A Comparison Study of Three Standard Elbow Wrist Hand Orthoses to Limit Forearm Rotation

NCT04130425 | Completed Results FDA Device

• 1 other identifier: 18-008562
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Orthotics and Prosthetics User's Survey (OPUS )

  1 day

Study Arms (1)

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.

Device: Hely & Weber MTC Fracture Brace; Device: Thermoplastic orthosis; Device: Delta cast orthosis

Interventions

Hely & Weber MTC Fracture Brace DEVICE

Prefabricated muenster orthosis

Healthy Individuals

Thermoplastic orthosis DEVICE

Muenster orthosis fabricated out of thermoplastics and secured with Velcro

Healthy Individuals

Delta cast orthosis DEVICE

Muenster orthosis fabricated out of Delta Cast and secured with Velcro

Healthy Individuals

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Limitations and Caveats

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.

Results Point of Contact

• Title: Stephanie Kannas, OTR/L, OTD, CHT
• Organization: Mayo Clinic

kannas.stephanie@mayo.edu

507-284-8841

Study Officials

• Stepanie Kannas, CHT, OT, OTD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 17, 2019
• Study Start: December 6, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: December 1, 2020
• Results First Posted: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)