NCT05850325

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Indiana Hand to Shoulder Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Distal Radius Fracture

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2022-12-16
• Primary completion: 2023-12-01
• Completion: 2024-04-01
• First posted: 2023-05-09
• Last updated: 2023-05-09

Locations

1 site across 1 country: United States