NCT06716086

A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Finger Proximal Interphalangeal Joint Contracture

Interventions

Type	Name	Description
OTHER	shape memory alloy-based orthosis	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.
OTHER	conventional stretching program	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.

Timeline

• Start date: 2025-03-12
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-12-04
• Last updated: 2025-03-17

Locations

1 site across 1 country: Taiwan