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

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

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.

Study Overview

• Status: Completed
• Conditions: Hand Injuries; Edema Arm
• Intervention / Treatment: Other: Figure-of-eight tape measure measurements on both hands; Other: Volumeter measurements

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.

• Study Type: Observational
• Enrollment (Actual): 59

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uninjured hands; healthy participants without injuries to hands or wrists	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.; Other: Volumeter measurements; Volumeter measurements to uninjured participants had 3 measurements taken of each hand.
Injured hands; participants undergoing medical treatment for recent hand or wrist injury	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Figure-of-Eight non-injured hands	3 measurements of right and left hands of each non-injured participant by 3 hand therapists	1 day
Volumetric measurements on non-injured hands	3 measurements of right and left hands of each non-injured participant	1 day
Figure-of-Eight injured hands	3 measurements of right and left hands of each non-injured participant by 3 different hand therapists	1 day

Collaborators and Investigators

• Sponsor: University of Massachusetts, Lowell

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2011
• Primary Completion (Actual): April 30, 2014
• Study Completion (Actual): April 30, 2014

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 29, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: edema; physical therapy; occupational therapy; reliability; figure-of-eight
• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries
• Other Study ID Numbers: 11-056-LEW-XPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not planning to share the de-identified data on this population

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No