Trial Outcomes & Findings for A Comparison Study of Three Standard Elbow Wrist Hand Orthoses to Limit Forearm Rotation (NCT NCT04130425)
NCT ID: NCT04130425
Last Updated: 2020-12-01
Results Overview
Degree of forarm rotation (supination/pronation) measured by an electronic goniometer device reported unit of measurement in degrees while wearing each of the orthoses.
COMPLETED
NA
30 participants
1 day
2020-12-01
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Individuals
n=30 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 12.5 • n=30 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 1 dayDegree of forarm rotation (supination/pronation) measured by an electronic goniometer device reported unit of measurement in degrees while wearing each of the orthoses.
Outcome measures
| Measure |
Thermoplastic Results
n=30 Participants
The 30 healthy participants trialing the thermoplastic orthosis. Total arc of motion reported.
|
Delta-Cast Results
n=30 Participants
The 30 healthy participants trialing the Delta-Cast orthosis. Results are total arc of motion.
|
Hely and Weber Fracture Brace MTC
n=30 Participants
The 30 healthy participants trialing the Hely and Weber Fracture Brace MTC. Results reported in total arc of motion.
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|---|---|---|---|
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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
|
49.1 degrees
Standard Deviation 24.2
|
67.2 degrees
Standard Deviation 34.5
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Participants were excluded from overall analysis if they answered don't know or not applicable for certain questions in the study.
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.
Outcome measures
| Measure |
Thermoplastic Results
n=30 Participants
The 30 healthy participants trialing the thermoplastic orthosis. Total arc of motion reported.
|
Delta-Cast Results
n=30 Participants
The 30 healthy participants trialing the Delta-Cast orthosis. Results are total arc of motion.
|
Hely and Weber Fracture Brace MTC
n=30 Participants
The 30 healthy participants trialing the Hely and Weber Fracture Brace MTC. Results reported in total arc of motion.
|
|---|---|---|---|
|
Orthotics and Prosthetics User's Survey (OPUS )
My orthosis fits well
|
4.2 Likert scale unit
Standard Deviation 0.9
|
4.0 Likert scale unit
Standard Deviation 0.7
|
4.7 Likert scale unit
Standard Deviation 0.5
|
|
Orthotics and Prosthetics User's Survey (OPUS )
The weight is manageable
|
4.1 Likert scale unit
Standard Deviation 0.9
|
4.3 Likert scale unit
Standard Deviation 0.7
|
4.4 Likert scale unit
Standard Deviation 0.8
|
|
Orthotics and Prosthetics User's Survey (OPUS )
Easy to put on orthosis
|
3.5 Likert scale unit
Standard Deviation 1.2
|
4.2 Likert scale unit
Standard Deviation 0.8
|
3.8 Likert scale unit
Standard Deviation 1.2
|
|
Orthotics and Prosthetics User's Survey (OPUS )
My orthosis is pain free to wear
|
4.2 Likert scale unit
Standard Deviation 0.9
|
4.0 Likert scale unit
Standard Deviation 0.9
|
4.5 Likert scale unit
Standard Deviation 0.9
|
|
Orthotics and Prosthetics User's Survey (OPUS )
My orthosis looks good
|
3.5 Likert scale unit
Standard Deviation 1.2
|
4.2 Likert scale unit
Standard Deviation 0.8
|
3.4 Likert scale unit
Standard Deviation 1.2
|
Adverse Events
Hely & Weber MTC Fracture Brace
Thermoplastic Orthosis
Delta-Cast Orthosis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place