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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hely & Weber MTC Fracture Brace | Device | Prefabricated muenster orthosis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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-
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stepanie Kannas, CHT, OT, OTD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hely & Weber MTC Fracture Brace, Thermoplastic Orthosis and Delta-Cast Orthosis | Each participant received a sequence of three different orthotic interventions and served as his/her own match control to assess forearm range of motion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Individuals | Subject will be measured for forearm rotation while wearing the custom orthoses Hely & Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis. Hely & Weber MTC Fracture Brace: Prefabricated muenster orthosis Thermoplastic orthosis: Muenster orthosis fabricated out of thermoplastics and secured with Velcro Delta cast orthosis: Muenster orthosis fabricated out of Delta Cast and secured with Velcro |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | degrees | 1 day |
|
1 day
The nature of the study was completing normal standard of care for orthotic positioning. All safety practices were in place that are followed for standard clinic operations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hely & Weber MTC Fracture Brace | Participants served as their own matched controls for each of the three orthoses. |
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All measurements were performed on healthy individuals versus an injured arm. Since participants did not have symptoms, it made donning and doffing the orthoses easier. During testing, participants were asked to pronate and supinate until they felt resistance using sensory feedback as the stop point. This limitation allowed for the wide variant in allowable motion of each orthosis, as each participant's perception could be different when it comes to feeling resistance in an orthosis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Kannas, OTR/L, OTD, CHT | Mayo Clinic | 507-284-8841 | kannas.stephanie@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2019 | Oct 16, 2019 | Prot_SAP_001.pdf |
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| Thermoplastic orthosis |
| Device |
Muenster orthosis fabricated out of thermoplastics and secured with Velcro |
|
| Delta cast orthosis | Device | Muenster orthosis fabricated out of Delta Cast and secured with Velcro |
|
| 1 day |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 |
| Hely and Weber Fracture Brace MTC |
The 30 healthy participants trialing the Hely and Weber Fracture Brace MTC. Results reported in total arc of motion. |
|
|
| Secondary | 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-
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. | Participants were excluded from overall analysis if they answered don't know or not applicable for certain questions in the study. | Posted | Mean | Standard Deviation | Likert scale unit | 1 day |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Thermoplastic Orthosis | Participants served as their own matched controls for each of the three orthoses. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Delta-Cast Orthosis | Participants served as their own matched controls for each of the three orthoses. | 0 | 30 | 0 | 30 | 0 | 30 |
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| The weight is manageable |
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| Easy to put on orthosis |
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| My orthosis is pain free to wear |
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| My orthosis looks good |
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