- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00363675
Evaluation of Hand Assessments in Children With Severe Hand Burns
February 29, 2012 updated by: Mary Jo Baryza, Massachusetts General Hospital
This study is designed to see if some tests of hand movement, strength, and function are valid for children with burns.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Shriners Hospitals for Children - Boston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: All study participants
Children with hand burns
|
Chilren were tested after healed hand burns for functional ability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blocks & Box (Standardized Test).
Time Frame: Baseline
|
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
|
Range of Motion, Total Active Motion (TAM)
Time Frame: Baseline
|
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
|
Grip Strength
Time Frame: Baseline
|
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
|
Moberg Pickup Test
Time Frame: Seconds to pick up all 12 objects
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary Jo Baryza, MS, PT, PCS, Shriners Hospitals for Children - Boston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
August 9, 2006
First Submitted That Met QC Criteria
August 9, 2006
First Posted (Estimate)
August 15, 2006
Study Record Updates
Last Update Posted (Estimate)
March 28, 2012
Last Update Submitted That Met QC Criteria
February 29, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-P000388/3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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