Finger Proximal Interphalangeal Joint ContractureNCT06716086
A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness
A study testing shape memory alloy-based orthosis and conventional stretching program in people with Finger Proximal Interphalangeal Joint Contracture, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Finger Proximal Interphalangeal Joint Contracture
- What is being tested?
- shape memory alloy-based orthosis and conventional stretching program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Mar 2025to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- shape memory alloy-based orthosis, conventional stretching program
- Keywords
- shape memory alloy, finger stiffness, joint contracture, joint range of motion, hand injury
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shape memory alloy-based orthosisOther
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.
conventional stretching programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: conventional stretching program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks after baseline, and 8 weeks after baseline
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start12 Mar 2025
- Primary completion30 Mar 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Finger Proximal Interphalangeal Joint ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716086
- Sponsor's protocol ID
- A-ER-113-251
- Status last verified
- May 2026
- First submitted
- 29 Nov 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness
- ClinicalTrials.gov ID
- NCT06716086
- Acronym / sponsor ID
- A-ER-113-251
- Keywords
- shape memory alloy, finger stiffness, joint contracture, joint range of motion, hand injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMA group | Experimental | Other: shape memory alloy-based orthosisParticipants 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. |
| Stretching group | Active comparator | Other: conventional stretching programParticipants 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shape memory alloy-based orthosisThe 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 | SMA group |
| conventional stretching programThe 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. | Other | Stretching group |
Primary outcome
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.
5 secondary outcomes
Minnesota Manual Dexterity Test
Time frame: Baseline, 4 weeks after baseline, and 8 weeks after baseline
Purdue Pegboard Test
Time frame: Baseline, 4 weeks after baseline, and 8 weeks after baseline
Motion Capture and Analysis System
Time frame: Baseline, 4 weeks after baseline, and 8 weeks after baseline
The Disability of the Arm, Shoulder and Hand Questionnaire, Taiwan version
Time frame: Baseline, 4 weeks after baseline, and 8 weeks after baseline
System Usability Scale
Time frame: 8 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shape memory alloy-based orthosis and conventional stretching program in people with Finger Proximal Interphalangeal Joint Contracture, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range Of Motion (time frame: Baseline, 4 weeks after baseline, and 8 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.