Evaluation of Hand Assessments in Children With Severe Hand Burns

This study has been terminated.
(This was a pilot study, but the larger study was not funded.)
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
Mary Jo Baryza, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00363675
First received: August 9, 2006
Last updated: February 29, 2012
Last verified: February 2012
Results First Received: February 29, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Burns
Intervention: Behavioral: Functional hand tests

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Study Participants Children were administered hand assessments to measure function after hand burns by a trained therapist.

Participant Flow:   Overall Study
    All Study Participants  
STARTED     3  
Completed Testing     3  
COMPLETED     3  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants Children were administered hand assessments to measure function after hand burns by a trained therapist.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     3  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures
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1.  Primary:   Blocks & Box (Standardized Test).   [ Time Frame: Baseline ]

2.  Primary:   Range of Motion, Total Active Motion (TAM)   [ Time Frame: Baseline ]

3.  Primary:   Grip Strength   [ Time Frame: Baseline ]

4.  Primary:   Moberg Pickup Test   [ Time Frame: Seconds to pick up all 12 objects ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This pilot study was discontinued secondary to lack of grant funding for the project.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mary Jo Baryza, Diredtor of Therapeutic Services
Organization: Shrines Hospitals for Children - Boston
phone: 617-371-4749
e-mail: mbaryza@shrinenet.org


No publications provided


Responsible Party: Mary Jo Baryza, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00363675     History of Changes
Other Study ID Numbers: 2006-P000388/3
Study First Received: August 9, 2006
Results First Received: February 29, 2012
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board