A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Finger Proximal Interphalangeal Joint Contracture
- Sponsor
- National Cheng-Kung University Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Range Of Motion
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Range Of Motion
Time Frame: Baseline, 4 weeks after baseline, and 8 weeks after baseline
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.
Secondary Outcomes
- 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)