NCT06716086 A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness
| NCT ID | NCT06716086 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cheng-Kung University Hospital |
| Condition | Finger Proximal Interphalangeal Joint Contracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-03-12 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-03-12 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the applicability, effectiveness, and usability of a shape memory alloy-based orthosis for patients with finger proximal interphalangeal joint stiffness. This cutting-edge design incorporates shape memory alloy into the device for improving proximal interphalangeal joint stiffness and, secondarily, enhancing the ability to perform activities. Half of the participants will be assigned to experimental group, receiving a shape memory alloy-based orthosis for home program. The other half will be assigned to control group, receiving a conventional stretching program. Three evaluations, examining range of motion and hand functional performance, will be conducted before intervention, 4 weeks and 8 weeks after baseline by the researchers.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06716086 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Finger Proximal Interphalangeal Joint Contracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06716086 currently recruiting?
Yes, NCT06716086 is actively recruiting participants. Contact the research team at jkkuo@mail.ncku.edu.tw for enrollment information.
Where is the NCT06716086 trial being conducted?
This trial is being conducted at Tainan, Taiwan.
Who is sponsoring the NCT06716086 clinical trial?
NCT06716086 is sponsored by National Cheng-Kung University Hospital. The trial plans to enroll 90 participants.