Impact of Early ADL Participation on Outcomes Post DRF

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Early ADL Participation on Functional Outcomes Post Distal Radius Fracture

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Behavioral: ADL/Cast Care instruction
* Behavioral: Cast Care Instruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADL video<br>ADL/cast care instructional video ADL/cast care handout | Behavioral: ADL/Cast Care instruction<br>* 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.<br>Behavioral: Cast Care Instruction<br>* 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.<br>|
| Sham Comparator: Sham Video<br>Cast care instructional video Cast care handout | Behavioral: Cast Care Instruction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |