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Behavioural Intervention

Activity Levels for Forearm Fractures (CRABB-Y Trial)

Nashville, TN
N/A
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Isolated Distal Radius Metaphyseal Fx (with or without ulna styloid)
Distal Third (<4 cm from physis) Radius and Ulna fracture (i.e. without obvious physeal involvement)
Must not have
Any patient with known bone fragility condition (e.g. Osteogenesis imperfecta)
Pathologic fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from casting to cast removal, approximately 6-8 weeks.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the effect of activity on the re-displacement of forearm fractures in children aged 8-18 years old. They want to know if increased activity leads to more re-displacement

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Who is the study for?
This trial is for children aged 8-18 with forearm fractures, excluding those with metabolic bone diseases or a refracture. It's designed to see if being more active affects how the fracture heals and whether it moves out of place again.Check my eligibility
What is being tested?
The study compares two approaches: one group will have limited activity recommendations while the other has restricted activities (no contact sports). An ActiGraph tracker and activity surveys will monitor their movement levels to see if this influences healing or leads to complications.See study design
What are the potential side effects?
There are no medicinal side effects as this trial involves activity recommendations rather than drugs. However, potential risks include skin irritation, need for re-casting, or surgery due to increased activity possibly affecting fracture displacement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a broken wrist near the end of the bone.
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My wrist fracture is close to the joint without affecting the growth area.
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I have a broken bone in the middle of my forearm.
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I have fractures in the middle of my forearm bones.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that makes my bones fragile, like Osteogenesis Imperfecta.
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I have had a fracture due to weakened bones from my condition.
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I have a bone condition like osteoporosis.
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I needed surgery as my first treatment.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from casting to cast removal, approximately 6-8 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from casting to cast removal, approximately 6-8 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Re-Displacement
Secondary study objectives
Activity Level as measured by patient-completed validated activity surveys (PAQ)
Activity Level as measured by patient-worn activity trackers
Complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Restricted Activity GroupActive Control1 Intervention
This group of patients will be given restricted activity recommendations. They will be told: "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "restricted activity" group. We ask that you limit sprinting, jumping, and organized sports during the time of cast immobilization. As a rule of thumb, we recommend "feet on the floor" activities while playing and avoiding playgrounds and gym class if possible. While it is not realistic to restrict a young child entirely, do your best to avoid strenuous or intense exercise until cleared by your physician or nurse practitioner"
Group II: Activity (Limited) GroupActive Control1 Intervention
This group of patients will be given limited activity recommendations. They will be told "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "activity as tolerated" group. Your child may participate in all desired activities except contact sports. Your child does not need to increase his/her activity level but should participate in activities as they feel comfortable doing so. Sprinting, jumping, and organized sports are acceptable as long as your child is not experiencing pain. Your child may use playgrounds and participate in gym class as desired. Do your best to avoid restricting your child from activities unless they are experiencing pain or you have concerns about their safety."

Find a Location

Closest Location:Vanderbilt Children's Hospital Orthopedics Clinic· Nashville, TN· 620 miles

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
918 Previous Clinical Trials
938,660 Total Patients Enrolled
~50 spots leftby Jun 2025