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

• Sponsor: Seattle Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00871793
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Mar 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Activity Scale for Kids performance version (ASKp) [week 1, week 6, week 12, week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 12 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seattle Children's Hospital	Seattle	Washington	United States	98105

Sponsors and Collaborators

• Seattle Children's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gregory Schmale, Associate Professor, Seattle Children's Hospital
• ClinicalTrials.gov Identifier: NCT00871793
• Other Study ID Numbers: AEF-24801
• First Posted: Mar 30, 2009
• Last Update Posted: Jul 2, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Fractures, Bone; Humeral Fractures

Study Results

No Results Posted as of Jul 2, 2012