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

NCT06716086 | Completed

• 1 other identifier: A-ER-113-251
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

shape memory alloy; finger stiffness; joint contracture; joint range of motion; hand injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Minnesota Manual Dexterity Test

  Baseline, 4 weeks after baseline, and 8 weeks after baseline

• Purdue Pegboard Test

  Baseline, 4 weeks after baseline, and 8 weeks after baseline

• Motion Capture and Analysis System

  Baseline, 4 weeks after baseline, and 8 weeks after baseline

• The Disability of the Arm, Shoulder and Hand Questionnaire, Taiwan version

  Baseline, 4 weeks after baseline, and 8 weeks after baseline

• System Usability Scale

  8 weeks after baseline

Study Arms (2)

SMA group

EXPERIMENTAL

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

Stretching group

ACTIVE COMPARATOR

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

Interventions

conventional stretching program OTHER

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.

Stretching group

shape memory alloy-based orthosis OTHER

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.

SMA group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Taiwan, 704, Taiwan

Location

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: March 12, 2025
• Primary Completion: March 30, 2026
• Study Completion: May 25, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)