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

Primary Purpose

Supracondylar Humerus Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occupational therapy
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supracondylar Humerus Fracture

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Occupational therapy

watchful waiting

Outcomes

Primary Outcome Measures

Activity Scale for Kids performance version (ASKp)

Secondary Outcome Measures

Full Information

First Posted
March 27, 2009
Last Updated
June 28, 2012
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00871793
Brief Title
Effect of Occupational Therapy on the Function and Mobility of Elbow Fractures
Official Title
Effect of Occupational Therapy on the Function and Mobility in Supracondylar Humerus Fractures: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supracondylar Humerus Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Occupational therapy
Arm Title
2
Arm Type
No Intervention
Arm Description
watchful waiting
Intervention Type
Other
Intervention Name(s)
Occupational therapy
Intervention Description
Participants in this arm will receive six sessions of occupational therapy in a 5 week period.
Primary Outcome Measure Information:
Title
Activity Scale for Kids performance version (ASKp)
Time Frame
week 1, week 6, week 12, week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Schmale, MD
Organizational Affiliation
University of Washington - Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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