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Impact of Early ADL Participation on Outcomes Post DRF

Primary Purpose

Distal Radius Fracture

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
ADL/Cast Care instruction
Cast Care Instruction
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Distal Radius Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical Facilities AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ADL video

Sham Video

Arm Description

ADL/cast care instructional video ADL/cast care handout

Cast care instructional video Cast care handout

Outcomes

Primary Outcome Measures

Michigan Hand Questionnaire
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Michigan Hand Questionnaire
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Michigan Hand Questionnaire
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Michigan Hand Questionnaire
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Visual Analog Scale
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Visual Analog Scale
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Visual Analog Scale
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Visual Analog Scale
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Tampa Scale of Kinesiophobia
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Tampa Scale of Kinesiophobia
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Tampa Scale of Kinesiophobia
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Tampa Scale of Kinesiophobia
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
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
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
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
Grip and Pinch Strength
Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength
Grip and Pinch Strength
Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength
9 hole peg test
fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity
9 hole peg test
fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity

Secondary Outcome Measures

Full Information

First Posted
November 28, 2022
Last Updated
April 28, 2023
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT05650996
Brief Title
Impact of Early ADL Participation on Outcomes Post DRF
Official Title
The Impact of Early ADL Participation on Functional Outcomes Post Distal Radius Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The surgeon will recruit patients who have met inclusion and exclusion criteria utilizing a recruitment statement. If the patient is interested in participating in the study, the surgeon will obtain informed consent and email a copy of the informed consent form to the patient. Once informed consent is obtained, the surgeon will ask the front desk to give him an envelop which will include a letter with either the word control or experimental group on it. Once the surgeon reads the letter, the subject will receive either the standard of care video and handout (control) or the intervention video and handout (experimental). If the subject receives the intervention then the surgeon will play the intervention video in the office and review with the subject the educational handout. The handout will be given to the subject to take home and a link to the handout and video will be emailed to the subject. If the subject is in the control group then the surgeon will play the standard of care (cast care) video in the office and review with the subject the cast care handout. The handout will be given to the subject to take home and a link to the handout and video will be emailed to the subject. The following data collection procedures will occur with the subjects The surgeon will collect data from all subjects at 0-3 weeks post injury and data collection will include: age, gender, race, hand dominance, side injured, fracture severity, workers comp status, comorbidities, smoker status, work status, and household assistance. The hand surgeon will also collect data from the subjects on their current level of function, pain, and fear of moving their injured limb. At 6 weeks the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion. At 9 weeks the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion, grip, pinch strength and fine motor coordination. At 3 months the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion, grip, pinch strength and fine motor coordination. All subjects will be followed for 3 months. If at 6 weeks or later the patient receives a referral for hand therapy it will be noted in the record. It will also be noted in the record if subject experiences any complication such as median nerve compression, tendonitis, or complex regional pain syndrome. The outcome measures that will be used with both the control and experimental groups and at each time point that the data will be collected. All outcome measures will be uploaded onto RedCap. Subjects will use a tablet to fill out all questionnaires (Michigan Hand Evaluation, Visual Analog Scale, Tampa Scale of Kinesiophobia-11) while in the office or forms will be emailed through EPIC and scores will be transferred into the RedCap database. All clinical tests (grip and pinch testing, distance from distal palmar crease, 9 hole peg test) will be recorded in RedCap. Demographic information will either be collected through EPIC or collected on the tablet in RedCap.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADL video
Arm Type
Experimental
Arm Description
ADL/cast care instructional video ADL/cast care handout
Arm Title
Sham Video
Arm Type
Sham Comparator
Arm Description
Cast care instructional video Cast care handout
Intervention Type
Behavioral
Intervention Name(s)
ADL/Cast Care instruction
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cast Care Instruction
Intervention Description
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 Information:
Title
Michigan Hand Questionnaire
Description
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Time Frame
baseline
Title
Michigan Hand Questionnaire
Description
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Time Frame
6 weeks
Title
Michigan Hand Questionnaire
Description
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Time Frame
9 weeks
Title
Michigan Hand Questionnaire
Description
Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability
Time Frame
3 months
Title
Visual Analog Scale
Description
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Time Frame
baseline
Title
Visual Analog Scale
Description
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Time Frame
6 weeks
Title
Visual Analog Scale
Description
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Time Frame
9 weeks
Title
Visual Analog Scale
Description
patient reported outcome measure for pain intensity, max value=100, min value=0, higher score is more pain
Time Frame
3 months
Title
Tampa Scale of Kinesiophobia
Description
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Time Frame
baseline
Title
Tampa Scale of Kinesiophobia
Description
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Time Frame
6 weeks
Title
Tampa Scale of Kinesiophobia
Description
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Time Frame
9 weeks
Title
Tampa Scale of Kinesiophobia
Description
patient reported outcome measure for fear of movement, min score=11 max score=44, higher score indicates more kinesiophobia
Time Frame
3 months
Title
Range of motion of digits
Description
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Time Frame
6 weeks
Title
Range of motion of digits
Description
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Time Frame
9 weeks
Title
Range of motion of digits
Description
distance from digits to distal palmar crease, min score=0, score of 0 signifies that the individual can touch the palm
Time Frame
3 months
Title
Grip and Pinch Strength
Description
Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength
Time Frame
9 weeks
Title
Grip and Pinch Strength
Description
Jamar grip gauge testing and pinchmeter gauge testing for strength. Min score=0, higher score indicates more strength
Time Frame
3 months
Title
9 hole peg test
Description
fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity
Time Frame
9 weeks
Title
9 hole peg test
Description
fine motor coordination/sensorimotor test. Timed test therefore a longer time to complete reflects reduced finger dexterity
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Doerrer, PhD
Phone
757-651-5110
Email
sdoerrer56@gwu.edu
Facility Information:
Facility Name
Medical Facilities Associates
City
Washington
State/Province
Virginia
ZIP/Postal Code
22204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Doerrer
Phone
757-651-5110
Email
sdoerrer56@gwu.edu
First Name & Middle Initial & Last Name & Degree
Sam Moghtaderi
Email
smoghtaderi@mfa.gwu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Early ADL Participation on Outcomes Post DRF

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