A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness
National Cheng-Kung University Hospital
90 participants
Mar 12, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- -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 Criteria5
- 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.
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Interventions
The home program with the shape memory alloy-based orthosis contains warm-up part and correction part. The SMA-based orthosis is an improvement over traditional dynamic splint. This corrective device uses shape memory alloy as an elastic component specifically designed to address finger joint stiffness. It provides continuous force for stiff joint in order to address stiffness.
The home program for the stretching group includes active joint range of motion exercises and passive stretching exercises. Participants will follow instructions to perform various joint movements, with a focus on their restricted fingers.
Locations(1)
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NCT06716086