Distal Radius FractureNCT04194749
Digital Media Based Physical Therapy Post Distal Radius Fracture
A study testing Digital Media Based Physical Therapy and Traditional Physical Therapy in people with Distal Radius Fracture, run by Oregon Health and Science University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Digital Media Based Physical Therapy and Traditional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing operative treatment for distal radius fractures.
Who cannot join
- 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.
About this study
Official title: 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
- Conditions
- Distal Radius Fracture
- Being tested
- Digital Media Based Physical Therapy, Traditional Physical Therapy
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Media Based Physical TherapyOther
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.
Traditional Physical TherapyOther
This intervention is a 12 week therapist supervised clinic-based therapy protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digital Media Based Physical Therapy |
| Traditional Therapy | Active comparator | The traditional group will have clinic-based physical therapy protocol. Receives: Other: Traditional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Patient-Reported Outcome, Scale: 0 (no disability) - 100 (most severe disability)
Measured: 12 weeks
Secondary outcomes (6)
Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Patient-Reported Outcome, Scale: 0 (no disability) - 100 (most severe disability)
Measured: 6 weeks, 6 months
Visual Analog Pain Scale
Patient-Reported Outcome, Scale: 0 (no pain) - 10 (most severe pain)
Measured: 6 weeks, 12 weeks, and 6 months
Veterans RAND 12-item Health Survey (VR-12)
Patient-Reported Outcome
Measured: 6 weeks, 12 weeks, and 6 months
Wrist Range of Motion
Wrist flexion, extension, pronation, supination, ulnar deviation, radial deviation
Measured: 6 weeks, 12 weeks, and 6 months
Hand Grip Strength
Strength measurement
Measured: 6 weeks, 12 weeks, and 6 months
Wrist Circumference
Anthropometric measurement
Measured: 6 weeks, 12 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Dec 2015
- Primary completion30 Jun 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam J. MIrarchi, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194749
- Sponsor's protocol ID
- 11330
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy After Distal Radius Fracture; Traditional Versus Digital Media Based Therapy Protocol
- ClinicalTrials.gov ID
- NCT04194749
- Acronym / sponsor ID
- 11330
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Media Therapy | Experimental | Other: Digital Media Based Physical TherapyThe 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. |
| Traditional Therapy | Active comparator | Other: Traditional Physical TherapyThe traditional group will have clinic-based physical therapy protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing operative treatment for distal radius fractures.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Media Based Physical TherapyThis 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. | Other | Digital Media Therapy |
| Traditional Physical TherapyThis intervention is a 12 week therapist supervised clinic-based therapy protocol. | Other | Traditional Therapy |
Primary outcome
Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time frame: 12 weeks
Patient-Reported Outcome, Scale: 0 (no disability) - 100 (most severe disability)
6 secondary outcomes
Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time frame: 6 weeks, 6 months
Visual Analog Pain Scale
Time frame: 6 weeks, 12 weeks, and 6 months
Veterans RAND 12-item Health Survey (VR-12)
Time frame: 6 weeks, 12 weeks, and 6 months
Wrist Range of Motion
Time frame: 6 weeks, 12 weeks, and 6 months
Hand Grip Strength
Time frame: 6 weeks, 12 weeks, and 6 months
Wrist Circumference
Time frame: 6 weeks, 12 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Media Based Physical Therapy and Traditional Physical Therapy in people with Distal Radius Fracture, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.