Trial Outcomes & Findings for Evaluation of Hand Assessments in Children With Severe Hand Burns (NCT NCT00363675)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

Baseline

Results posted on

2012-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants Children were administered hand assessments to measure function after hand burns by a trained therapist.
Overall Study STARTED	3
Overall Study Completed Testing	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Hand Assessments in Children With Severe Hand Burns

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=3 Participants Children were administered hand assessments to measure function after hand burns by a trained therapist.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Convenience sample was planned for this study.

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=3 Participants Children were administered hand assessments to measure function after hand burns by a trained therapist.
Blocks & Box (Standardized Test).	32 Blocks Interval 21.0 to 37.0

PRIMARY outcome

Timeframe: Baseline

Population: Convenience sample was planned for ths study.

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=3 Participants Children were administered hand assessments to measure function after hand burns by a trained therapist.
Range of Motion, Total Active Motion (TAM)	998 Degrees Interval 901.0 to 1260.0

PRIMARY outcome

Timeframe: Baseline

Population: Convenience sample was planned for this study.

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=3 Participants Children were administered hand assessments to measure function after hand burns by a trained therapist.
Grip Strength	7.33 Pounds Interval 4.0 to 9.17

PRIMARY outcome

Timeframe: Seconds to pick up all 12 objects

Population: A convenience sample was planned for this study.

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.

Outcome measures

Outcome measures
Measure	All Study Participants n=3 Participants Children were administered hand assessments to measure function after hand burns by a trained therapist.
Moberg Pickup Test	19 Seconds Interval 16.0 to 48.0

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary Jo Baryza, Diredtor of Therapeutic Services

Shrines Hospitals for Children - Boston

Phone: 617-371-4749

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place