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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gregory Schmale, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00871793
First received: March 27, 2009
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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 Intervention
Supracondylar Humerus Fracture
Other: Occupational therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Occupational Therapy on the Function and Mobility in Supracondylar Humerus Fractures: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Activity Scale for Kids performance version (ASKp) [ Time Frame: week 1, week 6, week 12, week 24 ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: March 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871793

Locations
United States, Washington
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
  More Information

No publications provided

Responsible Party: Gregory Schmale, Associate Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00871793     History of Changes
Other Study ID Numbers: AEF-24801
Study First Received: March 27, 2009
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014