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

NCT00871793 | Completed

• 1 other identifier: AEF-24801
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Supracondylar Humerus Fracture

Outcome Measures

Primary Outcomes (1)

• Activity Scale for Kids performance version (ASKp)

  week 1, week 6, week 12, week 24

Study Arms (2)

1

ACTIVE COMPARATOR

Occupational therapy

Other: Occupational therapy

2

NO INTERVENTION

watchful waiting

Interventions

Occupational therapy OTHER

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

1

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

Occupational Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Gregory Schmale, MD

  University of Washington - Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

US (1)