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

NCT06716086 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-03-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06716086 on ClinicalTrials.gov