search
Back to results

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

Primary Purpose

Distal Radius Fracture

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 1 Elbow Flexed at 90 Degrees
Group 2 Elbow Fully Flexed
Sponsored by
Indiana Hand to Shoulder Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Distal Radius Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Indiana Hand to Shoulder Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Group 1: Elbow Flexed at 90 Degrees

Group 2: Elbow Fully Flexed

Arm Description

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

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

Outcomes

Primary Outcome Measures

Range of Motion
forearm supination and pronation and wrist ROm

Secondary Outcome Measures

Upper Limb Functional Index (ULFI)
PROM functional questionnaire
QuickDisability of the Arm Shoulder Hand (DASH)
PROM - functional questionnaire

Full Information

First Posted
April 18, 2023
Last Updated
May 8, 2023
Sponsor
Indiana Hand to Shoulder Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05850325
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana Hand to Shoulder Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Elbow Flexed at 90 Degrees
Arm Type
Other
Arm Description
subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion.
Arm Title
Group 2: Elbow Fully Flexed
Arm Type
Experimental
Arm Description
subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation.
Intervention Type
Other
Intervention Name(s)
Group 1 Elbow Flexed at 90 Degrees
Other Intervention Name(s)
Elbow Flexed to 90 Degrees
Intervention Description
subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion.
Intervention Type
Other
Intervention Name(s)
Group 2 Elbow Fully Flexed
Other Intervention Name(s)
Elbow Fully Flexed
Intervention Description
subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation.
Primary Outcome Measure Information:
Title
Range of Motion
Description
forearm supination and pronation and wrist ROm
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Upper Limb Functional Index (ULFI)
Description
PROM functional questionnaire
Time Frame
6 Months
Title
QuickDisability of the Arm Shoulder Hand (DASH)
Description
PROM - functional questionnaire
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Indiana Hand to Shoulder Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs