Contractures Resulting From Burn Scar TissueNCT01034813
Joint Range of Motion in Burn Scars
An observational study of Contractures Resulting From Burn Scar Tissue, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
The purpose of this study is to determine the relationship between cutaneous functional unit(CFU)recruitment throughout the available active range of motion of a prescribed joint in normal subjects and patients with burn scars. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Contractures Resulting From Burn Scar Tissue
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 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: Military and civilian burn patients.Control population will be individuals without upper extremity injury.
Who may be able to join
- Inclusion Criteria include: 1) male or female burn survivors between the ages of 18 and 60, 2) an area of scar covering at least fifty percent of the CFU of interest, 3) control subjects must have full active range of motion of the metacarpal phalangeal joints, wrist and elbow according to published normative references and be free of any history neuromusculoskeletal injury within the last three years that involved the joints of interest.
Who cannot join
- Exclusion Criteria include: 1)burn survivors with an area of scar of less than fifty percent of the CFU of interest, 2) burn survivors with a history of orthopedic trauma to the upper extremity (i.e. sprain within the last 24 months, history of fracture, or history of joint dislocation), 3) control subjects with a history of upper extremity trauma or injury, 4) control subjects with the presence of scar tissue covering an area of more than one percent of the CFU of interest, 5) any potential subject with a history or rheumatoid arthritis, osteoarthritis affecting the extremity of interest, peripheral nerve injury of the extremity of interest, or systemic disorder affecting joint range of motion of the upper extremity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Joint Range of Motion and Cutaneous Functional Unit Recruitment: Association With Burn Scar Characteristics
The purpose of this study is to determine the relationship between cutaneous functional unit(CFU)recruitment throughout the available active range of motion of a prescribed joint in normal subjects and patients with burn scars. Specifically, this study will determine if differences in CFU recruitment exist between normal subjects and individuals with burn scars at the dorsal hand, dorsal or volar forearm, or anterior or posterior arm during active range of motion of the MCP joint during flexion, or the wrist or elbow during flexion or extension, respectively.
Read the detailed description
Specific Aim #1: To establish the relationship between joint position and skin recruitment, expressed as the percentage of CFU recruited during active ROM, in patients with burn scars and normal controls.
Specific Aim #2: To establish the within-day and between-day reliability of percent CFU estimation and absolute skin recruitment, measured in millimeters from a fixed reference, during active ROM for a specified joint.
Specific Aim #3: To establish the relationship between scar height, measured by diagnostic ultrasound, scar cross-sectional area, and percent CFU recruitment in individuals with burn scar.
Specific Aim #4: To determine whether the amount of skin recruitment, expressed as the percent of the CFU recruited during active ROM, is differentially affected by burn scar.
Ho: There is no difference in the percent CFU recruited at the completion of active range of motion at a specified joint between individuals with burn scars and normal controls.
Ha: Individuals with burn scars recruit a greater percentage of the CFU in order to obtain maximal range of motion at a specified joint.
Specific Aim #5: To determine whether the timing of skin recruitment, expressed as the initiation of skin movement within a CFU relative to joint position during active ROM, is differentially affected by burn scar.
Ho: There is no difference in the initiation of skin movement within a CFU relative to joint position during active ROM at a specified joint between individuals with burn scars and normal controls.
Ha: In individuals with burn scars in a given CFU, skin movement farther from the joint axis occurs earlier in the range of motion compared to controls.
Specific Aim #6: To determine whether skin extensibility within a CFU during active ROM of a specified joint is differentially affected by burn scar.
Ho: There is no difference skin extensibility within a CFU during active ROM of a specified joint between individuals with burn scars and normal controls.
Ha: In individuals with burn scars in a given CFU, skin near the joint axis undergoes greater deformation (stretch) as range of motion at the joint increases compared to controls.
- Keywords
- contractures, range of motion, scar formation
- Medical subject headings
- Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Burn Range of motion | burn patients with hypertropic scar | |
| control range of motion | control subjects without scaring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Measured: 3-5 days
Secondary outcomes (1)
Scar Hypertrophy
Measured: 3--5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startMar 2010
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: New PI discovered that some of previously collected data may not be accurate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contractures Resulting From Burn Scar TissueStudies 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
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William S Dewey, PT, CHT, Principal investigator, United States Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034813
- Sponsor's protocol ID
- H-09-039
- Status last verified
- Feb 2015
- First submitted
- 16 Dec 2009
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nedelec B, Correa JA, Rachelska G, Armour A, LaSalle L. Quantitative measurement of hypertrophic scar: interrater reliability and concurrent validity. J Burn Care Res. 2008 May-Jun;29(3):501-11. doi: 10.1097/BCR.0b013e3181710881.
PubMed 18388576
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Joint Range of Motion and Cutaneous Functional Unit Recruitment: Association With Burn Scar Characteristics
- ClinicalTrials.gov ID
- NCT01034813
- Acronym / sponsor ID
- H-09-039
- Keywords
- contractures, range of motion, scar formation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: New PI discovered that some of previously collected data may not be accurate
- Enrolment
- 43 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Mar 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Dec 2009 (estimated)
- 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.
The purpose of this study is to determine the relationship between cutaneous functional unit(CFU)recruitment throughout the available active range of motion of a prescribed joint in normal subjects and patients with burn scars. Specifically, this study will determine if differences in CFU recruitment exist between normal subjects and individuals with burn scars at the dorsal hand, dorsal or volar forearm, or anterior or posterior arm during active range of motion of the MCP joint during flexion, or the wrist or elbow during flexion or extension, respectively.
Detailed description
Specific Aim #1: To establish the relationship between joint position and skin recruitment, expressed as the percentage of CFU recruited during active ROM, in patients with burn scars and normal controls.
Specific Aim #2: To establish the within-day and between-day reliability of percent CFU estimation and absolute skin recruitment, measured in millimeters from a fixed reference, during active ROM for a specified joint.
Specific Aim #3: To establish the relationship between scar height, measured by diagnostic ultrasound, scar cross-sectional area, and percent CFU recruitment in individuals with burn scar.
Specific Aim #4: To determine whether the amount of skin recruitment, expressed as the percent of the CFU recruited during active ROM, is differentially affected by burn scar.
Ho: There is no difference in the percent CFU recruited at the completion of active range of motion at a specified joint between individuals with burn scars and normal controls.
Ha: Individuals with burn scars recruit a greater percentage of the CFU in order to obtain maximal range of motion at a specified joint.
Specific Aim #5: To determine whether the timing of skin recruitment, expressed as the initiation of skin movement within a CFU relative to joint position during active ROM, is differentially affected by burn scar.
Ho: There is no difference in the initiation of skin movement within a CFU relative to joint position during active ROM at a specified joint between individuals with burn scars and normal controls.
Ha: In individuals with burn scars in a given CFU, skin movement farther from the joint axis occurs earlier in the range of motion compared to controls.
Specific Aim #6: To determine whether skin extensibility within a CFU during active ROM of a specified joint is differentially affected by burn scar.
Ho: There is no difference skin extensibility within a CFU during active ROM of a specified joint between individuals with burn scars and normal controls.
Ha: In individuals with burn scars in a given CFU, skin near the joint axis undergoes greater deformation (stretch) as range of motion at the joint increases compared to controls.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burn Range of motion | – | –burn patients with hypertropic scar |
| control range of motion | – | –control subjects without scaring |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Military and civilian burn patients.Control population will be individuals without upper extremity injury.
Key inclusion criteria (1 listed)
- Inclusion Criteria include: 1) male or female burn survivors between the ages of 18 and 60, 2) an area of scar covering at least fifty percent of the CFU of interest, 3) control subjects must have full active range of motion of the metacarpal phalangeal joints, wrist and elbow according to published normative references and be free of any history neuromusculoskeletal injury within the last three years that involved the joints of interest.
Key exclusion criteria (1 listed)
- Exclusion Criteria include: 1)burn survivors with an area of scar of less than fifty percent of the CFU of interest, 2) burn survivors with a history of orthopedic trauma to the upper extremity (i.e. sprain within the last 24 months, history of fracture, or history of joint dislocation), 3) control subjects with a history of upper extremity trauma or injury, 4) control subjects with the presence of scar tissue covering an area of more than one percent of the CFU of interest, 5) any potential subject with a history or rheumatoid arthritis, osteoarthritis affecting the extremity of interest, peripheral nerve injury of the extremity of interest, or systemic disorder affecting joint range of motion of the upper extremity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Range of motion
Time frame: 3-5 days
1 secondary outcome
Scar Hypertrophy
Time frame: 3--5 days
Results and safety
The study was stopped early (reason given: New PI discovered that some of previously collected data may not be accurate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Background: PubMed 18388576Nedelec B, Correa JA, Rachelska G, Armour A, LaSalle L. Quantitative measurement of hypertrophic scar: interrater reliability and concurrent validity. J Burn Care Res. 2008 May-Jun;29(3):501-11. doi: 10.1097/BCR.0b013e3181710881.
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.
William S Dewey, PT, CHT principal investigator
United States Army Institute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contractures Resulting From Burn Scar Tissue, run by United States Army Institute of Surgical Research 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 1 inclusion and 1 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 4 Feb 2015. 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?
The study was stopped early (reason given: New PI discovered that some of previously collected data may not be accurate). Results are not available in the source record.
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?
Range of motion (time frame: 3-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034813, which also lists 1 linked publication.
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 4 Feb 2015.