Clinical trial NCT03837951: Figure-of-Eight Hand, Volumetric Measurements and Reliability in Clinic With Hand Injured Patients
Official title: Comparison of Figure-of-Eight Hand Measurements to Standard Volumetric Measurements and Its Reliability Within a Clinical Setting With Hand Injured Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hand Injuries
Edema Arm
Keywords: reliability
edema
physical therapy
occupational therapy
figure-of-eight
Lead sponsor: University of Massachusetts, Lowell
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Part A: Thirty healthy participants (10 men and 20 women) were recruited from the student population at a university.

Part B: 17 participants with upper extremity injury (4 men \& 13 women)

Brief summary: This study determined the intra-rater and inter-rater reliability of the Figure-of-Eight method on healthy hands, and compared the figure-of-eight measurements to the gold standard volumetric measurements. Part B of the study conducted in a clinic, assessed the intra-rater reliability and inter-rater reliability on both hands of patients with hand injuries.

Detailed description: Edema is the retention of fluid in the intracellular spaces, which is common in inflammatory condition such as traumatic injury and post surgical conditions. Edema in the hand and wrist can result in detrimental physiological changes which decrease the range of motion of joint and limit the overall functional capacity and dexterity of the hand. The gold standard Volumetric measurements are reliable for measuring edema changes in upper extremity. Using volumeters can be cumbersome in a busy clinic. Figure-of-eight measurements using a tape measure on the wrist and hand is an easy way to measure edema and can capture the accumulation in the dorsal hand that circumferential tape measurements do not capture. This study was performed in two parts. Part A determined the intra-rater and inter-rater reliability of the Figure-of-Eight method on healthy hands, and compared the figure-of-eight measurements to the gold standard volumetric measurements. No study other study has compared right and left hands. Part B of the study was conducted in a clinic to assess the intra-rater reliability and inter-rater reliability on both hands of patients with hand injuries.

Eligibility criteria: Inclusion Criteria

* Healthy-part A
* Recent history of hand or wrist injury with swelling -part B

Exclusion Criteria

* Open wounds-part A
* Current swelling-part A
* History of injury in either upper extremity-part A
* Diabetes mellitus-part A
* Raynaud's Syndrome-part A
* Pregnant women-part A \& B
* Could not speak English-part A \& B
* Could not consent for oneself-part A \& B

Primary outcomes:
measure: Figure-of-Eight non-injured hands
timeFrame: 1 day
measure: Volumetric measurements on non-injured hands
timeFrame: 1 day
measure: Figure-of-Eight injured hands
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor, University of Massachusetts Lowell
name: Erika S. LEWIS, Ed.D
role: PRINCIPAL_INVESTIGATOR
References: