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

National Cheng-Kung University

Status: Enrolling

Conditions: Finger Proximal Interphalangeal Joint Contracture

Treatments: Other: conventional stretching program; Other: shape memory alloy-based orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06716086

A-ER-113-251

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

SMA group

Experimental group

Description:

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.

Treatment:

Other: shape memory alloy-based orthosis

Stretching group

Active Comparator group

Description:

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.

Treatment:

Other: conventional stretching program