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Completed

NCT Number: NCT05302141

Effects of 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.

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Key information

Conditions

Nerve Injury

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wear 3D printing assistive device

Behavioral

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

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Collaborators

  • Sponsor GmbH

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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