A new orthosis for finger joint stiffness
A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness
This study is testing a new type of finger brace to see if it helps people with stiff finger joints move better compared to a regular stretching program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Locations | 1 site (Tainan, Taiwan) |
| Trial ID | NCT06716086 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and usability of a shape memory alloy-based orthosis designed for patients suffering from stiffness in the proximal interphalangeal joint of the fingers. Participants will be divided into two groups: one receiving the innovative orthosis for home use and the other following a conventional stretching program. The study will assess improvements in range of motion and hand function through evaluations conducted before the intervention and at 4 and 8 weeks post-baseline.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-79 with limited passive range of motion in the proximal interphalangeal joint due to past injuries or surgeries.
Not a fit: Patients with concurrent splint use, neurological disorders, or active infections affecting their fingers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve finger mobility and functionality for patients with joint stiffness.
How similar studies have performed: While the use of shape memory alloys in orthotic devices is innovative, similar studies have shown promise in improving joint function with advanced materials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-79 years old * Exhibit limitations in passive range of motion of the proximal interphalangeal joint, with extension less than 0 degrees or flexion less than 90 degrees. * Beyond the acute phase of the hand condition, and it has been more than 8 weeks post-surgery (or post-injury). Exclusion Criteria: * Concurrently use other types of splints for PIP joint stiffness. * Present with abnormal muscle tone, paralysis, or rigidity associated with central or peripheral nervous system dysfunction. * Suffer from complex regional pain syndrome or progressive degenerative disease affecting finger joints, such as rheumatoid arthritis. * Have an active infection or arthritis in their fingers. * Unable to follow instructions.
Where this trial is running
Tainan, Taiwan
- National Cheng-Kung University Hospital — Tainan, Taiwan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Li-Chieh Kuo, Ph.D
- Email: jkkuo@mail.ncku.edu.tw
- Phone: 886-62353535
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.