Recruiting
Phase 1

Observational Study

Sponsor:

George Washington University

Code:

NCT05650996

Conditions

Distal Radius Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ADL/Cast Care instruction

Cast Care 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 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.

Conditions

Distal Radius Fracture

Study ID

NCT05650996

Start date

Apr 18, 2023

Status verified date

Feb, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

ADL/Cast Care instruction

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

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.

Primary outcome measure

  • Michigan Hand Questionnaire [ Time Frame: baseline ]
  • Michigan Hand Questionnaire [ Time Frame: 6 weeks ]
  • Michigan Hand Questionnaire [ Time Frame: 9 weeks ]
  • Michigan Hand Questionnaire [ Time Frame: 3 months ]
  • Visual Analog Scale [ Time Frame: baseline ]
  • Visual Analog Scale [ Time Frame: 6 weeks ]
  • Visual Analog Scale [ Time Frame: 9 weeks ]
  • Visual Analog Scale [ Time Frame: 3 months ]
  • Tampa Scale of Kinesiophobia [ Time Frame: baseline ]
  • Tampa Scale of Kinesiophobia [ Time Frame: 6 weeks ]
  • Tampa Scale of Kinesiophobia [ Time Frame: 9 weeks ]
  • Tampa Scale of Kinesiophobia [ Time Frame: 3 months ]
  • Range of motion of digits [ Time Frame: 6 weeks ]
  • Range of motion of digits [ Time Frame: 9 weeks ]
  • Range of motion of digits [ Time Frame: 3 months ]
  • Grip and Pinch Strength [ Time Frame: 9 weeks ]
  • Grip and Pinch Strength [ Time Frame: 3 months ]
  • 9 hole peg test [ Time Frame: 9 weeks ]
  • 9 hole peg test [ Time Frame: 3 months ]

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

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Activities of Daily Living
  • 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 2026-02-12.