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

T

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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