Recruiting
Phase 1

ADL Education

Sponsor:

George Washington University

Code:

NCT06251206

Conditions

Distal Radius Fractures

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

ADL/Postoperative Instruction

Postoperative Instruction

Study Details

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

Study ID

NCT06251206

Start date

Aug 1, 2024

Status verified date

Aug, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

ADL/Postoperative Instruction

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

This is an education video that only includes the postoperative instructions. Handout includes the same information and a QR code to watch the video.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Medical Facilities Associates

Recruiting

Washington, Virginia, United States, 22204

Contacts

More Information

Sponsor

George Washington University

Last update posted

Aug 13, 2026

Last verified

Aug, 2025

Keywords

  • Activities of Daily Living
  • Postsurgical Patient Education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Washington University on 2026-08-13.