Hand InjuriesNCT03837951
Figure-of-Eight Hand, Volumetric Measurements and Reliability in Clinic With Hand Injured Patients
An observational study of Hand Injuries and Edema Arm, run by University of Massachusetts, Lowell.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries, Edema Arm
- What is being tested?
- Figure-of-eight tape measure measurements on both hands and Volumeter measurements
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2011to 30 Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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)
Who may be able to join
- Healthy-part A
- Recent history of hand or wrist injury with swelling -part B
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Hand Injuries, Edema Arm
- Being tested
- Figure-of-eight tape measure measurements on both hands, Volumeter measurements
- Keywords
- reliability, edema, physical therapy, occupational therapy, figure-of-eight
- Medical subject headings
- Hand Injuries, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Figure-of-eight tape measure measurements on both handsOther
Tape measure is wrapped around the wrist and hand and a measurement reading is taken. this is repeated 3 times.
Volumeter measurementsOther
Volumeter measurements to uninjured participants had 3 measurements taken of each hand.
| Study group | Role | What they receive |
|---|---|---|
| Uninjured hands | healthy participants without injuries to hands or wrists Receives: Other: Figure-of-eight tape measure measurements on both hands; Other: Volumeter measurements | |
| Injured hands | participants undergoing medical treatment for recent hand or wrist injury Receives: Other: Figure-of-eight tape measure measurements on both hands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Figure-of-Eight non-injured hands
3 measurements of right and left hands of each non-injured participant by 3 hand therapists
Measured: 1 day
Volumetric measurements on non-injured hands
3 measurements of right and left hands of each non-injured participant
Measured: 1 day
Figure-of-Eight injured hands
3 measurements of right and left hands of each non-injured participant by 3 different hand therapists
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start28 Apr 2011
- Primary completion30 Apr 2014
- Study completion30 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Lowell
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ELewis, University of Massachusetts, Lowell
- Investigators
- Erika S. LEWIS, Ed.D, Principal investigator, Associate Professor, University of Massachusetts Lowell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837951
- Sponsor's protocol ID
- 11-056-LEW-XPD
- Status last verified
- Mar 2020
- First submitted
- 8 Feb 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planning to share the de-identified data on this population
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Figure-of-Eight Hand Measurements to Standard Volumetric Measurements and Its Reliability Within a Clinical Setting With Hand Injured Patients
- ClinicalTrials.gov ID
- NCT03837951
- Acronym / sponsor ID
- 11-056-LEW-XPD
- Conditions
- Hand Injuries, Edema Arm
- Keywords
- reliability, edema, physical therapy, occupational therapy, figure-of-eight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Massachusetts, LowellUniversity, hospital or other
- Study start
- 28 Apr 2011 (actual)
- Primary completion
- 30 Apr 2014 (actual)
- Study completion
- 30 Apr 2014 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uninjured hands | – | Other: Figure-of-eight tape measure measurements on both hands, Other: Volumeter measurementshealthy participants without injuries to hands or wrists |
| Injured hands | – | Other: Figure-of-eight tape measure measurements on both handsparticipants undergoing medical treatment for recent hand or wrist injury |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (2 listed)
- Healthy-part A
- Recent history of hand or wrist injury with swelling -part B
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Figure-of-eight tape measure measurements on both handsTape measure is wrapped around the wrist and hand and a measurement reading is taken. this is repeated 3 times. | Other | Injured hands, Uninjured hands |
| Volumeter measurementsVolumeter measurements to uninjured participants had 3 measurements taken of each hand. | Other | Uninjured hands |
Primary outcome
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
Volumetric measurements on non-injured hands
Time frame: 1 day
3 measurements of right and left hands of each non-injured participant
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: No. Not planning to share the de-identified data on this population
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika S. LEWIS, Ed.D principal investigator
Associate Professor, University of Massachusetts Lowell
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Injuries and Edema Arm, run by University of Massachusetts, Lowell.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Figure-of-Eight non-injured hands (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.