- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05351060
Novel Splinting Technique Using 3D Models
Implementing a Novel Splinting Technique Using 3D Models for Patients With Scleroderma and Arthritis: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christine Mulligan, OTD
- Phone Number: 518-244-2266
- Email: mullic@sage.edu
Study Contact Backup
- Name: Debra Collette, OTD
- Phone Number: 518-244-4591
- Email: colled@sage.edu
Study Locations
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New York
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Troy, New York, United States, 12180
- Russell Sage College
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Contact:
- Christine Mulligan, Doctorate
- Phone Number: 518-244-4591
- Email: mullic@sage.edu
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Contact:
- Debra Collette, Doctorate
- Phone Number: 518-244-4591
- Email: colled@sage.edu
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Sub-Investigator:
- Giovanna Fichera, B.S
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Sub-Investigator:
- Celeste Freeman, B.S
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3D model splinting intervention group
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.
|
Participants will wear a customized splint on their affected hand(s)during the hours of sleep for the duration of the study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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).
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During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)
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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.
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Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
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During the initial visit (two weeks before the intervention begins) and again during the second clinical visit (the day before the intervention begins)
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Change of reported comfort level (in hand) measured through a survey
Time Frame: Daily throughout the six week intervention period
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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.
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Daily throughout the six week intervention period
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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)
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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.
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During the initial visit (two weeks before the intervention begins) and during the second clinical visit (the day before the intervention begins)
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Change in hours of sleep measured through a survey
Time Frame: Daily throughout the six week intervention period
|
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.
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Daily throughout the six week intervention period
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Disability of the Arm, Shoulder, and Hand Questionnaire
Time Frame: One time before the intervention begins (During the initial visit)
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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.
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One time before the intervention begins (During the initial visit)
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Disability of the Arm, Shoulder, and Hand Questionnaire
Time Frame: One time within a week of completing the six week intervention
|
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.
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One time within a week of completing the six week intervention
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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
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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.
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Photographs of the hand will be taken one day before the six week intervention begins
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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.
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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.
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Every other week throughout the intervention period, a total of three times during the intervention which is six weeks long.
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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)
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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:
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Half way through the six week intervention period the participants will be interviewed (at week three)
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Patient satisfaction with splinting process - Individual Interview
Time Frame: Within a week of completing the six week intervention, the participants will be interviewed
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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? |
Within a week of completing the six week intervention, the participants will be interviewed
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-1019-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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