Back to resultsEvaluation of Hand Assessments in Children With Severe Hand Burns
Primary Purpose
Burns
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional hand tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Burns focused on measuring Hand Burns, Pediatrics
Eligibility Criteria
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
Sites / Locations
- Shriners Hospitals for Children - Boston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All study participants
Arm Description
Children with hand burns
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00363675
First Posted
August 9, 2006
Last Updated
February 29, 2012
Sponsor
Massachusetts General Hospital
Collaborators
Shriners Hospitals for Children
1. Study Identification
Unique Protocol Identification Number
NCT00363675
Brief Title
Evaluation of Hand Assessments in Children With Severe Hand Burns
Official Title
Evaluation of Hand Assessments in Children With Severe Hand Burns
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
This was a pilot study, but the larger study was not funded.
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Shriners Hospitals for Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to see if some tests of hand movement, strength, and function are valid for children with burns.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Hand Burns, Pediatrics
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All study participants
Arm Type
Experimental
Arm Description
Children with hand burns
Intervention Type
Behavioral
Intervention Name(s)
Functional hand tests
Intervention Description
Chilren were tested after healed hand burns for functional ability.
Primary Outcome Measure Information:
Title
Blocks & Box (Standardized Test).
Description
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.
Time Frame
Baseline
Title
Range of Motion, Total Active Motion (TAM)
Description
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.
Time Frame
Baseline
Title
Grip Strength
Description
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.
Time Frame
Baseline
Title
Moberg Pickup Test
Description
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.
Time Frame
Seconds to pick up all 12 objects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jo Baryza, MS, PT, PCS
Organizational Affiliation
Shriners Hospitals for Children - Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children - Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Hand Assessments in Children With Severe Hand Burns
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