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

Nerve Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05302141
• Other study ID #: N202201010
• Status: Completed
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: September 20, 2022

Study information

• Verified date: February 2022
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nerve Injury
• Wounds and Injuries

Intervention

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
• 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

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital	Sponsor GmbH

Country where clinical trial is conducted

Taiwan, 

References & Publications (43)

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline at 2 weeks and 4 weeks
Secondary	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.	Change from Baseline at 2 weeks and 4 weeks
Secondary	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	Change from Baseline at 2 weeks and 4 weeks
Secondary	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.	Change from Baseline at 2 weeks and 4 weeks
Secondary	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.	Change from Baseline at 4 weeks
Secondary	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.	Change from Baseline at 4 weeks
Secondary	Daily wearing activity record sheet	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
Secondary	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.	The end of the study at 4 weeks