Recruiting

Activity Restrictions

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06799377

Conditions

Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Restricted Activity Reccomendations

Full Activity/Limited Activity Reccomendations

Study Details

Brief summary:

The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are:

Does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? Are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? Do activity restrictions provided for pediatric forearm fractures influence patient activity levels?

Participants will be randomized into activity-restricted vs activity-limited (no contact sports). Some patients will be provided an ActiGraph Activity tracker to monitor patient activity. Every patient will complete a validated activity survey (PAQ) to assess activity at each follow-up appointment. Activity data and any complications will be recorded from time of initial presentation to cast removal.

Conditions

Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)

Study ID

NCT06799377

Start date

Jan 16, 2025

Status verified date

Jul, 2025

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)
  • Insolated Radial Shaft Fracture (diaphyseal)
  • Radial and Ulna Shaft Fracture (diaphyseal)

Exclusion Criteria:

  • Initial presentation >7 days from the time of injury
  • Pathologic fracture
  • Any patient with metabolic bone disease (ex. Osteoporosis, skeletal dysplasias)
  • Any patient with known bone fragility condition (ex. Osteogenesis imperfecta)
  • If operative treatment is required at initial presentation

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Restricted Activity Group

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"

active comparator: Activity (Limited) Group

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."

Interventions

Restricted Activity Reccomendations

Patients in this respective group will be given restricted activity recommendations over the casting period. 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"

Full Activity/Limited Activity Reccomendations

Patients in this respective group will be allowed to engage in most activities. They will be read "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."

Primary outcome measure

  • Re-Displacement [ Time Frame: From Cast Placement to Cast Removal, aproximately 6-8 weeks. ]

Central Contacts and Locations

Central contacts

Nathaniel Lempert, M.D.

419-344-3993nathaniel.lempert@vumc.org

James F Bathon, B.S.

914-471-3665

Locations

Vanderbilt Children's Hospital Orthopedics Clinic

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Nathaniel Lempert, M.D.

419-344-3993nathaniel.lempert@vumc.org

James Bathon, B.S.

9144713665james.f.bathon@vanderbilt.edu

Principal Investigator:

Nathaniel Lempert, M.D.

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jul 10, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-07-10.