NCT06251206 Impact of Early ADL Education on Outcomes Post DRF ORIF
| NCT ID | NCT06251206 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | George Washington University |
| Condition | Distal Radius Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 64 participants in total. It began in 2024-08-01 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: English Speaking DRF treated with ORIF Individuals 18 years of age or older 2 weeks or less post ORIF for DRF Exclusion Criteria: 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06251206 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Distal Radius Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06251206 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06251206 currently recruiting?
Yes, NCT06251206 is actively recruiting participants. Contact the research team at sdoerrer56@gwu.edu for enrollment information.
Where is the NCT06251206 trial being conducted?
This trial is being conducted at Washington, United States.
Who is sponsoring the NCT06251206 clinical trial?
NCT06251206 is sponsored by George Washington University. The trial plans to enroll 64 participants.