Novel Exercises to Facilitate Recovery of Supination and Pronation for Distal Radius Fractures Managed With a Volar Plate

NCT05850325 | Unknown

• 1 other identifier: DR VP ROM
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the influence of elbow position on achieving forearm supination and pronation and wrist ROM postoperatively. It is anticipated the results will show recovery of functional motion in a shorter period of time (27 days average). As for the secondary objective of the study, it is anticipated there will be limited pain and cost-containment. These data elements will serve as secondary factors to evaluate.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• Range of Motion

  forearm supination and pronation and wrist ROm

  6 Months

Secondary Outcomes (2)

• Upper Limb Functional Index (ULFI)

  6 Months

• QuickDisability of the Arm Shoulder Hand (DASH)

  6 Months

Study Arms (2)

Group 1: Elbow Flexed at 90 Degrees

OTHER

subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion.

Other: Group 1 Elbow Flexed at 90 Degrees

Group 2: Elbow Fully Flexed

EXPERIMENTAL

subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation.

Other: Group 2 Elbow Fully Flexed

Interventions

Group 1 Elbow Flexed at 90 Degrees OTHER

subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion.

Also known as: Elbow Flexed to 90 Degrees

Group 1: Elbow Flexed at 90 Degrees

Group 2 Elbow Fully Flexed OTHER

subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation.

Also known as: Elbow Fully Flexed

Group 2: Elbow Fully Flexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18 years of age and older
• Subjects with distal radius fractures with a volar plate
• Subjects attending therapy at the Indiana Hand to Shoulder Center or affiliated satellites.
• Subjects that attend the initial therapy visit between 5 and 10 days postoperative and begin the home therapy program (patient handout)

You may not qualify if:

• Subjects under the age of 18
• Additional surgical procedures or other factors preventing early active ROM of the forearm and/or wrist within the initial 10 days following surgery
• Pre-existing medical conditions or injuries with resultant limitation in elbow, forearm or wrist ROM, patient-reported limited function, or limited ability to comply with home program (cognitive skills).
• While undergoing therapy the initial 6 weeks, subjects provided with custom-fabricated or pre-fabricated devices, orthoses, or braces for the specific purpose of passively improving ROM of the elbow, forearm or wrist during the initial 6 weeks of therapy.

Sponsors & Collaborators

• Indiana Hand to Shoulder Center: lead

Study Sites (1)

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 9, 2023
• Study Start: December 16, 2022
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)