NCT03837951

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2014

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

February 8, 2019

Last Update Submit

March 29, 2020

Conditions

Keywords

reliabilityedemaphysical therapyoccupational therapyfigure-of-eight

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Uninjured hands

healthy participants without injuries to hands or wrists

Other: Figure-of-eight tape measure measurements on both handsOther: Volumeter measurements

Injured hands

participants undergoing medical treatment for recent hand or wrist injury

Other: Figure-of-eight tape measure measurements on both hands

Interventions

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

Injured handsUninjured hands

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

Uninjured hands

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hand InjuriesEdema

Condition Hierarchy (Ancestors)

Wounds and InjuriesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erika S. LEWIS, Ed.D

    Associate Professor, University of Massachusetts Lowell

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Interim DPT Program Director

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 12, 2019

Study Start

April 28, 2011

Primary Completion

April 30, 2014

Study Completion

April 30, 2014

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Not planning to share the de-identified data on this population