Healthy
Conditions
Brief 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.
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.
Interventions
DEVICEHely & Weber MTC Fracture Brace
Prefabricated muenster orthosis
DEVICEThermoplastic orthosis
Muenster orthosis fabricated out of thermoplastics and secured with Velcro
DEVICEDelta cast orthosis
Muenster orthosis fabricated out of Delta Cast and secured with Velcro
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Orthotics and Prosthetics User's Survey (OPUS ) | 1 day | 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- 1. . My orthosis fits well. 2. . The weight of my orthosis is manageable. 3. . It is easy to put on my orthosis. 4. . My orthosis is pain free to wear. 5. . 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Healthy Individuals | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 30 Participants | — |
| Age, Continuous | 36.9 years STANDARD_DEVIATION 12.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 Participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thermoplastic Results | Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC | 88.4 degrees | Standard Deviation 35.8 |
| Delta-Cast Results | Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC | 49.1 degrees | Standard Deviation 24.2 |
| Hely and Weber Fracture Brace MTC | Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC | 67.2 degrees | Standard Deviation 34.5 |
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- 1. . My orthosis fits well. 2. . The weight of my orthosis is manageable. 3. . It is easy to put on my orthosis. 4. . My orthosis is pain free to wear. 5. . 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.
Time frame: 1 day
Population: Participants were excluded from overall analysis if they answered don't know or not applicable for certain questions in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Thermoplastic Results | Orthotics and Prosthetics User's Survey (OPUS ) | My orthosis is pain free to wear | 4.2 Likert scale unit | Standard Deviation 0.9 |
| Thermoplastic Results | Orthotics and Prosthetics User's Survey (OPUS ) | Easy to put on orthosis | 3.5 Likert scale unit | Standard Deviation 1.2 |
| Thermoplastic Results | Orthotics and Prosthetics User's Survey (OPUS ) | My orthosis fits well | 4.2 Likert scale unit | Standard Deviation 0.9 |
| Thermoplastic Results | Orthotics and Prosthetics User's Survey (OPUS ) | The weight is manageable | 4.1 Likert scale unit | Standard Deviation 0.9 |
| Thermoplastic Results | Orthotics and Prosthetics User's Survey (OPUS ) | My orthosis looks good | 3.5 Likert scale unit | Standard Deviation 1.2 |
| Delta-Cast Results | Orthotics and Prosthetics User's Survey (OPUS ) | Easy to put on orthosis | 4.2 Likert scale unit | Standard Deviation 0.8 |
| Delta-Cast Results | Orthotics and Prosthetics User's Survey (OPUS ) | My orthosis fits well | 4.0 Likert scale unit | Standard Deviation 0.7 |
| Delta-Cast Results | Orthotics and Prosthetics User's Survey (OPUS ) | The weight is manageable | 4.3 Likert scale unit | Standard Deviation 0.7 |
| Delta-Cast Results | Orthotics and Prosthetics User's Survey (OPUS ) | My orthosis is pain free to wear | 4.0 Likert scale unit | Standard Deviation 0.9 |
| Delta-Cast Results | Orthotics and Prosthetics User's Survey (OPUS ) | My orthosis looks good | 4.2 Likert scale unit | Standard Deviation 0.8 |
| Hely and Weber Fracture Brace MTC | Orthotics and Prosthetics User's Survey (OPUS ) | My orthosis looks good | 3.4 Likert scale unit | Standard Deviation 1.2 |
| Hely and Weber Fracture Brace MTC | Orthotics and Prosthetics User's Survey (OPUS ) | My orthosis is pain free to wear | 4.5 Likert scale unit | Standard Deviation 0.9 |
| Hely and Weber Fracture Brace MTC | Orthotics and Prosthetics User's Survey (OPUS ) | My orthosis fits well | 4.7 Likert scale unit | Standard Deviation 0.5 |
| Hely and Weber Fracture Brace MTC | Orthotics and Prosthetics User's Survey (OPUS ) | Easy to put on orthosis | 3.8 Likert scale unit | Standard Deviation 1.2 |
| Hely and Weber Fracture Brace MTC | Orthotics and Prosthetics User's Survey (OPUS ) | The weight is manageable | 4.4 Likert scale unit | Standard Deviation 0.8 |