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

April 27, 2023 updated by: Taipei Medical University Shuang Ho Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Taipei Medical University Shuang Ho Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D printing assistive device group
experimental (3D printing assistive device) groups for 4 weeks of treatment (thirty minutes a time, twice a week).
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
Active Comparator: universal cuff groups
control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active joint range of motion of shoulder and elbow
Time Frame: Change from Baseline at 2 weeks and 4 weeks
use a goniometer to measure the active joint movements of the shoulder and elbow, including shoulder flexion, abduction, external rotation , internal rotation, and elbow flexion angle.
Change from Baseline at 2 weeks and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and block test (BBT)
Time Frame: Change from Baseline at 2 weeks and 4 weeks
Assess grasping, transporting, and releasing small blocks, and count the number of blocks the individual moves 1 inch to the opposite side of the box in one minute.
Change from Baseline at 2 weeks and 4 weeks
Grip power
Time Frame: Change from Baseline at 2 weeks and 4 weeks
use the Jamar Dynamometer (Asimow Engineering Co., CA, USA) grip strength device to test, ask the individual to bend the elbow and shoulder adduct, and hold the grip strength device firmly, and measure the average 3 times in total
Change from Baseline at 2 weeks and 4 weeks
Hand function tasks
Time Frame: Change from Baseline at 2 weeks and 4 weeks
Complete the tasks of writing, spoon, and typing. The writing task is based on the writing sub-item of the Basic Literacy Test, and the individual is asked to write a short sentence, the content is 25 words, count the number of words in two minute; spoon task, ask the client to use a spoon to scoop five kidney beans into a can, and count the seconds it takes; one-minute typing test (https://typing.tw/), to see the number of words typed in one minute with the correct rate.
Change from Baseline at 2 weeks and 4 weeks
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Time Frame: Change from Baseline at 4 weeks
The first and second subscales are used. To evaluate the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale., which are converted into 100 points. The higher the score, the higher the severity.
Change from Baseline at 4 weeks
General Health Questionnaire (GHQ-12)
Time Frame: Change from Baseline at 4 weeks
Self-rating scale used to measure mental health status. Respondents rated the frequency of occurrence of each item in the past month on a scale of 0 (not at all) to 3 (often). The total score can be up to 36 points, and a score of 15 or more can be defined as mental distress. The higher the score, the more serious the distress.
Change from Baseline at 4 weeks
Daily wearing activity record sheet
Time Frame: Every training session during 8 sessions, total sessions continued to 4 weeks
To record the daily wearing and practice time, the number of side effects, such as soreness, pain, injury, etc.
Every training session during 8 sessions, total sessions continued to 4 weeks
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time Frame: The end of the study at 4 weeks
The questionnaire is a subjective self-administered scale for the use of assistive devices, with a 5-point scale (strongly agree to strongly disagree), including beauty, complexity, weight , resistance, comfort, easy to wear, etc.
The end of the study at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Collaborators

Sponsor GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Actual)

September 20, 2022

Study Completion (Actual)

September 20, 2022

Study Registration Dates

First Submitted

March 20, 2022

First Submitted That Met QC Criteria

March 20, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202201010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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