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

Sponsor
Indiana Hand to Shoulder Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05850325
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
15.5
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Group 1 Elbow Flexed at 90 Degrees
  • Other: Group 2 Elbow Fully Flexed
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Novel Exercises to Facilitate Recovery of Supination and Pronation for Distal Radius Fractures Managed With a Volar Plate
Actual Study Start Date :
Dec 16, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Range of Motion [6 Months]

      forearm supination and pronation and wrist ROm

    Secondary Outcome Measures

    1. Upper Limb Functional Index (ULFI) [6 Months]

      PROM functional questionnaire

    2. QuickDisability of the Arm Shoulder Hand (DASH) [6 Months]

      PROM - functional questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana Hand to Shoulder Center Indianapolis Indiana United States 46260

    Sponsors and Collaborators

    • Indiana Hand to Shoulder Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Indiana Hand to Shoulder Center
    ClinicalTrials.gov Identifier:
    NCT05850325
    Other Study ID Numbers:
    • DR VP ROM
    First Posted:
    May 9, 2023
    Last Update Posted:
    May 9, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fractures, Bone
    Radius Fractures

    Study Results

    No Results Posted as of May 9, 2023