Effect of Occupational Therapy on the Function and Mobility of Elbow Fractures
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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 |
- 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 |
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| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
| 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 May 19, 2013