NCT05650996 Impact of Early ADL Participation on Outcomes Post DRF
| NCT ID | NCT05650996 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | George Washington University |
| Condition | Distal Radius Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2023-04-18 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 2023-04-18 with a primary completion date of 2026-09-01.
⚠ 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 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.
Eligibility Criteria
Inclusion Criteria: English Speaking DRFs treated with a cast Individuals over the age of 18 Less than 3 weeks from DRF Exclusion Criteria: 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05650996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Distal Radius Fracture. 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 NCT05650996 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 NCT05650996 currently recruiting?
Yes, NCT05650996 is actively recruiting participants. Contact the research team at sdoerrer56@gwu.edu for enrollment information.
Where is the NCT05650996 trial being conducted?
This trial is being conducted at Washington, United States.
Who is sponsoring the NCT05650996 clinical trial?
NCT05650996 is sponsored by George Washington University. The trial plans to enroll 64 participants.