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

Supracondylar Humerus Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871793
• Other study ID #: AEF-24801
• Status: Completed
• Phase: N/A
• First received: March 27, 2009
• Last updated: June 28, 2012
• Start date: March 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2012
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Supracondylar Humerus Fracture

Intervention

Other:
• Occupational therapy
Participants in this arm will receive six sessions of occupational therapy in a 5 week period.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity Scale for Kids performance version (ASKp)		week 1, week 6, week 12, week 24	No