangyang; Li, Xiangyu; Chang, Yafei; Wang, Yi; Che, Lifang; Shi, Guopeng; Niu, Xiaofen; Wang, Haiyan; Li, Xiaohe; He, Yujie; Pei, Baoqing; Wei, Guoqiang

doi:10.1155/2022/8243128

Cited by 10 publications

(2 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The splint has an innovative clamshell design, incorporating a hinge on one side that allows the thumb and cuff sections to be opened and closed, maximizing the individual's ability to don and doff without assistance. The use of 3Dprinted rigid plastic components, rather than fabric or other soft materials, provides mechanical support and enables dynamic grasp properties, which are particularly relevant for individuals with spasticity (e.g., excessive tone) [39].…”

Section: Methodsmentioning

confidence: 99%

The NuroSleeve, A User-Centered 3D Printed Orthosis and Functional Electrical Stimulation System for Individuals with Upper Extremity Impairment

Khantan

Avery²,

Aung

et al. 2023

Preprint

View full text Add to dashboard Cite

Background: Active upper extremity (UE) assistive devices have the potential to restore independent functional movement in individuals with UE impairment due to neuromuscular diseases or injury-induced chronic weakness. Academically fabricated UE assistive devices are not usually optimized for Activities of Daily Living (ADLs), whereas commercially available alternatives are prohibitively expensive. Both options are typically difficult to don and doff and are cumbersome for extensive daily use. To overcome these limitations, we have designed, developed, and clinically validated the NuroSleeve, an innovative user-centered UE orthosis. Methods: This study introduces the design, implementation, and clinical evaluation of the NuroSleeve, a user-centered, lightweight, affordable, easy to don and doff 3D-printed UE active orthosis for improving function and independence in individuals living with UE neuromuscular impairment. Our primary goals are to develop a customized active UE brace that individuals with UE impairment can use to perform ADLs and to evaluate the benefits of incorporating the device into occupational therapy sessions. The trial is designed as a prospective, open-label, single-cohort feasibility study of eight-week sessions combined with at-home use of the device and implements an iterative device design process where feedback from participants and therapists inform future design improvements. Results: All participants learned how to independently don, doff, and use the NuroSleeve in ADLs, both in clinical therapy and in their home environments. All participants showed improvements in their Canadian Occupational Performance Measure (COPM), which was the primary clinical trial outcome measure. Furthermore, the participants and therapists provided valuable feedback to guide further development. Conclusions: Our results from non-clinical testing and clinical evaluation demonstrate that the NuroSleeve has met performance and safety requirements and effectively improves independent voluntary function during ADLs. The study’s encouraging preliminary findings indicate that the NuroSleeve has met its technical and clinical objectives while improving on the limitations of the existing UE orthoses due to its personalized and flexible approach to hardware and firmware design. Trial Registration: ClinicalTrials.gov identifier: NCT04798378, https://clinicaltrials.gov/ct2/show/NCT04798378, date of registration: March 15, 2021.

show abstract

Section: Methodsmentioning

confidence: 99%

The NuroSleeve, A User-Centered 3D Printed Orthosis and Functional Electrical Stimulation System for Individuals with Upper Extremity Impairment

Khantan

Avery²,

Aung

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

“…The splint has an innovative clamshell design, incorporating a hinge on one side that allows the thumb and cuff sections to be opened and closed, maximizing the individual’s ability to don and doff without assistance. The use of 3D-printed rigid plastic components rather than fabric or other soft materials, provides mechanical support and enables dynamic grasp properties, which are particularly relevant for individuals with spasticity (e.g., excessive tone) [ 53 ]. The NuroSleeve also integrates an external FES unit that can generate functional movement by directly stimulating muscles.…”

Section: Methodsmentioning

confidence: 99%

The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment

Khantan

Avery

Aung

et al. 2023

J NeuroEngineering Rehabil

View full text Add to dashboard Cite

Background Active upper extremity (UE) assistive devices have the potential to restore independent functional movement in individuals with UE impairment due to neuromuscular diseases or injury-induced chronic weakness. Academically fabricated UE assistive devices are not usually optimized for activities of daily living (ADLs), whereas commercially available alternatives tend to lack flexibility in control and activation methods. Both options are typically difficult to don and doff and may be uncomfortable for extensive daily use due to their lack of personalization. To overcome these limitations, we have designed, developed, and clinically evaluated the NuroSleeve, an innovative user-centered UE hybrid orthosis. Methods This study introduces the design, implementation, and clinical evaluation of the NuroSleeve, a user-centered hybrid device that incorporates a lightweight, easy to don and doff 3D-printed motorized UE orthosis and a functional electrical stimulation (FES) component. Our primary goals are to develop a customized hybrid device that individuals with UE neuromuscular impairment can use to perform ADLs and to evaluate the benefits of incorporating the device into occupational therapy sessions. The trial is designed as a prospective, open-label, single-cohort feasibility study of eight-week sessions combined with at-home use of the device and implements an iterative device design process where feedback from participants and therapists informs design improvement cycles. Results All participants learned how to independently don, doff, and use the NuroSleeve in ADLs, both in clinical therapy and in their home environments. All participants showed improvements in their Canadian Occupational Performance Measure (COPM), which was the primary clinical trial outcome measure. Furthermore, participants and therapists provided valuable feedback to guide further development. Conclusions Our results from non-clinical testing and clinical evaluation demonstrate that the NuroSleeve has met feasibility and safety goals and effectively improved independent voluntary function during ADLs. The study’s encouraging preliminary findings indicate that the NuroSleeve has met its technical and clinical objectives while improving upon the limitations of the existing UE orthoses owing to its personalized and flexible approach to hardware and firmware design. Trial Registration: ClinicalTrials.gov identifier: NCT04798378, https://clinicaltrials.gov/ct2/show/NCT04798378, date of registration: March 15, 2021.

show abstract

Design and Finite Element Analysis of a Custom Wrist Orthosis for 3D Printing Containing Ventilation Areas and Wrist Protection Zones Achieved by Topological Optimization

Bandosz,

Rychlik

2024

Lecture Notes in Mechanical Engineering

View full text Add to dashboard Cite

Design of Personalized Cervical Fixation Orthosis Based on 3D Printing Technology

Cited by 10 publications

References 35 publications

The NuroSleeve, A User-Centered 3D Printed Orthosis and Functional Electrical Stimulation System for Individuals with Upper Extremity Impairment

The NuroSleeve, A User-Centered 3D Printed Orthosis and Functional Electrical Stimulation System for Individuals with Upper Extremity Impairment

The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment

Design and Finite Element Analysis of a Custom Wrist Orthosis for 3D Printing Containing Ventilation Areas and Wrist Protection Zones Achieved by Topological Optimization

Contact Info

Product

Resources

About