Impact of Early ADL Education on Outcomes Post DRF ORIF

Part of paid clinical trials in Washington, Virginia.

Sponsor
George Washington University
Study ID
NCT06251206
Phase
PHASE1
Status
Recruiting
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Conditions

  • Distal Radius Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Accepted

Interventions

  • ADL/Postoperative Instruction — BEHAVIORAL
    This is an education video which includes demonstration of simple ADL tasks that the participant can do at home after surgery. Handout includes the same information and a QR code to watch the video.
  • Postoperative Instruction — BEHAVIORAL
    This is an education video that only includes the postoperative instructions. Handout includes the same information and a QR code to watch the video.

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 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.

Key Dates

Start date
Aug 1, 2024
Status verified
Aug 2025
Primary completion
May 31, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Experimental: ADL/Postoperative Instruction
    Participants in the experimental group will watch a video instructing them on early ADL participation after DRF fracture treated by ORIF and postoperative care. Participants in the experimental group will also receive a handout on ADL participation and postoperative care with a QR code to the video.
  • Active Comparator: Postoperative Instruction
    Participants in the control group will watch a video instructing them on postoperative care. Participants in the control group will receive a handout on postoperative care with a QR code to the video.

Primary Outcome Measure

Michigan Hand Questionnaire [ Time Frame: baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical Facilities AssociatesWashingtonVirginia22204
Sarah Doerrer
[email protected]
757-651-5110
Sam Moghtaderi
[email protected]

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By research site
Medical Facilities Associates· Washington, VA

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