NCT05650996

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
5mo left

Started Apr 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Apr 2023Sep 2026

First Submitted

Initial submission to the registry

November 28, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

April 18, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

November 28, 2022

Last Update Submit

February 10, 2026

Conditions

Distal Radius Fracture

Keywords

Activities of Daily LivingPatient Education

Outcome Measures

Primary Outcomes (19)

  • Michigan Hand Questionnaire

    Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability

    baseline

  • Michigan Hand Questionnaire

    Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability

    6 weeks

  • Michigan Hand Questionnaire

    Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability

    9 weeks

  • Michigan Hand Questionnaire

    Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability

    3 months

  • Visual Analog Scale

    patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain

    baseline

  • Visual Analog Scale

    patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain

    6 weeks

  • Visual Analog Scale

    patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain

    9 weeks

  • Visual Analog Scale

    patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain

    3 months

  • Tampa Scale of Kinesiophobia

    patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia

    baseline

  • Tampa Scale of Kinesiophobia

    patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia

    6 weeks

  • Tampa Scale of Kinesiophobia

    patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia

    9 weeks

  • Tampa Scale of Kinesiophobia

    patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia

    3 months

  • Range of motion of digits

    distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm

    6 weeks

  • Range of motion of digits

    distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm

    9 weeks

  • Range of motion of digits

    distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm

    3 months

  • Grip and Pinch Strength

    Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength

    9 weeks

  • Grip and Pinch Strength

    Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength

    3 months

  • 9 hole peg test

    fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity

    9 weeks

  • 9 hole peg test

    fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity

    3 months

Study Arms (2)

ADL video/Cast Care

EXPERIMENTAL

ADL/cast care instructional video ADL/cast care handout

Behavioral: ADL/Cast Care instructionBehavioral: Cast Care Instruction

Cast Care Video

ACTIVE COMPARATOR

Cast care instructional video Cast care handout

Behavioral: Cast Care Instruction

Interventions

ADL/Cast Care instructionBEHAVIORAL

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.

ADL video/Cast Care
Cast Care InstructionBEHAVIORAL

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.

ADL video/Cast CareCast Care Video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English Speaking
  • DRFs treated with a cast
  • Individuals over the age of 18
  • Less than 3 weeks from DRF

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Facilities Associates

Washington, Virginia, 22204, United States

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

Sarah Doerrer, PhD

CONTACT

757-651-5110sdoerrer56@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

November 28, 2022

First Posted

December 14, 2022

Study Start

April 18, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)