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

Primary Purpose

Nerve Injury

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Wear 3D printing assistive device
Wear universal cuff device
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Injury

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Taipei Medical University Shuang Ho Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3D printing assistive device group

universal cuff groups

Arm Description

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

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

Outcomes

Primary Outcome Measures

Active joint range of motion of shoulder and elbow
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.

Secondary Outcome Measures

Box and block test (BBT)
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.
Grip power
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
Hand function tasks
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.
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
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.
General Health Questionnaire (GHQ-12)
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.
Daily wearing activity record sheet
To record the daily wearing and practice time, the number of side effects, such as soreness, pain, injury, etc.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
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.

Full Information

First Posted
March 20, 2022
Last Updated
April 27, 2023
Sponsor
Taipei Medical University Shuang Ho Hospital
Collaborators
Sponsor GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05302141
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
Collaborators
Sponsor GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D printing assistive device group
Arm Type
Experimental
Arm Description
experimental (3D printing assistive device) groups for 4 weeks of treatment (thirty minutes a time, twice a week).
Arm Title
universal cuff groups
Arm Type
Active Comparator
Arm Description
control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week).
Intervention Type
Behavioral
Intervention Name(s)
Wear 3D printing assistive device
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Wear universal cuff device
Intervention Description
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
Primary Outcome Measure Information:
Title
Active joint range of motion of shoulder and elbow
Description
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.
Time Frame
Change from Baseline at 2 weeks and 4 weeks
Secondary Outcome Measure Information:
Title
Box and block test (BBT)
Description
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.
Time Frame
Change from Baseline at 2 weeks and 4 weeks
Title
Grip power
Description
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
Time Frame
Change from Baseline at 2 weeks and 4 weeks
Title
Hand function tasks
Description
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.
Time Frame
Change from Baseline at 2 weeks and 4 weeks
Title
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Description
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.
Time Frame
Change from Baseline at 4 weeks
Title
General Health Questionnaire (GHQ-12)
Description
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.
Time Frame
Change from Baseline at 4 weeks
Title
Daily wearing activity record sheet
Description
To record the daily wearing and practice time, the number of side effects, such as soreness, pain, injury, etc.
Time Frame
Every training session during 8 sessions, total sessions continued to 4 weeks
Title
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Description
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.
Time Frame
The end of the study at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsinchieh Lee, master
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Assistive Device on ADL Function in Patients With Nerve Injury

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