Effect of Occupational Therapy on the Function and Mobility of Elbow Fractures

Effect of Occupational Therapy on the Function and Mobility in Supracondylar Humerus Fractures: A Randomized Controlled Trial

Supracondylar humerus fracture are common upper extremity injuries in children accounting for over 400 fractures per year and approximately 25% of all fractures treated at Seattle Children's Emergency Department. Most of these fractures are treated with splints and casts though more than one-third undergo surgical fixation followed by casting. Healing is usually complete after 3-4 weeks, when casts (and pins, if fixed operatively) are removed and motion begun. Though stiffness is often a problem after immobilization of adult elbow fractures, stiffness after pediatric elbow fractures is regarded as typically transient. This study addresses the question "Does early motion of the arm with physiotherapy promote the return of function and motion in patients with supracondylar humerus fractures?" The investigators will conduct a prospective randomized trial to determine the effect of six occupational therapy visits over a five week period of time on elbow function and mobility after supracondylar humerus fracture. The investigators will measure motion of the elbow and administer the child and parental Activity Scale for Kids performance versions (ASKp) assessment tool to answer this question.

Study Overview

• Status: Completed
• Conditions: Supracondylar Humerus Fracture
• Intervention / Treatment: Other: Occupational therapy

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have a supracondylar fracture which is isolated, non - comminuted, and less than one week old.
• Will be treated with either casting or surgery.
• Lack head injuries or other fractures.
• Are not cognitively impaired or critically ill.
• Are 5 - 12 years old
• Speak English or Spanish

Exclusion Criteria:

• Requires open reduction to align
• Comminuted or t - intercondylar fracture
• Other fractures on the same limb
• Head injury
• Cognitive impairment
• Critically ill
• Mental disorders
• Fracture occurred more than one week prior to visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Occupational therapy	Other: Occupational therapy; Participants in this arm will receive six sessions of occupational therapy in a 5 week period.
No Intervention: 2; watchful waiting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Activity Scale for Kids performance version (ASKp)	week 1, week 6, week 12, week 24

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: Gregory Schmale, MD, University of Washington - Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 27, 2009
• First Submitted That Met QC Criteria: March 27, 2009
• First Posted (Estimate): March 30, 2009

Study Record Updates

• Last Update Posted (Estimate): July 2, 2012
• Last Update Submitted That Met QC Criteria: June 28, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: AEF-24801