Using 3D printed orthoses to improve hand function in stroke survivors
Development of Innovative Modular 3D-Printed Dynamic Orthoses: Application Programs for Hand Function Facilitation in Patients With Stroke
This study tests if using 3D printed hand braces along with regular therapy can help stroke survivors improve their hand function better than just therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Locations | 1 site (Tainan) |
| Trial ID | NCT06271187 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of modular 3D printed dynamic orthoses in enhancing upper limb function for stroke survivors. Participants will be randomly assigned to either a control group receiving traditional occupational therapy or an experimental group that combines this therapy with the use of the dynamic orthoses for home training. The intervention lasts for six weeks, followed by two follow-up assessments to evaluate the outcomes. The study is conducted at two medical centers in Taiwan.
Who should consider this trial
Good fit: Ideal candidates are stroke survivors who have experienced a stroke at least three months prior and have upper limb function within specific Brunnstrom stages.
Not a fit: Patients who have regained autonomous grasping function or have other neurological disorders affecting motor control may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hand function and rehabilitation outcomes for stroke survivors.
How similar studies have performed: While the use of 3D printed orthoses is a novel approach, similar interventions in stroke rehabilitation have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Onset of stroke at least three months ago; 2. Upper limb Brunnstrom stage II\~IV; 3. Shoulder can actively flex at least 45 degrees. Exclusion criteria: 1. Affected hand has regained autonomous grasping function, able to grasp and release a tennis ball 10 times within 2 minutes; 2. Joint deformity or stiffness in the affected hand that prevents the use of the dynamic orthosis; 3. Diagnosis of other neurological disorders affecting motor control, such as neglect, Parkinson's disease, etc.; 4. Inability to follow therapist guidance; 5. Currently undergoing other specific treatments affecting motor function recovery (such as rTMS and BTX).
Where this trial is running
Tainan
- National Cheng Kung University — Tainan, Taiwan (Recruiting)
Study contacts
- Principal investigator: JERHAO CHANG, PhD — National Cheng Kung University
- Study coordinator: Jerhao Chang
- Email: jerhao@ncku.edu.tw
- Phone: +886972272012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.