Clinical trial NCT05850325: Novel Exercises to Facilitate Recovery of Supination and Pronation for Distal Radius Fractures Managed With a Volar Plate
Official title: Novel Exercises to Facilitate Recovery of Supination and Pronation for Distal Radius Fractures Managed With a Volar Plate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Indiana Hand to Shoulder Center
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Range of Motion
timeFrame: 6 Months
Secondary outcomes:
measure: Upper Limb Functional Index (ULFI)
timeFrame: 6 Months
measure: QuickDisability of the Arm Shoulder Hand (DASH)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
Study officials:
References: