Clinical trial NCT00137228: Measuring Hand Edema in Burn Patients
Official title: The Reliability and Concurrent Validity of the Figure-of-Eight Method of Measuring Hand Edema in Patients With Burn Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema
Keywords: Hand Edema
Figure of eight method
Measuring edema in burn patients
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2005-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the reliability and concurrent validity of the figure-of-eight method of measuring hand edema in the burn patient population. Establishing the reliability and validity would enable a more time efficient assessment than the currently accepted methods.

Detailed description: A prospective study involving 33 burn patients admitted to the US Army Burn Center. Two raters will perform three separate blinded measurements for hand edema using the figure-of-eight measurement technique. A third rater will then perform two blinded measurements using water volumetry. All measurements will be read and recorded by an independent recorder. The three measurements of rater 1 and 2 will be analyzed to determine intratester reliability. The average of the three figure-of-eight measurements will be compared to measure intertester reliability. The two volumetry measurements will be compared to determine intratester reliability. The average of the 2 volumetry measurements and the average fo the three figure-of-eight measurements will be used to determine concurrent validity.

Eligibility criteria: Inclusion Criteria:

* Male or female 18-89 years old
* Admitted to the United States (U.S.) Army Burn Intensive Care Unit (ICU) or ward with burn injury and the presence of bilateral or unilateral hand edema

Exclusion Criteria:

* Subject unable to be placed in test position for volumetry testing or the presence of a medical condition, as defined by a physician, that precludes the safe use of volumetry.
* Subject is unable to tolerate his/her hand(s) being immersed in room temperature water for volumetry testing.
* Subject does not have any of the bony landmarks (due to amputation, previous surgery) required to perform the figure-of-eight measurement

Primary outcomes:
measure: The figure-of-eight method for measuring hand edema in burn patients is just as reliable and valid as water volumetry measurement.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: U.S. Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: US Army Institute of Surgical Research
name: Scott Dewey, PT, CHT, OCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leard JS, Breglio L, Fraga L, Ellrod N, Nadler L, Yasso M, Fay E, Ryan K, Pellecchia GL. Reliability and concurrent validity of the figure-of-eight method of measuring hand size in patients with hand pathology. J Orthop Sports Phys Ther. 2004 Jun;34(6):335-40. doi: 10.2519/jospt.2004.34.6.335.