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NCT05650996 · ClinicalTrials.gov registry record · Phase 1

Impact of Early ADL Participation on Outcomes Post DRF

A Phase 1 study of Distal Radius Fracture, sponsored by George Washington University.

Recruiting
Registry status
Phase 1
Development phase
64
Enrollment target
1
Study location

NCT05650996 is a Phase 1 study of Distal Radius Fracture that is actively recruiting participants, run by George Washington University. The registered enrollment target is 64 participants, below the 246-participant average among 11 other Distal Radius Fracture trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05650996, a Phase 1 study of Distal Radius Fracture, is actively recruiting participants, sponsored by George Washington University.

RECRUITING
Registry status
Phase 1
Development phase
64 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • BEHAVIORAL ADL/Cast Care instruction
  • BEHAVIORAL Cast Care Instruction

Study Locations (1)

Virginia

  • Medical Facilities Associates - Washington

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2023-04-18
Est. Completion 2026-09-30
Phase Phase 1

Sponsor

George Washington University

133 total trials

What the Registry Record Tells You About NCT05650996

The ClinicalTrials.gov registry entry for NCT05650996 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 246-participant average among 11 other Distal Radius Fracture trials with a reported enrollment target (74% lower). The listed sponsor is George Washington University, which has 133 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Distal Radius Fracture appearing as the primary indexed condition, and to 2 interventions - of which ADL/Cast Care instruction is the first listed.

NCT05650996 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT05650996 about?

NCT05650996 is a clinical study titled "Impact of Early ADL Participation on Outcomes Post DRF". 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...

What is the current status of trial NCT05650996?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2023-04-18. Estimated completion is 2026-09-30.

What conditions does trial NCT05650996 study?

This clinical trial studies the following conditions: Distal Radius Fracture.

What interventions are being tested in trial NCT05650996?

The interventions under investigation include: ADL/Cast Care instruction (BEHAVIORAL), Cast Care Instruction (BEHAVIORAL).

Who is sponsoring clinical trial NCT05650996?

This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05650996 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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