A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness (NCT06716086) | Clinical Trial Compass
CompletedNot Applicable
A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness
Taiwan20 participantsStarted 2025-03-12
Plain-language 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.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Range Of Motion
Timeframe: Baseline, 4 weeks after baseline, and 8 weeks after baseline