Evaluation of Hand Assessments in Children With Severe Hand Burns

Burns Clinical Trial

Official title:

Evaluation of Hand Assessments in Children With Severe Hand Burns

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00363675
• Other study ID #: 2006-P000388/3
• Status: Terminated
• Phase: N/A
• First received: August 9, 2006
• Last updated: February 29, 2012
• Start date: August 2006
• Est. completion date: August 2011

Study information

• Verified date: February 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is designed to see if some tests of hand movement, strength, and function are valid for children with burns.

Description:

Children will be given a battery of tests to determine the validity of these measures for children with severe hand burns. The tests include:

• Pinch and grip strength;

• Stereognosis;

• Speed of manipulation using the Nine Hole Peg Test, Box & Blocks Test, and the Moberg Pickup Test;

• Measurement of Range of Motion of the wrist and fingers.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Third degree brns to one or both hands

• All areas closed

• Age between 5 and 18 years old

• English or Spanish speaking

Exclusion Criteria:

• Previous hand condition

• Unable to follow 2 step directions

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Burns

Intervention

Behavioral:
• Functional hand tests
Chilren were tested after healed hand burns for functional ability.

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children - Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blocks & Box (Standardized Test).	Children are asked to move as many blocks as possible from one box to another in one minute. The number of blocks moved is the score.	Baseline	No
Primary	Range of Motion, Total Active Motion (TAM)	Subjects' degrees of hand motion are measured by a trained therapist and recorded. Total Active Motion is a measure of finger range of motion that can be used to predict functional movement of the hand. The TAM is the sum of the degrees of active motion of each of the three joints of the fingers, and two joints of the thumb. For this study we also included wrist motion. Full TAM is 1,455 degrees of motion.	Baseline	No
Primary	Grip Strength	This is a measure of grip strength in pounds using a dynamometer. The subject squeezes the dynamometer as hard as possible for three trials separated by a short rest. The mean of the three trials is the score.	Baseline	No
Primary	Moberg Pickup Test	The child picks up 12 small objects such as a coin, safety pin and paper clip one at a time and puts them in a container. The time in seconds to complete the task is the score.	Seconds to pick up all 12 objects	No