BurnsNCT00363675
Evaluation of Hand Assessments in Children With Severe Hand Burns
A study testing Functional hand tests in people with Burns, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is designed to see if some tests of hand movement, strength, and function are valid for children with burns. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Burns
- What is being tested?
- Functional hand tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Third degree brns to one or both hands
- All areas closed
- Age between 5 and 18 years old
- English or Spanish speaking
Who cannot join
- Previous hand condition
- Unable to follow 2 step directions
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children - Boston
Boston, Massachusetts, 02114
About this study
This study is designed to see if some tests of hand movement, strength, and function are valid for children with burns.
Read the detailed description
Children will be given a battery of tests to determine the validity of these measures for children with severe hand burns. The tests include:
- Pinch and grip strength;
- Stereognosis;
- Speed of manipulation using the Nine Hole Peg Test, Box \& Blocks Test, and the Moberg Pickup Test;
- Measurement of Range of Motion of the wrist and fingers.
- Conditions
- Burns
- Being tested
- Functional hand tests
- Keywords
- Hand Burns, Pediatrics
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional hand testsBehavioural
Chilren were tested after healed hand burns for functional ability.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Experimental | Children with hand burns Receives: Behavioral: Functional hand tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blocks & Box (Standardized Test).
Children are asked to move as many blocks as possible from one box to another in one minute. The number of blocks moved is the score.
Measured: Baseline
Range of Motion, Total Active Motion (TAM)
Subjects' degrees of hand motion are measured by a trained therapist and recorded. Total Active Motion is a measure of finger range of motion that can be used to predict functional movement of the hand. The TAM is the sum of the degrees of active motion of each of the three joints of the fingers, and two joints of the thumb. For this study we also included wrist motion. Full TAM is 1,455 degrees of motion.
Measured: Baseline
Grip Strength
This is a measure of grip strength in pounds using a dynamometer. The subject squeezes the dynamometer as hard as possible for three trials separated by a short rest. The mean of the three trials is the score.
Measured: Baseline
Moberg Pickup Test
The child picks up 12 small objects such as a coin, safety pin and paper clip one at a time and puts them in a container. The time in seconds to complete the task is the score.
Measured: Seconds to pick up all 12 objects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: This was a pilot study, but the larger study was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Principal investigator, Mary Jo Baryza, Massachusetts General Hospital
- Investigators
- Mary Jo Baryza, MS, PT, PCS, Principal investigator, Shriners Hospitals for Children - Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363675
- Sponsor's protocol ID
- 2006-P000388/3
- Status last verified
- Feb 2012
- First submitted
- 9 Aug 2006
- Last updated
- 28 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hand Assessments in Children With Severe Hand Burns
- ClinicalTrials.gov ID
- NCT00363675
- Acronym / sponsor ID
- 2006-P000388/3
- Conditions
- Burns
- Keywords
- Hand Burns, Pediatrics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was a pilot study, but the larger study was not funded.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- Aug 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 28 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to see if some tests of hand movement, strength, and function are valid for children with burns.
Detailed description
Children will be given a battery of tests to determine the validity of these measures for children with severe hand burns. The tests include:
- Pinch and grip strength;
- Stereognosis;
- Speed of manipulation using the Nine Hole Peg Test, Box \& Blocks Test, and the Moberg Pickup Test;
- Measurement of Range of Motion of the wrist and fingers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | Experimental | Behavioral: Functional hand testsChildren with hand burns |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Third degree brns to one or both hands
- All areas closed
- Age between 5 and 18 years old
- English or Spanish speaking
Key exclusion criteria (2 listed)
- Previous hand condition
- Unable to follow 2 step directions
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 |
|---|---|---|
| Functional hand testsChilren were tested after healed hand burns for functional ability. | Behavioural | All study participants |
Primary outcome
Blocks & Box (Standardized Test).
Time frame: Baseline
Children are asked to move as many blocks as possible from one box to another in one minute. The number of blocks moved is the score.
Range of Motion, Total Active Motion (TAM)
Time frame: Baseline
Subjects' degrees of hand motion are measured by a trained therapist and recorded. Total Active Motion is a measure of finger range of motion that can be used to predict functional movement of the hand. The TAM is the sum of the degrees of active motion of each of the three joints of the fingers, and two joints of the thumb. For this study we also included wrist motion. Full TAM is 1,455 degrees of motion.
Grip Strength
Time frame: Baseline
This is a measure of grip strength in pounds using a dynamometer. The subject squeezes the dynamometer as hard as possible for three trials separated by a short rest. The mean of the three trials is the score.
Moberg Pickup Test
Time frame: Seconds to pick up all 12 objects
The child picks up 12 small objects such as a coin, safety pin and paper clip one at a time and puts them in a container. The time in seconds to complete the task is the score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mary Jo Baryza, MS, PT, PCS principal investigator
Shriners Hospitals for Children - Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional hand tests in people with Burns, run by Massachusetts General Hospital at 1 site in United States.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 28 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blocks & Box (Standardized Test). (time frame: Baseline). The study lists 4 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 28 Mar 2012.