Distal Radius FracturePhase 1NCT05650996
Impact of Early ADL Participation on Outcomes Post DRF
A Phase 1 study testing ADL/Cast Care instruction and Cast Care Instruction in people with Distal Radius Fracture, 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 conservatively in a cast. This study will have two groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- ADL/Cast Care instruction and Cast Care Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2023to 1 Oct 2026
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English Speaking
- DRFs treated with a cast
- Individuals over the age of 18
- Less than 3 weeks from DRF
Who cannot join
- Individuals with pre-existing neurological conditions affecting the upper limb
- Individuals with cognitive 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
- Individuals requiring surgery to fixate the distal radius fracture
- 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.
United States1 site
Medical Facilities Associates
Washington, Virginia, 22204
About this study
Official title: The Impact of Early ADL Participation on Functional Outcomes Post Distal Radius Fracture
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 conservatively in a cast. 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 in a cast and cast care. The control group will watch a video on cast care and be given a handout on cast care. Outcome measures will be taken at initial evaluation between 0-3 weeks, at 6 weeks, at 9 weeks, and at 3 months. 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 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 and a link to the handout and video will be emailed to the subject.
- If the subject is in the control group then the surgeon will play the standard of care (cast care) video in the office and review with the subject the cast care handout. The handout will be given to the subject to take home and a link to the handout and video will be emailed to the subject.
The following data collection procedures will occur with the subjects
The surgeon will collect data from all subjects at 0-3 weeks post injury 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 6 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 9 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 3 months 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 3 months. If at 6 weeks or later 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 Fracture
- Being tested
- ADL/Cast Care instruction, Cast Care Instruction
- Keywords
- Activities of Daily Living, 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/Cast Care instructionBehavioural
Participants in the experimental group will watch a video instructing them on early ADL participation after DRF fracture treated in a cast and cast care. Participants in the experimental group will also receive a handout on ADL participation and cast care.
Cast Care InstructionBehavioural
Participants in the control group will watch a video instructing them on cast care. Participants in the control group will receive a handout on cast care.
| Study group | Role | What they receive |
|---|---|---|
| ADL video/Cast Care | Experimental | ADL/cast care instructional video ADL/cast care handout Receives: Behavioral: ADL/Cast Care instruction; Behavioral: Cast Care Instruction |
| Cast Care Video | Active comparator | Cast care instructional video Cast care handout Receives: Behavioral: Cast Care 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, min value-0 max value-100 , higher score is best possible ability
Measured: baseline
Michigan Hand Questionnaire
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Measured: 6 weeks
Michigan Hand Questionnaire
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Measured: 9 weeks
Michigan Hand Questionnaire
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Measured: 3 months
Visual Analog Scale
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Measured: baseline
Visual Analog Scale
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Measured: 6 weeks
Visual Analog Scale
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Measured: 9 weeks
Visual Analog Scale
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Measured: 3 months
Tampa Scale of Kinesiophobia
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Measured: baseline
Tampa Scale of Kinesiophobia
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Measured: 6 weeks
Tampa Scale of Kinesiophobia
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Measured: 9 weeks
Tampa Scale of Kinesiophobia
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Measured: 3 months
Range of motion of digits
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Measured: 6 weeks
Range of motion of digits
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Measured: 9 weeks
Range of motion of digits
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Measured: 3 months
Grip and Pinch Strength
Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength
Measured: 9 weeks
Grip and Pinch Strength
Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength
Measured: 3 months
9 hole peg test
fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity
Measured: 9 weeks
9 hole peg test
fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start18 Apr 2023
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
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 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- American Hand Therapy Foundation
- Responsible party
- Principal investigator, Sarah Doerrer, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650996
- Sponsor's protocol ID
- NCR224559
- Status last verified
- Oct 2026
- First submitted
- 28 Nov 2022
- 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
- The Impact of Early ADL Participation on Functional Outcomes Post Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT05650996
- Acronym / sponsor ID
- NCR224559
- Conditions
- Distal Radius Fracture
- Keywords
- Activities of Daily Living, Patient Education
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- American Hand Therapy Foundation
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 14 Dec 2022 (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 conservatively in a cast. 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 in a cast and cast care. The control group will watch a video on cast care and be given a handout on cast care. Outcome measures will be taken at initial evaluation between 0-3 weeks, at 6 weeks, at 9 weeks, and at 3 months. 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 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 and a link to the handout and video will be emailed to the subject.
- If the subject is in the control group then the surgeon will play the standard of care (cast care) video in the office and review with the subject the cast care handout. The handout will be given to the subject to take home and a link to the handout and video will be emailed to the subject.
The following data collection procedures will occur with the subjects
The surgeon will collect data from all subjects at 0-3 weeks post injury 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 6 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 9 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 3 months 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 3 months. If at 6 weeks or later 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 video/Cast Care | Experimental | Behavioral: ADL/Cast Care instruction, Behavioral: Cast Care InstructionADL/cast care instructional video ADL/cast care handout |
| Cast Care Video | Active comparator | Behavioral: Cast Care InstructionCast care instructional video Cast care handout |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English Speaking
- DRFs treated with a cast
- Individuals over the age of 18
- Less than 3 weeks from DRF
Key exclusion criteria (8 listed)
- Individuals with pre-existing neurological conditions affecting the upper limb
- Individuals with cognitive 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
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/Cast Care instructionParticipants in the experimental group will watch a video instructing them on early ADL participation after DRF fracture treated in a cast and cast care. Participants in the experimental group will also receive a handout on ADL participation and cast care. | Behavioural | ADL video/Cast Care |
| Cast Care InstructionParticipants in the control group will watch a video instructing them on cast care. Participants in the control group will receive a handout on cast care. | Behavioural | ADL video/Cast Care, Cast Care Video |
Primary outcome
Michigan Hand Questionnaire
Time frame: baseline
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Michigan Hand Questionnaire
Time frame: 6 weeks
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Michigan Hand Questionnaire
Time frame: 9 weeks
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Michigan Hand Questionnaire
Time frame: 3 months
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Visual Analog Scale
Time frame: baseline
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Visual Analog Scale
Time frame: 6 weeks
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Visual Analog Scale
Time frame: 9 weeks
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Visual Analog Scale
Time frame: 3 months
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Tampa Scale of Kinesiophobia
Time frame: baseline
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Tampa Scale of Kinesiophobia
Time frame: 6 weeks
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Tampa Scale of Kinesiophobia
Time frame: 9 weeks
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Tampa Scale of Kinesiophobia
Time frame: 3 months
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Range of motion of digits
Time frame: 6 weeks
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Range of motion of digits
Time frame: 9 weeks
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Range of motion of digits
Time frame: 3 months
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Grip and Pinch Strength
Time frame: 9 weeks
Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength
Grip and Pinch Strength
Time frame: 3 months
Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength
9 hole peg test
Time frame: 9 weeks
fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity
9 hole peg test
Time frame: 3 months
fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity
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 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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/Cast Care instruction and Cast Care Instruction in people with Distal Radius Fracture, 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 4 inclusion and 8 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 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?
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?
Michigan Hand Questionnaire (time frame: baseline). The study lists 19 primary outcomes in all. 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.