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NCT Number: NCT03837951

Figure-of-Eight Hand, Volumetric Measurements and Reliability in Clinic 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Figure-of-eight tape measure measurements on both hands

Other

Tape measure is wrapped around the wrist and hand and a measurement reading is taken. this is repeated 3 times.

Volumeter measurements

Other

Volumeter measurements to uninjured participants had 3 measurements taken of each hand.

Primary outcomes

  1. Figure-of-Eight non-injured hands

    Time frame: 1 day

    3 measurements of right and left hands of each non-injured participant by 3 hand therapists

  2. Volumetric measurements on non-injured hands

    Time frame: 1 day

    3 measurements of right and left hands of each non-injured participant

  3. Figure-of-Eight injured hands

    Time frame: 1 day

    3 measurements of right and left hands of each non-injured participant by 3 different hand therapists

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Lowell

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2019
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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