Actively Recruiting
A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness
Led by National Cheng-Kung University Hospital · Updated on 2025-03-17
90
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new shape memory alloy-based orthosis designed to help patients with stiffness in the finger proximal interphalangeal (PIP) joint. This device aims to improve joint stiffness and secondarily enhance the ability to perform daily activities. The study compares the new orthosis against a conventional stretching program in adults with PIP joint contracture who are beyond the acute phase of their hand condition. Participants are divided into two groups. One group uses the shape memory alloy-based orthosis during a home program involving 30-minute training sessions, 3-4 times daily, every day for 8 weeks. The other group follows a conventional stretching program with similar frequency and duration. The orthosis provides continuous force to the stiff joint using shape memory alloy as an elastic component, while the stretching program focuses on active and passive joint exercises. Participants will be evaluated three times: before starting treatment, at 4 weeks, and at 8 weeks after baseline. Assessments include measuring the range of motion and hand function using tests like the Minnesota Manual Dexterity Test, Purdue Pegboard Test, motion capture analysis, and a questionnaire on arm, shoulder, and hand disability. Usability of the orthosis will also be assessed after 8 weeks. The study duration for each participant is 8 weeks with ongoing monitoring of joint movement and hand performance.
CONDITIONS
Brief Title
A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 79 years
- Limitations in passive range of motion of the proximal interphalangeal joint, with extension less than 0 degrees or flexion less than 90 degrees
- More than 8 weeks post-surgery or post-injury and beyond the acute phase of the hand condition
You will not qualify if you...
- Currently using other types of splints for proximal interphalangeal joint stiffness
- Abnormal muscle tone, paralysis, or rigidity linked to central or peripheral nervous system dysfunction
- Complex regional pain syndrome or progressive degenerative disease affecting finger joints, such as rheumatoid arthritis
- Active infection or arthritis in fingers
- Unable to follow study instructions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants use either the shape memory alloy-based orthosis or perform a conventional stretching program at home to address proximal interphalangeal joint stiffness.
Home-based training program 3-4 times a day, 7 days a week
Trial Site Locations
Total: 1 location
1
National Cheng-Kung University Hospital
Tainan, Taiwan, Taiwan, 704
Actively Recruiting
Research Team
L
Li-Chieh Kuo, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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