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

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.

Study Overview

• Status: Recruiting
• Conditions: Finger Proximal Interphalangeal Joint Contracture
• Intervention / Treatment: Other: shape memory alloy-based orthosis; Other: conventional stretching program

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li-Chieh Kuo, Ph.D; Phone Number: 5908 886-62353535; Email: jkkuo@mail.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng-Kung University Hospital
    • Contact: Li-Chieh Kuo, Ph.D; Phone Number: 5908 886-62353535; Email: jkkuo@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMA group; Participants in the SMA group will use the shape memory alloy-based orthosis. They will undergo a 30-minute home-based training program 3-4 times a day, 7 days a week, for 8 weeks.	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.
Active Comparator: Stretching group; Participants in the Stretching group will receive conventional stretching program as a home program. They will undergo a 30-minute home-based training program 3-4 times a day, 7 days a week, for 8 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range Of Motion	Active, passive and torque range of motion are common measurements to assess joint mobility limitations in clinical settings. Active range of motion is measured as the maximum movement achieved by the patient's own efforts. Passive range of motion is measured when an external force, such as a therapist, moves the joint until the end feel is detected. Torque range of motion is assessed with a specific tension applied to the movement of interest. Normal proximal interphalangeal joint flexion range of motion typically ranges from 0-100 or 110 degrees.	Baseline, 4 weeks after baseline, and 8 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minnesota Manual Dexterity Test	The Minnesota Manual Dexterity Test assesses fine manual dexterity and consists of two subtests: the placing and turning tests. These involve hand movements such as picking up, turning, transferring, and placing disks. Each subtest includes two trials, resulting in a total of six trials. The combined time taken to complete both trials in each subtest will be recorded.	Baseline, 4 weeks after baseline, and 8 weeks after baseline
Purdue Pegboard Test	The Purdue Pegboard Test assesses fine motor coordination and manipulative ability through four subtests: dominant hand, non-dominant hand, both hands, and assembly. In each subtest, participants place as many pins as possible in the designated column, with the assembly subtest also incorporating washers and collars. The allotted time is thirty seconds for the dominant hand, non-dominant hand, and both hands subtests, and sixty seconds for the assembly subtest. Each subtest is repeated three times, and the average of these three trials is calculated as the final score.	Baseline, 4 weeks after baseline, and 8 weeks after baseline
Motion Capture and Analysis System	The motion capture system will be used to measure the functional range of motion of the hand. It utilizes standard cameras or Vicon motion capture system to record hand movements of participants. The data is further analyzed using tools such as MATLAB, Mediapipe, or other motion analysis software to assess the functional range of motion of the hand.	Baseline, 4 weeks after baseline, and 8 weeks after baseline
The Disability of the Arm, Shoulder and Hand Questionnaire, Taiwan version	The Taiwan version of the Disability of the Arm, Shoulder, and Hand Questionnaire is a 30-item, self-reported tool used to assess hand function, specifically addressing physical function and symptoms in patients with upper limb musculoskeletal disorders. It provides a detailed view of patient disability and tracks changes in symptoms and function over time. Each item is scored on a 5-point Likert scale, where 1 represents no difficulty and 5 represents inability to perform the task. Responses are based on the patient's experiences from the past week, with scores converted to a 0-100 scale, where higher scores indicate greater severity of disability.	Baseline, 4 weeks after baseline, and 8 weeks after baseline
System Usability Scale	The System Usability Scale assesses the usability of the SMA-based orthosis. It evaluates effectiveness and satisfaction from the user's subjective perspective. The scale contains 10 items, each with five response options, where 1 means "Strongly disagree" and 5 means "Strongly agree". Participants' scores for each item are converted to range from 0 to 4. For items 1,3,5,7, and 9, the converted score is the participant's scores minus 1. For items 2,4,6,8 and 10, the converted score is 5 minus the participant's scores. The sum of these scores is then multiplied by 2.5 to obtain the overall usability value.	8 weeks after baseline

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: joint contracture; hand injury; joint range of motion; shape memory alloy; finger stiffness
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Joint Diseases; Contracture
• Other Study ID Numbers: A-ER-113-251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No