Impact of Early ADL Education on Outcomes Post DRF ORIF

NCT06251206 | Recruiting Phase 1

• 1 other identifier: NCR235402
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Distal Radius Fractures

Keywords

Activities of Daily Living; Postsurgical Patient Education

Outcome Measures

Primary Outcomes (1)

• Michigan Hand Questionnaire

  Patient reported outcome measure for function

  baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks

Secondary Outcomes (5)

• Visual Analog Scale

  baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks

• Tampa Scale of Kinesiophobia

  baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks

• Range of Motion of digits

  5-7 weeks, 8-10 weeks, 12-14 weeks

• Grip and Pinch Strength

  8-10 weeks, 12-14 weeks

• 9 hole peg test

  8-10 weeks, 12-14 weeks

Study Arms (2)

ADL/Postoperative Instruction

EXPERIMENTAL

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.

Behavioral: ADL/Postoperative Instruction; Behavioral: Postoperative Instruction

Postoperative Instruction

ACTIVE COMPARATOR

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.

Behavioral: Postoperative Instruction

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.

ADL/Postoperative Instruction

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.

ADL/Postoperative Instruction; Postoperative Instruction

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Speaking DRF treated with ORIF Individuals 18 years of age or older 2 weeks or less post ORIF for DRF

You may not qualify if:

• Individuals with pre-existing neurological coniditons affecting the upper limb Individuals with congnitive 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 Prior distal radius fracture involving the same wrist Individuals receiving hand therapy for another injury at enrollment into study

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

Medical Facilities Associates

Washington, Virginia, 22204, United States

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

Sarah Doerrer, PhD

CONTACT

757-651-5110; sdoerrer56@gwu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: August 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)