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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05850325
• Other study ID #: DR VP ROM
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: April 2024

Study information

• Verified date: April 2023
• Source: Indiana Hand to Shoulder Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 42
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Indiana Hand to Shoulder Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana Hand to Shoulder Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion	forearm supination and pronation and wrist ROm	6 Months
Secondary	Upper Limb Functional Index (ULFI)	PROM functional questionnaire	6 Months
Secondary	QuickDisability of the Arm Shoulder Hand (DASH)	PROM - functional questionnaire	6 Months