HealthyNCT04130425
A Comparison Study of Three Standard Elbow Wrist Hand Orthoses to Limit Forearm Rotation
A study testing Hely & Weber MTC Fracture Brace, Thermoplastic orthosis and Delta cast orthosis in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
The Researchers are trying to assess which splint limits forearm rotation the best. These splints are commonly used in hand therapy to limit forearm rotation. This data will help hand surgery and hand therapy provide better outcomes. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hely & Weber MTC Fracture Brace, Thermoplastic orthosis and Delta cast orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No prior wrist or elbow injuries on the dominant side of his/her body
- Ability to complete study in one sitting of 90-120 minutes
- Between the ages of 18 years and 100 years
- Ability to follow directions and speak and read English
Who cannot join
- Prior wrist or elbow injuries on the dominant side of his/her body
- Subjects with known rheumatoid arthritis deformities of the wrist or any prior wrist surgeries are excluded
Trial locations and contacts
1 site in 1 country.
About this study
The Researchers are trying to assess which splint limits forearm rotation the best. These splints are commonly used in hand therapy to limit forearm rotation. This data will help hand surgery and hand therapy provide better outcomes.
Read the detailed description
Common upper extremity injuries often need to heal with no wrist and forearm range of motion. Forearm range of motion includes supination and pronation. Injuries that necessitate limiting forearm range of motion include fracture patterns involving the distal radioulnar joint (DRUJ), proximal radioulnar joint (PRUJ), triangular fibrocartilage complex (TFCC), both bone forearm fractures, ulnar shortening procedures, radial and ulnar osteotomies, DRUJ instability. Long arm orthoses, sugar tong orthoses and muenster style orthoses can all limit forearm rotation.
Past research has indicated common methods of immobilization to include the following: sugar tongs cast/orthosis, muenster cast/orthosis, long arm cast/orthosis/or short arm cast/orthosis, and an antirotation orthosis.
Currently, there are no research studies that compare the amount of forearm rotation in a traditional thermoplastic orthoses to newer materials such as a Delta Cast orthosis, or prefabricated muenster orthoses such as the Hely and Weber MTC Fracture Brace. The purpose of this study is to assess which orthosis-a traditional thermoplastic ulnar based muenster, a delta cast style muenster and the Hely and Weber MTC Fracture Brace-allows for the least amount of supination and pronation in a healthy population in the dominant extremity.
The researchers will assess the 3 different orthoses using a standard measuring device for pronation and supination. The participants will also be asked questions regarding comfort, fit, and style of each orthosis. 30 Participants data will be collected during the study.
- Conditions
- Healthy
- Being tested
- Hely & Weber MTC Fracture Brace, Thermoplastic orthosis, Delta cast orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hely & Weber MTC Fracture BraceDevice
Prefabricated muenster orthosis
Thermoplastic orthosisDevice
Muenster orthosis fabricated out of thermoplastics and secured with Velcro
Delta cast orthosisDevice
Muenster orthosis fabricated out of Delta Cast and secured with Velcro
| Study group | Role | What they receive |
|---|---|---|
| Healthy Individuals | Experimental | Subject will be measured for forearm rotation while wearing the custom orthoses Hely \& Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis. Receives: Device: Hely & Weber MTC Fracture Brace; Device: Thermoplastic orthosis; Device: Delta cast orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC
Degree of forarm rotation (supination/pronation) measured by an electronic goniometer device reported unit of measurement in degrees while wearing each of the orthoses.
Measured: 1 day
Secondary outcomes (1)
Orthotics and Prosthetics User's Survey (OPUS )
The OPUS is a well validated, self-report questionnaire which consists of five modules; specifically, five questions from the OPUS: Satisfaction with Device and Services Module were used. These five questions were scored on a 5-point Likert scale from strongly agree to strongly disagree. A sixth option of "don't know" or "not applicable" was also available. Strongly agree = 5, Agree = 4, Neutral =3, Disagree =2, Strongly Disagree =1. If the participant chose don't know or not applicable that question was excluded for that participant.
The five questions included-
- . My orthosis fits well.
- . The weight of my orthosis is manageable.
- . It is easy to put on my orthosis.
- . My orthosis is pain free to wear.
- . My orthosis looks good.
The remaining 16 questions from the module were excluded, as they did not pertain to healthy volunteers wearing the orthosis only during his/her research participation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start6 Dec 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie N. Kannas, Mayo Clinic
- Investigators
- Stepanie Kannas, CHT, OT, OTD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130425
- Sponsor's protocol ID
- 18-008562
- Status last verified
- Nov 2020
- First submitted
- 13 Oct 2019
- Last updated
- 1 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of Three Standard Elbow Wrist Hand Orthoses to Limit Forearm Rotation
- ClinicalTrials.gov ID
- NCT04130425
- Acronym / sponsor ID
- 18-008562
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Posted 1 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Researchers are trying to assess which splint limits forearm rotation the best. These splints are commonly used in hand therapy to limit forearm rotation. This data will help hand surgery and hand therapy provide better outcomes.
Detailed description
Common upper extremity injuries often need to heal with no wrist and forearm range of motion. Forearm range of motion includes supination and pronation. Injuries that necessitate limiting forearm range of motion include fracture patterns involving the distal radioulnar joint (DRUJ), proximal radioulnar joint (PRUJ), triangular fibrocartilage complex (TFCC), both bone forearm fractures, ulnar shortening procedures, radial and ulnar osteotomies, DRUJ instability. Long arm orthoses, sugar tong orthoses and muenster style orthoses can all limit forearm rotation.
Past research has indicated common methods of immobilization to include the following: sugar tongs cast/orthosis, muenster cast/orthosis, long arm cast/orthosis/or short arm cast/orthosis, and an antirotation orthosis.
Currently, there are no research studies that compare the amount of forearm rotation in a traditional thermoplastic orthoses to newer materials such as a Delta Cast orthosis, or prefabricated muenster orthoses such as the Hely and Weber MTC Fracture Brace. The purpose of this study is to assess which orthosis-a traditional thermoplastic ulnar based muenster, a delta cast style muenster and the Hely and Weber MTC Fracture Brace-allows for the least amount of supination and pronation in a healthy population in the dominant extremity.
The researchers will assess the 3 different orthoses using a standard measuring device for pronation and supination. The participants will also be asked questions regarding comfort, fit, and style of each orthosis. 30 Participants data will be collected during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Individuals | Experimental | Device: Hely & Weber MTC Fracture Brace, Device: Thermoplastic orthosis, Device: Delta cast orthosisSubject will be measured for forearm rotation while wearing the custom orthoses Hely \& Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No prior wrist or elbow injuries on the dominant side of his/her body
- Ability to complete study in one sitting of 90-120 minutes
- Between the ages of 18 years and 100 years
- Ability to follow directions and speak and read English
Key exclusion criteria (2 listed)
- Prior wrist or elbow injuries on the dominant side of his/her body
- Subjects with known rheumatoid arthritis deformities of the wrist or any prior wrist surgeries are excluded
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 |
|---|---|---|
| Hely & Weber MTC Fracture BracePrefabricated muenster orthosis | Device | Healthy Individuals |
| Thermoplastic orthosisMuenster orthosis fabricated out of thermoplastics and secured with Velcro | Device | Healthy Individuals |
| Delta cast orthosisMuenster orthosis fabricated out of Delta Cast and secured with Velcro | Device | Healthy Individuals |
Primary outcome
Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC
Time frame: 1 day
Degree of forarm rotation (supination/pronation) measured by an electronic goniometer device reported unit of measurement in degrees while wearing each of the orthoses.
1 secondary outcome
Orthotics and Prosthetics User's Survey (OPUS )
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Stepanie Kannas, CHT, OT, OTD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hely & Weber MTC Fracture Brace, Thermoplastic orthosis and Delta cast orthosis in people with Healthy, run by Mayo Clinic 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 2 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 1 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC (time frame: 1 day). 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 1 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.