Clinical trial NCT05302141: Effects of Assistive Device on ADL Function in Patients With Nerve Injury
Official title: Effects of 3D Printing Assistive Device on ADL Function in Patients With Nerve Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Injury
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
Collaborators: name: Sponsor GmbH
First posted: 2022-03-31
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Active joint range of motion of shoulder and elbow
timeFrame: Change from Baseline at 2 weeks and 4 weeks
Secondary outcomes:
measure: Box and block test (BBT)
timeFrame: Change from Baseline at 2 weeks and 4 weeks
measure: Grip power
timeFrame: Change from Baseline at 2 weeks and 4 weeks
measure: Hand function tasks
timeFrame: Change from Baseline at 2 weeks and 4 weeks
measure: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
timeFrame: Change from Baseline at 4 weeks
measure: General Health Questionnaire (GHQ-12)
timeFrame: Change from Baseline at 4 weeks
measure: Daily wearing activity record sheet
timeFrame: Every training session during 8 sessions, total sessions continued to 4 weeks
measure: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
timeFrame: The end of the study at 4 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Hsinchieh Lee, master
role: PRINCIPAL_INVESTIGATOR
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