Distal Radius FracturesPhase 1NCT06251206
Impact of Early ADL Education on Outcomes Post DRF ORIF
A Phase 1 study testing ADL/Postoperative Instruction and Postoperative Instruction in people with Distal Radius Fractures, run by George Washington University at 1 site in United States.
Trial summary
This study is a randomized controlled trial (RCT). This RCT which will study the effect of performing daily activities early after a distal radius fracture being treated with surgical intervention of open reduction and internal fixation. This study will have two groups. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- ADL/Postoperative Instruction and Postoperative Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English Speaking DRF treated with ORIF Individuals 18 years of age or older 2 weeks or less post ORIF for DRF
Who cannot join
- Individuals with pre-existing neurological coniditons affecting the upper limb Individuals with congnitive deficits that would limit the ability to correctly report information on outcome measures Individuals with psychological deficits which would limit the ability to correctly report information on outcome measures Individuals with multiple injuries to the affected upper limb Individuals with multiple injuries to both upper limbs Prior distal radius fracture involving the same wrist Individuals receiving hand therapy for another injury at enrollment into study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical Facilities Associates
Washington, Virginia, 22204
Sarah Doerrer, 7576515110, sdoerrer56@gwu.edu
Sam Moghtaderi, smoghtaderi@mfa.gwu.edu
About this study
Official title: Impact of Early Multimodal ADL Education on Outcomes Post Distal Radius Fracture Open Reduction Internal Fixation Surgery
This study is a randomized controlled trial (RCT). This RCT which will study the effect of performing daily activities early after a distal radius fracture being treated with surgical intervention of open reduction and internal fixation. This study will have two groups. The experimental group will watch a video and be given a handout on how to perform daily activities with the hand of the injured wrist while recovering from surgery and postoperative instructions. The control group will watch a video on wound care and be given a handout on postoperative instructions. Outcome measures will be taken at initial evaluation between 1-2 weeks post surgery, at 5-7 weeks post surgery, at 8-10 weeks, and at 12-14 weeks. Outcome measures will include the Michigan Wrist Evaluation, Visual Analog Pain Scale, Tampa Scale of Kinesiophobia-11 Scale, finger mobility testing, grip and pinch strength, and the 9 hole peg test to test fine motor coordination. Outcome measure scores will be compared between groups using a t-test statistical test. Outcome measure scores will also be tested within groups using a paired t-test.
Read the detailed description
- The surgeon will recruit patients who have had surgery for a distal radius fracture with open reduction and internal fixation and have met inclusion and exclusion criteria utilizing a recruitment statement.
- If the patient is interested in participating in the study, the surgeon will obtain informed consent and email a copy of the informed consent form to the patient.
- Once informed consent is obtained, the surgeon will ask the front desk to give him an envelop which will include a letter with either the word control or experimental group on it.
- Once the surgeon reads the letter, the subject will receive either the standard of care video and handout (control) or the intervention video and handout (experimental).
- If the subject receives the intervention then the surgeon will play the intervention video in the office and review with the subject the educational handout. The handout will be given to the subject to take home which includes a QR code to the educational video.
If the subject is in the control group then the surgeon will play the standard of care (postoperative care) video in the office and review with the subject the postoperative care handout. The handout will be given to the subject to take home which includes a QR code to the video.
The following data collection procedures will occur with the subjects
The surgeon will collect data from all subjects at 1-2 weeks post surgery and data collection will include: age, gender, race, hand dominance, side injured, fracture severity, workers comp status, comorbidities, smoker status, work status, and household assistance. The hand surgeon will also collect data from the subjects on their current level of function, pain, and fear of moving their injured limb.
At 5-7 weeks the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion.
At 8-10 weeks the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion, grip, pinch strength and fine motor coordination.
At 12-14 the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion, grip, pinch strength and fine motor coordination.
All subjects will be followed for 14 weeks. If the patient receives a referral for hand therapy it will be noted in the record. It will also be noted in the record if subject experiences any complication such as median nerve compression, tendonitis, or complex regional pain syndrome.
The outcome measures that will be used with both the control and experimental groups and at each time point that the data will be collected. All outcome measures will be uploaded onto RedCap. Subjects will use a tablet to fill out all questionnaires (Michigan Hand Evaluation, Visual Analog Scale, Tampa Scale of Kinesiophobia-11) while in the office or forms will be emailed through RedCap and scores will be uploaded into the RedCap database. All clinical tests (grip and pinch testing, distance from distal palmar crease, 9 hole peg test) will be recorded in RedCap. Demographic information will either be collected on the tablet in RedCap.
- Conditions
- Distal Radius Fractures
- Being tested
- ADL/Postoperative Instruction, Postoperative Instruction
- Keywords
- Activities of Daily Living, Postsurgical Patient Education
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADL/Postoperative InstructionBehavioural
This is an education video which includes demonstration of simple ADL tasks that the participant can do at home after surgery. Handout includes the same information and a QR code to watch the video.
Postoperative InstructionBehavioural
This is an education video that only includes the postoperative instructions. Handout includes the same information and a QR code to watch the video.
| Study group | Role | What they receive |
|---|---|---|
| ADL/Postoperative Instruction | Experimental | Participants in the experimental group will watch a video instructing them on early ADL participation after DRF fracture treated by ORIF and postoperative care. Participants in the experimental group will also receive a handout on ADL participation and postoperative care with a QR code to the video. Receives: Behavioral: ADL/Postoperative Instruction; Behavioral: Postoperative Instruction |
| Postoperative Instruction | Active comparator | Participants in the control group will watch a video instructing them on postoperative care. Participants in the control group will receive a handout on postoperative care with a QR code to the video. Receives: Behavioral: Postoperative Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan Hand Questionnaire
Patient reported outcome measure for function
Measured: baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Secondary outcomes (5)
Visual Analog Scale
patient reported outcome measure for pain intensity
Measured: baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Tampa Scale of Kinesiophobia
patient reported outcome measure for fear of movement
Measured: baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Range of Motion of digits
distance from digits to distal palmar crease in cm
Measured: 5-7 weeks, 8-10 weeks, 12-14 weeks
Grip and Pinch Strength
Jamar grip gauge testing and pinchmeter gauge testing for strength
Measured: 8-10 weeks, 12-14 weeks
9 hole peg test
fine motor coordination/sensorimotor test
Measured: 8-10 weeks, 12-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Aug 2024
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by George Washington 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Doerrer, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251206
- Sponsor's protocol ID
- NCR235402
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Multimodal ADL Education on Outcomes Post Distal Radius Fracture Open Reduction Internal Fixation Surgery
- ClinicalTrials.gov ID
- NCT06251206
- Acronym / sponsor ID
- NCR235402
- Conditions
- Distal Radius Fractures
- Keywords
- Activities of Daily Living, Postsurgical Patient Education
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Feb 2024 (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 study is a randomized controlled trial (RCT). This RCT which will study the effect of performing daily activities early after a distal radius fracture being treated with surgical intervention of open reduction and internal fixation. This study will have two groups. The experimental group will watch a video and be given a handout on how to perform daily activities with the hand of the injured wrist while recovering from surgery and postoperative instructions. The control group will watch a video on wound care and be given a handout on postoperative instructions. Outcome measures will be taken at initial evaluation between 1-2 weeks post surgery, at 5-7 weeks post surgery, at 8-10 weeks, and at 12-14 weeks. Outcome measures will include the Michigan Wrist Evaluation, Visual Analog Pain Scale, Tampa Scale of Kinesiophobia-11 Scale, finger mobility testing, grip and pinch strength, and the 9 hole peg test to test fine motor coordination. Outcome measure scores will be compared between groups using a t-test statistical test. Outcome measure scores will also be tested within groups using a paired t-test.
Detailed description
- The surgeon will recruit patients who have had surgery for a distal radius fracture with open reduction and internal fixation and have met inclusion and exclusion criteria utilizing a recruitment statement.
- If the patient is interested in participating in the study, the surgeon will obtain informed consent and email a copy of the informed consent form to the patient.
- Once informed consent is obtained, the surgeon will ask the front desk to give him an envelop which will include a letter with either the word control or experimental group on it.
- Once the surgeon reads the letter, the subject will receive either the standard of care video and handout (control) or the intervention video and handout (experimental).
- If the subject receives the intervention then the surgeon will play the intervention video in the office and review with the subject the educational handout. The handout will be given to the subject to take home which includes a QR code to the educational video.
If the subject is in the control group then the surgeon will play the standard of care (postoperative care) video in the office and review with the subject the postoperative care handout. The handout will be given to the subject to take home which includes a QR code to the video.
The following data collection procedures will occur with the subjects
The surgeon will collect data from all subjects at 1-2 weeks post surgery and data collection will include: age, gender, race, hand dominance, side injured, fracture severity, workers comp status, comorbidities, smoker status, work status, and household assistance. The hand surgeon will also collect data from the subjects on their current level of function, pain, and fear of moving their injured limb.
At 5-7 weeks the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion.
At 8-10 weeks the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion, grip, pinch strength and fine motor coordination.
At 12-14 the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion, grip, pinch strength and fine motor coordination.
All subjects will be followed for 14 weeks. If the patient receives a referral for hand therapy it will be noted in the record. It will also be noted in the record if subject experiences any complication such as median nerve compression, tendonitis, or complex regional pain syndrome.
The outcome measures that will be used with both the control and experimental groups and at each time point that the data will be collected. All outcome measures will be uploaded onto RedCap. Subjects will use a tablet to fill out all questionnaires (Michigan Hand Evaluation, Visual Analog Scale, Tampa Scale of Kinesiophobia-11) while in the office or forms will be emailed through RedCap and scores will be uploaded into the RedCap database. All clinical tests (grip and pinch testing, distance from distal palmar crease, 9 hole peg test) will be recorded in RedCap. Demographic information will either be collected on the tablet in RedCap.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADL/Postoperative Instruction | Experimental | Behavioral: ADL/Postoperative Instruction, Behavioral: Postoperative InstructionParticipants in the experimental group will watch a video instructing them on early ADL participation after DRF fracture treated by ORIF and postoperative care. Participants in the experimental group will also receive a handout on ADL participation and postoperative care with a QR code to the video. |
| Postoperative Instruction | Active comparator | Behavioral: Postoperative InstructionParticipants in the control group will watch a video instructing them on postoperative care. Participants in the control group will receive a handout on postoperative care with a QR code to the video. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English Speaking DRF treated with ORIF Individuals 18 years of age or older 2 weeks or less post ORIF for DRF
Key exclusion criteria (1 listed)
- Individuals with pre-existing neurological coniditons affecting the upper limb Individuals with congnitive deficits that would limit the ability to correctly report information on outcome measures Individuals with psychological deficits which would limit the ability to correctly report information on outcome measures Individuals with multiple injuries to the affected upper limb Individuals with multiple injuries to both upper limbs Prior distal radius fracture involving the same wrist Individuals receiving hand therapy for another injury at enrollment into study
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 |
|---|---|---|
| ADL/Postoperative InstructionThis is an education video which includes demonstration of simple ADL tasks that the participant can do at home after surgery. Handout includes the same information and a QR code to watch the video. | Behavioural | ADL/Postoperative Instruction |
| Postoperative InstructionThis is an education video that only includes the postoperative instructions. Handout includes the same information and a QR code to watch the video. | Behavioural | ADL/Postoperative Instruction, Postoperative Instruction |
Primary outcome
Michigan Hand Questionnaire
Time frame: baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Patient reported outcome measure for function
5 secondary outcomes
Visual Analog Scale
Time frame: baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Tampa Scale of Kinesiophobia
Time frame: baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Range of Motion of digits
Time frame: 5-7 weeks, 8-10 weeks, 12-14 weeks
Grip and Pinch Strength
Time frame: 8-10 weeks, 12-14 weeks
9 hole peg test
Time frame: 8-10 weeks, 12-14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADL/Postoperative Instruction and Postoperative Instruction in people with Distal Radius Fractures, run by George Washington University at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Doerrer, PhD (757-651-5110, sdoerrer56@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Michigan Hand Questionnaire (time frame: baseline, 5-7 weeks, 8-10 weeks, 12-14 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 19 Oct 2026.