Figure-of-Eight Hand, Volumetric Measurements and Reliability in Clinic With Hand Injured Patients

Hand Injuries Clinical Trial

Official title:

Comparison of Figure-of-Eight Hand Measurements to Standard Volumetric Measurements and Its Reliability Within a Clinical Setting With Hand Injured Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837951
• Other study ID #: 11-056-LEW-XPD
• Status: Completed
• Start date: April 28, 2011
• Est. completion date: April 30, 2014

Study information

• Verified date: March 2020
• Source: University of Massachusetts, Lowell
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 30, 2014
• Est. primary completion date: April 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Edema Arm
• Hand Injuries

Intervention

Other:
• Figure-of-eight tape measure measurements on both hands
Tape measure is wrapped around the wrist and hand and a measurement reading is taken. this is repeated 3 times.
• Volumeter measurements
Volumeter measurements to uninjured participants had 3 measurements taken of each hand.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Lowell

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Figure-of-Eight non-injured hands	3 measurements of right and left hands of each non-injured participant by 3 hand therapists	1 day
Primary	Volumetric measurements on non-injured hands	3 measurements of right and left hands of each non-injured participant	1 day
Primary	Figure-of-Eight injured hands	3 measurements of right and left hands of each non-injured participant by 3 different hand therapists	1 day