ArthritisNCT05351060
Novel Splinting Technique Using 3D Models
A study testing Custom Fabricated Splint in people with Arthritis and Osteoarthritis Hand, run by Giovanna Fichera at 1 site in United States.
Trial summary
The purpose of the study is to determine the feasibility of a non-contact custom splint fabrication method for patients with chronic diseases suffering from hypersensitive skin or compromised skin integrity. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arthritis, Osteoarthritis Hand, Scleroderma, Systemic
- What is being tested?
- Custom Fabricated Splint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 19 Aug 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of either scleroderma, osteoarthritis, or rheumatoid arthritis
- Must have the potential to benefit from wearing a resting hand splint as determined by a certified hand therapist
- Over 18 years of age
- Fluent in English
Who cannot join
- Patients exhibiting any open wounds on their hands or forearms
- Exhibiting impaired decision making and ability to understand splint care and wear instructions as determined by the ability to answer the questions the student researcher asks after the participant has reviewed the splint education handout
- Under 18 years of age
- Unable to secure reliable transport for the duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Russell Sage College
Troy, New York, 12180
Christine Mulligan, Doctorate, 518-244-4591, mullic@sage.edu
Debra Collette, Doctorate, 518-244-4591, colled@sage.edu
About this study
Official title: Implementing a Novel Splinting Technique Using 3D Models for Patients With Scleroderma and Arthritis: A Pilot Study
The purpose of the study is to determine the feasibility of a non-contact custom splint fabrication method for patients with chronic diseases suffering from hypersensitive skin or compromised skin integrity. Custom splinting by occupational therapists involves molding low-temperature thermoplastic material directly on patients' skin; however, skin sensitivity is a contraindication for splint fabrication. The study aims to recruit 10 male or female patients with either a diagnosis of scleroderma (SSc) or arthritis. A scan of the patient's hand and a 3D printer will be used to create a precise model of a patient's hand on which a custom splint will be fabricated. By taking this approach, traditional splinting is substituted by avoiding direct contact with the material on the surface of the patient's upper extremity. This technique creates therapeutic opportunities for underserved patients by expanding splinting options for patients with scleroderma and arthritis, and addressing the challenges associated with managing chronic diseases.
Read the detailed description
Arthritis is an inflammatory disease that occurs in the joints of the body. Scleroderma is a disease of the autoimmune system in which the body produces excess collagen in the skin and organs. Depending upon a patient's needs, occupational therapists (OTs) make custom hand splints to support individual goals and promote independence. Conventional splinting methods involve molding low-temperature thermoplastic material directly on a patients' skin; however, many chronic diseases including arthritis and scleroderma carry a predisposition for skin sensitivity or compromised skin integrity, leaving these populations with no alternative. The study will recruit 10 male or female patients with either a diagnosis of arthritis or scleroderma for a 14-week study. Researchers will use a scanner and 3D printer to create a model of a patient's hand prior to splinting, which will allow therapists to custom-fit the 105-degree splinting material on the model. Traditional splinting is substituted by avoiding fabricating the splint directly on the patient's hand and providing the opportunity for patients with hypersensitive skin to benefit from a custom-made splint. Implementing this technique creates opportunities by expanding splinting options for patients with chronic diseases. The goals of this study are to evaluate effectiveness, support positive engagement in daily activities, improve patient outcomes, and promote best practice. The research will also establish a foundation for future studies with custom splinting using 3D printed material.
- Conditions
- Arthritis, Osteoarthritis Hand, Scleroderma, Systemic, Scleroderma, Diffuse, Rheumatoid Arthritis
- Being tested
- Custom Fabricated Splint
- Keywords
- Splints, Occupational Therapy, Hand, Printing, Three-Dimensional, Contracture, Rheumatology, Ulcer, Orthotic Devices, Range of Motion, Articular
- Medical subject headings
- Arthritis, Scleroderma, Systemic, Scleroderma, Diffuse, Arthritis, Rheumatoid, Contracture, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom Fabricated SplintOther
Also called Orthotic
Participants will wear a customized splint on their affected hand(s)during the hours of sleep for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| 3D model splinting intervention group | Experimental | The researcher will scan the participant's forearm, wrist, and hand with an iPhone camera through the Comb O\&P Scan App. Scans will be completed individually to maintain privacy. The entire Comb O\&P platform is HIPAA compliant. The data is de-identified encrypted when it moves from the iPhone app to the computer through the cloud. Precision Valve Automation (PVA) will use the de-identified scans to print the 3D models which are a precise replica of the participant's hand. Once the researcher obtains the 3D models, resting hand splints will be fabricated on the 3D models to provide custom-made hand splint(s) to each participant. The participants will receive the splint(s) to wear during the hours of sleep for six weeks. Receives: Other: Custom Fabricated Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in range of motion of the hand (measured with a goniometer)
The active range of motion of the participant's affected forearm, wrist, and fingers will be assessed with a goniometer. A change in range of motion across two weeks is being assessed (before the intervention begins).
Measured: During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)
Change in range of motion of the hand (measured with a goniometer)
The active range of motion of the participant's affected forearm, wrist, and fingers will be assessed with a goniometer. A change in range of motion across the six week intervention period will be assessed.
Measured: Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
Secondary outcomes (10)
Change of reported comfort level (in hand) measured through a survey
Patients will document their perceived comfort level in their affected hand in a questionnaire twice, across two weeks, before the study intervention begins. The scale is 0-10. 0 being least uncomfortable to 10 being very comfortable. The change in comfort across two weeks is being assessed before the intervention begins.
Measured: During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)
Change of reported comfort level (in hand) measured through a survey
Patients will report their perceived comfort level in their hand each morning after wearing the splint in an online or hard copy questionnaire. The scale is 0-10. 0 being least uncomfortable to 10 being very comfortable. The change in comfort in the hand across the six week intervention period is being assessed.
Measured: Daily throughout the six week intervention period
Change in hours of sleep measured through a survey
Participants will log their hours of sleep and hours they wear their splint each night to determine if they are able to sleep longer when wearing the splint compared to before they wore the splint. This data will be tracked to ensure the intervention is not decreasing hours of sleep significantly. The change in hours of sleep across two weeks (before the intervention begins) will be assessed.
Measured: During the initial visit (two weeks before the intervention begins) and during the second clinical visit (the day before the intervention begins)
Change in hours of sleep measured through a survey
Participants will log their hours of sleep and hours they wear their splint each night to determine if they are able to sleep longer when wearing the splint compared to before they wore the splint. This data will be tracked to ensure the intervention is not decreasing hours of sleep significantly. The change in hours of sleep across the six-week intervention period will be assessed.
Measured: Daily throughout the six week intervention period
Disability of the Arm, Shoulder, and Hand Questionnaire
Self-administered outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. This will be used to assess the participant's ability to complete occupation based tasks with their affected hand.
Measured: One time before the intervention begins (During the initial visit)
Disability of the Arm, Shoulder, and Hand Questionnaire
Self-administered outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. This will be used to assess the participant's ability to complete occupation based tasks with their affected hand.
Measured: One time within a week of completing the six week intervention
Number of patients with intact skin integrity of the hands through photographs
Photographs of the wrist and hand will be taken to assess the skin integrity of the hand that is wearing the splint. Intact skin integrity is indicated by the absence of ulcers, sores, and redness.
Measured: Photographs of the hand will be taken one day before the six week intervention begins
Change in the number of patients with intact skin integrity of the hands through photographs
Photographs of the wrist and hand will be taken to assess the skin integrity of the hand that is wearing the splint. Intact skin integrity is indicated by the absence of ulcers, sores, and redness.
Measured: Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
Patient satisfaction with splinting process - Individual Interview
The participants will complete a brief 15 minute interview to assess their overall satisfaction with the novel splinting method and splinting intervention. The interview will occur via Zoom or phone call. The participant will answer the following questions:
- How do you feel the scanning process went?
- Were you uncomfortable at all throughout the scanning process? (ie. Did your arm feel discomfort at any point? If so on a scale from 0-10 what was the discomfort level?)
- How do you feel the splint intervention is going?
- Do you have any questions or concerns?
Measured: Half way through the six week intervention period the participants will be interviewed (at week three)
Patient satisfaction with splinting process - Individual Interview
The participants will complete a brief 15 minute interview to assess their overall satisfaction with the novel splinting method and splinting intervention. The interview will occur via Zoom or phone call. The participant will answer the following questions:
How do you feel the splint intervention went? 2. What would you have wished would have been different throughout this process? 3. Do you feel as though this process was beneficial for you?
Measured: Within a week of completing the six week intervention, the participants will be interviewed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start16 May 2022 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion19 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will include up to 10 patients with autoimmune diseases, including either scleroderma, rheumatoid arthritis, or osteoarthritis, which may include the elderly. The study will compare pre and post-evaluation measures for each individual participant through a multiple time series design.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giovanna Fichera
- Sponsor type
- University, hospital or other
- Collaborators
- Precision Valve Automation, St Peters Health Partners, Ann Steffens Scleroderma Foundation, Russell Sage College
- Responsible party
- Sponsor-investigator, Giovanna Fichera, Russell Sage College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351060
- Sponsor's protocol ID
- 21-1019-1
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2022
- Last updated
- 28 Apr 2022
- 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 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Novel Splinting Technique Using 3D Models for Patients With Scleroderma and Arthritis: A Pilot Study
- ClinicalTrials.gov ID
- NCT05351060
- Acronym / sponsor ID
- 21-1019-1
- Conditions
- Arthritis, Osteoarthritis Hand, Scleroderma, Systemic, Scleroderma, Diffuse, Rheumatoid Arthritis
- Keywords
- Splints, Occupational Therapy, Hand, Printing, Three-Dimensional, Contracture, Rheumatology, Ulcer, Orthotic Devices, Range of Motion, Articular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Giovanna FicheraUniversity, hospital or other
- Collaborators
- Precision Valve Automation, St Peters Health Partners, Ann Steffens Scleroderma Foundation, Russell Sage College
- Study start
- 16 May 2022 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 19 Aug 2022 (estimated)
- First posted
- 28 Apr 2022 (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 purpose of the study is to determine the feasibility of a non-contact custom splint fabrication method for patients with chronic diseases suffering from hypersensitive skin or compromised skin integrity. Custom splinting by occupational therapists involves molding low-temperature thermoplastic material directly on patients' skin; however, skin sensitivity is a contraindication for splint fabrication. The study aims to recruit 10 male or female patients with either a diagnosis of scleroderma (SSc) or arthritis. A scan of the patient's hand and a 3D printer will be used to create a precise model of a patient's hand on which a custom splint will be fabricated. By taking this approach, traditional splinting is substituted by avoiding direct contact with the material on the surface of the patient's upper extremity. This technique creates therapeutic opportunities for underserved patients by expanding splinting options for patients with scleroderma and arthritis, and addressing the challenges associated with managing chronic diseases.
Detailed description
Arthritis is an inflammatory disease that occurs in the joints of the body. Scleroderma is a disease of the autoimmune system in which the body produces excess collagen in the skin and organs. Depending upon a patient's needs, occupational therapists (OTs) make custom hand splints to support individual goals and promote independence. Conventional splinting methods involve molding low-temperature thermoplastic material directly on a patients' skin; however, many chronic diseases including arthritis and scleroderma carry a predisposition for skin sensitivity or compromised skin integrity, leaving these populations with no alternative. The study will recruit 10 male or female patients with either a diagnosis of arthritis or scleroderma for a 14-week study. Researchers will use a scanner and 3D printer to create a model of a patient's hand prior to splinting, which will allow therapists to custom-fit the 105-degree splinting material on the model. Traditional splinting is substituted by avoiding fabricating the splint directly on the patient's hand and providing the opportunity for patients with hypersensitive skin to benefit from a custom-made splint. Implementing this technique creates opportunities by expanding splinting options for patients with chronic diseases. The goals of this study are to evaluate effectiveness, support positive engagement in daily activities, improve patient outcomes, and promote best practice. The research will also establish a foundation for future studies with custom splinting using 3D printed material.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will include up to 10 patients with autoimmune diseases, including either scleroderma, rheumatoid arthritis, or osteoarthritis, which may include the elderly. The study will compare pre and post-evaluation measures for each individual participant through a multiple time series design.
| Arm | Type | Receives |
|---|---|---|
| 3D model splinting intervention group | Experimental | Other: Custom Fabricated SplintThe researcher will scan the participant's forearm, wrist, and hand with an iPhone camera through the Comb O\&P Scan App. Scans will be completed individually to maintain privacy. The entire Comb O\&P platform is HIPAA compliant. The data is de-identified encrypted when it moves from the iPhone app to the computer through the cloud. Precision Valve Automation (PVA) will use the de-identified scans to print the 3D models which are a precise replica of the participant's hand. Once the researcher obtains the 3D models, resting hand splints will be fabricated on the 3D models to provide custom-made hand splint(s) to each participant. The participants will receive the splint(s) to wear during the hours of sleep for six weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a diagnosis of either scleroderma, osteoarthritis, or rheumatoid arthritis
- Must have the potential to benefit from wearing a resting hand splint as determined by a certified hand therapist
- Over 18 years of age
- Fluent in English
Key exclusion criteria (4 listed)
- Patients exhibiting any open wounds on their hands or forearms
- Exhibiting impaired decision making and ability to understand splint care and wear instructions as determined by the ability to answer the questions the student researcher asks after the participant has reviewed the splint education handout
- Under 18 years of age
- Unable to secure reliable transport for the duration of the study
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 |
|---|---|---|
| Custom Fabricated SplintAlso: OrthoticParticipants will wear a customized splint on their affected hand(s)during the hours of sleep for the duration of the study. | Other | 3D model splinting intervention group |
Primary outcome
Change in range of motion of the hand (measured with a goniometer)
Time frame: During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)
The active range of motion of the participant's affected forearm, wrist, and fingers will be assessed with a goniometer. A change in range of motion across two weeks is being assessed (before the intervention begins).
Change in range of motion of the hand (measured with a goniometer)
Time frame: Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
The active range of motion of the participant's affected forearm, wrist, and fingers will be assessed with a goniometer. A change in range of motion across the six week intervention period will be assessed.
10 secondary outcomes
Change of reported comfort level (in hand) measured through a survey
Time frame: During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)
Change of reported comfort level (in hand) measured through a survey
Time frame: Daily throughout the six week intervention period
Change in hours of sleep measured through a survey
Time frame: During the initial visit (two weeks before the intervention begins) and during the second clinical visit (the day before the intervention begins)
Change in hours of sleep measured through a survey
Time frame: Daily throughout the six week intervention period
Disability of the Arm, Shoulder, and Hand Questionnaire
Time frame: One time before the intervention begins (During the initial visit)
Disability of the Arm, Shoulder, and Hand Questionnaire
Time frame: One time within a week of completing the six week intervention
Number of patients with intact skin integrity of the hands through photographs
Time frame: Photographs of the hand will be taken one day before the six week intervention begins
Change in the number of patients with intact skin integrity of the hands through photographs
Time frame: Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
Patient satisfaction with splinting process - Individual Interview
Time frame: Half way through the six week intervention period the participants will be interviewed (at week three)
Patient satisfaction with splinting process - Individual Interview
Time frame: Within a week of completing the six week intervention, the participants will be interviewed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom Fabricated Splint in people with Arthritis and Osteoarthritis Hand, run by Giovanna Fichera at 1 site in United States.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Mulligan, OTD (518-244-2266, mullic@sage.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in range of motion of the hand (measured with a goniometer) (time frame: During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)). The study lists 2 primary outcomes in all. 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 28 Apr 2022.