NCT04194749

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

2.6 years

First QC Date

December 2, 2019

Last Update Submit

December 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

    6 weeks, 6 months

  • Visual Analog Pain Scale

    6 weeks, 12 weeks, and 6 months

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

    6 weeks, 12 weeks, and 6 months

  • Wrist Range of Motion

    6 weeks, 12 weeks, and 6 months

  • Hand Grip Strength

    6 weeks, 12 weeks, and 6 months

  • +1 more secondary outcomes

Study Arms (2)

Digital Media Therapy

EXPERIMENTAL

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

Traditional Therapy

ACTIVE COMPARATOR

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

Other: Traditional Physical Therapy

Interventions

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.

Digital Media Therapy

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

Traditional Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing operative treatment for distal radius fractures.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 11, 2019

Study Start

December 1, 2015

Primary Completion

June 30, 2018

Study Completion

April 30, 2019

Last Updated

December 11, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share