NCT05302141

Effects of Assistive Device on ADL Function in Patients With Nerve Injury

Effects of 3D Printing Assistive Device on ADL Function in Patients With Nerve Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Taipei Medical University Shuang Ho Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Our study is aimed to evaluate the effect of 3D printing assistive device on hand function for patients with neural injury.

Detailed description

Background: Injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of daily life. The use of assistive devices can assist functional activities and reduce the phenomenon of non-use. 3D printing technology was used to construct personalized, complicated orthosis, and one piece to reduce assembly time. But the evidence most are product development, but few of study investigate the effectiveness and it cannot be widely used for hand injuries. Aim: To evaluate the effect of 3D printing assistive device on hand function for patients with neural injury. Methods: Thirty neural injury patients were recruited and randomized into experimental (3D printing assistive device) or control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week). The performance was assessed by a blinded assessor included Active Range of motion (AROM), Box and block test, Grip dynamometer, upper extremity task, Disability of the arm, shoulder and hand questionnaire(DASH), General Health Questionnaire(GHQ-12) and Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). The practice performance and adverse effect were recorded. Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05. Keywords: Neural injury, 3D printing, assistive device, hand function.

Conditions

• Nerve Injury

Interventions

Type	Name	Description
BEHAVIORAL	Wear 3D printing assistive device	Wear 3D printing aids and engage in functional tasks, including eating, typing, and writing. At home: use daily, 30 minutes each time; Treatment room: 30 minutes twice a week
BEHAVIORAL	Wear universal cuff device	Wear universal cuff aids and engage in functional tasks, including eating, typing, and writing. At home: use daily, 30 minutes each time; Treatment room: 30 minutes twice a week

Timeline

• Start date: 2022-03-21
• Primary completion: 2022-09-20
• Completion: 2022-09-20
• First posted: 2022-03-31
• Last updated: 2023-04-28

Locations

1 site across 1 country: Taiwan