NCT05302141

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

April 28, 2023

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

March 20, 2022

Last Update Submit

April 27, 2023

Conditions

Nerve Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Box and block test (BBT)

    Change from Baseline at 2 weeks and 4 weeks

  • Grip power

    Change from Baseline at 2 weeks and 4 weeks

  • Hand function tasks

    Change from Baseline at 2 weeks and 4 weeks

  • Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)

    Change from Baseline at 4 weeks

  • General Health Questionnaire (GHQ-12)

    Change from Baseline at 4 weeks

  • +2 more secondary outcomes

Study Arms (2)

3D printing assistive device group

EXPERIMENTAL

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

Behavioral: Wear 3D printing assistive device

universal cuff groups

ACTIVE COMPARATOR

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

Behavioral: Wear universal cuff device

Interventions

Wear 3D printing assistive deviceBEHAVIORAL

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

3D printing assistive device group
Wear universal cuff deviceBEHAVIORAL

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

universal cuff groups

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Location

Related Publications (43)

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Study Officials

  • Hsinchieh Lee, master

    Taipei Medical University Shuang Ho Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2022

First Posted

March 31, 2022

Study Start

March 21, 2022

Primary Completion

September 20, 2022

Study Completion

September 20, 2022

Last Updated

April 28, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)