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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871793
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
Gregory Schmale, Seattle Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Supracondylar Humerus Fracture Other: Occupational therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Occupational Therapy on the Function and Mobility in Supracondylar Humerus Fractures: A Randomized Controlled Trial
Study Start Date : March 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Activity Scale for Kids performance version (ASKp) [ Time Frame: week 1, week 6, week 12, week 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00871793

United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Principal Investigator: Gregory Schmale, MD University of Washington - Seattle Children's Hospital

Responsible Party: Gregory Schmale, Associate Professor, Seattle Children's Hospital Identifier: NCT00871793     History of Changes
Other Study ID Numbers: AEF-24801
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries