NCT00363675

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 28, 2012

Completed
Last Updated

March 28, 2012

Status Verified

February 1, 2012

Enrollment Period

5 years

First QC Date

August 9, 2006

Results QC Date

February 29, 2012

Last Update Submit

February 29, 2012

Conditions

Keywords

Hand BurnsPediatrics

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

All study participants

EXPERIMENTAL

Children with hand burns

Behavioral: Functional hand tests

Interventions

Chilren were tested after healed hand burns for functional ability.

All study participants

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Third degree brns to one or both hands
  • All areas closed
  • Age between 5 and 18 years old
  • English or Spanish speaking

You may not qualify if:

  • Previous hand condition
  • Unable to follow 2 step directions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children - Boston

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

This pilot study was discontinued secondary to lack of grant funding for the project.

Results Point of Contact

Title
Mary Jo Baryza, Diredtor of Therapeutic Services
Organization
Shrines Hospitals for Children - Boston

Study Officials

  • Mary Jo Baryza, MS, PT, PCS

    Shriners Hospitals for Children - Boston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Therapeutic Services, Shriners Hospitals for Children

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 28, 2012

Results First Posted

March 28, 2012

Record last verified: 2012-02

Locations