Impact of Early ADL Participation on Outcomes Post DRF

Part of paid clinical trials in Washington, Virginia.

Sponsor
George Washington University
Study ID
NCT05650996
Phase
PHASE1
Status
Recruiting
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Conditions

  • Distal Radius Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

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.

Key Dates

Start date
Apr 18, 2023
Status verified
Feb 2026
Primary completion
Sep 1, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: ADL video/Cast Care
    ADL/cast care instructional video ADL/cast care handout
  • Active Comparator: Cast Care Video
    Cast care instructional video Cast care handout

Primary Outcome Measure

Michigan Hand Questionnaire [ Time Frame: baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical Facilities AssociatesWashingtonVirginia22204
Sarah Doerrer
[email protected]
7576515110
Sam Moghtaderi
[email protected]

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Medical Facilities Associates· Washington, VA

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