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Recruiting Phase 1 NCT05650996

NCT05650996 Impact of Early ADL Participation on Outcomes Post DRF

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Clinical Trial Summary
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

Trial Parameters

Condition Distal Radius Fracture
Sponsor George Washington University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 64
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-04-18
Completion 2026-09-01
Interventions
ADL/Cast Care instructionCast Care Instruction

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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

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