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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Other: Group 1 Elbow Flexed at 90 Degrees; Other: Group 2 Elbow Fully Flexed

Detailed Description

The current standard of care for forearm range of motion exercises is to position the elbow in 90 degrees of flexion at the side of the body for both supination and pronation.5,6 This study will compare standard of care forearm rotation exercises to exercising with the elbow in extension to facilitate pronation and exercising with the elbow in full flexion to facilitate supination in patients who have undergone surgery with a volar plate for distal radius fractures. We hypothesize that forearm motion will be achieved in a shorter number of days and with a greater arc of motion when the exercises are done in extremes of elbow flexion and extension.

This will be a prospective, unblinded, randomized study to evaluate forearm range of motion across two groups:

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

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

Randomization will occur post-operatively after the patient has signed consent to participate. Randomization will occur through a computerized random allocation and groups will be assigned by the Clinical Research Manager or designee.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Indiana Hand to Shoulder Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • 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)

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1: Elbow Flexed at 90 Degrees; 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; subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion.; Other Names: Elbow Flexed to 90 Degrees
Experimental: Group 2: Elbow Fully Flexed; 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; subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation.; Other Names: Elbow Fully Flexed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	forearm supination and pronation and wrist ROm	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Limb Functional Index (ULFI)	PROM functional questionnaire	6 Months
QuickDisability of the Arm Shoulder Hand (DASH)	PROM - functional questionnaire	6 Months

Collaborators and Investigators

• Sponsor: Indiana Hand to Shoulder Center

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: DR VP ROM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No