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

Taipei Medical University

Status: Completed

Conditions: Nerve Injury

Treatments: Behavioral: Wear 3D printing assistive device; Behavioral: Wear universal cuff device

Study type: Interventional

Funder types: Other

Identifiers

NCT05302141

N202201010

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The medical record shows the diagnosis of central or peripheral nerve injury, and the onset is more than three months
• Able to understand wearing operation instructions and have the ability to give informed consent
• Able to control shoulder lifting and bending elbows, but difficult to grasp tools

Exclusion criteria

• Older than 75 years old and younger than 20 years old
• Severe visual or hearing impairment
• Suffering from other neurological, cardiopulmonary, or musculoskeletal diseases that affect the subject to perform the actions required by this test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

3D printing assistive device group

Experimental group

Description:

experimental (3D printing assistive device) groups for 4 weeks of treatment (thirty minutes a time, twice a week).

Treatment:

Behavioral: Wear 3D printing assistive device

universal cuff groups

Active Comparator group

Description:

control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week).

Treatment:

Behavioral: Wear universal cuff device