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Digital Media Based Physical Therapy Post Distal Radius Fracture

Primary Purpose

Distal Radius Fracture

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Digital Media Based Physical Therapy

Traditional Physical Therapy

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

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

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital Media Therapy

Traditional Therapy

Arm Description

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.

The traditional group will have clinic-based physical therapy protocol.

Outcomes

Primary Outcome Measures

Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)

Patient-Reported Outcome, Scale: 0 (no disability) - 100 (most severe disability)

Secondary Outcome Measures

Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)

Patient-Reported Outcome, Scale: 0 (no disability) - 100 (most severe disability)

Visual Analog Pain Scale

Patient-Reported Outcome, Scale: 0 (no pain) - 10 (most severe pain)

Veterans RAND 12-item Health Survey (VR-12)

Patient-Reported Outcome

Wrist Range of Motion

Wrist flexion, extension, pronation, supination, ulnar deviation, radial deviation

Hand Grip Strength

Strength measurement

Wrist Circumference

Anthropometric measurement

Full Information

NCT ID

NCT04194749

First Posted

December 2, 2019

Last Updated

December 9, 2019

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT04194749

Brief Title

Digital Media Based Physical Therapy Post Distal Radius Fracture

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

December 1, 2015 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Digital Media Therapy

Arm Type

Experimental

Arm Description

Arm Title

Traditional Therapy

Arm Type

Active Comparator

Arm Description

The traditional group will have clinic-based physical therapy protocol.

Intervention Type

Other

Intervention Name(s)

Digital Media Based Physical Therapy

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Traditional Physical Therapy

Intervention Description

This intervention is a 12 week therapist supervised clinic-based therapy protocol.

Primary Outcome Measure Information:

Title

Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)

Description

Patient-Reported Outcome, Scale: 0 (no disability) - 100 (most severe disability)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)

Description

Patient-Reported Outcome, Scale: 0 (no disability) - 100 (most severe disability)

Time Frame

6 weeks, 6 months

Title

Visual Analog Pain Scale

Description

Patient-Reported Outcome, Scale: 0 (no pain) - 10 (most severe pain)

Time Frame