Digital Media Based Physical Therapy Post Distal Radius Fracture

Physical Therapy After Distal Radius Fracture; Traditional Versus Digital Media Based Therapy Protocol

This trial aims to develop and test the efficacy of a digital media based physical therapy protocol on patients after surgical fixation and non-operative treatment of distal radius fractures.It is hypothesized that there will not be a difference in outcomes for patients after surgical fixation of distal radius fractures with traditional physical therapy and digital media based therapy

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Other: Digital Media Based Physical Therapy; Other: Traditional Physical Therapy

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing operative treatment for distal radius fractures.

Exclusion Criteria:

• Poly-trauma patients with significant previous diagnosis of dementia, previous traumatic brain injury, or other reason for significant altered mental status that would interfere with their participation in therapist directed or digital based therapy will be excluded.
• Patients who present to Oregon Health & Science University for physical therapy who will be treated by a physician at another non Oregon Health & Science University facility will be excluded.
• Patients who are not proficient in the English language will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Media Therapy; The digital media based group will receive a modified post immobilization protocol. This will include giving the patients a Universal Serial Bus (USB) drive loaded with a 12 week physical therapy protocol presented in digital form with videos and graphical representations of exercises to be done. They will also have access to the videos and multimedia on the Oregon Health & Science University website.	Other: Digital Media Based Physical Therapy; This intervention is a modified post immobilization protocol. This will include giving the patients a USB drive loaded with a 12 week therapy protocol presented in digital form with videos and graphical representations of exercises to be done. They will also have access to the videos and multimedia on the Oregon Health & Science University website.
Active Comparator: Traditional Therapy; The traditional group will have clinic-based physical therapy protocol.	Other: Traditional Physical Therapy; This intervention is a 12 week therapist supervised clinic-based therapy protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)	Patient-Reported Outcome, Scale: 0 (no disability) - 100 (most severe disability)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)	Patient-Reported Outcome, Scale: 0 (no disability) - 100 (most severe disability)	6 weeks, 6 months
Visual Analog Pain Scale	Patient-Reported Outcome, Scale: 0 (no pain) - 10 (most severe pain)	6 weeks, 12 weeks, and 6 months
Veterans RAND 12-item Health Survey (VR-12)	Patient-Reported Outcome	6 weeks, 12 weeks, and 6 months
Wrist Range of Motion	Wrist flexion, extension, pronation, supination, ulnar deviation, radial deviation	6 weeks, 12 weeks, and 6 months
Hand Grip Strength	Strength measurement	6 weeks, 12 weeks, and 6 months
Wrist Circumference	Anthropometric measurement	6 weeks, 12 weeks, and 6 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 11330 (REGISTRY: DAIDS-ES)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No