Congenital Muscular TorticollisNCT02889705
Echotexture in Following Muscle Fibrosis
An observational study of Congenital Muscular Torticollis, run by Chang Gung Memorial Hospital.
Trial summary
Objective: To document the sternocleidomastoid (SCM) muscle fibrosis in congenital muscular torticollis (CMT) infants with quantified echotexture and measured thickness during the treatment course. Design: Cohort study. Setting: Rehabilitation department in a tertiary care hospital. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Congenital Muscular Torticollis
- What is being tested?
- Ultrasonographic examination
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jul 2015
- 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Convenience sample of infants in both gender with congenital muscular torticollis, are reviewed by the exclusion criteria (please see below). Subjects, whose parents are willing to sign the informed consent and fit our inclusion/exclusion criteria are prospectively enrolled in this study. Age, gender distribution, body weight (BW), body length (BL), affected muscle side, follow-up period, and interval between two visits were also recorded. Physiotherapy of passive stretching of the involved muscle, positioning, and massage were capable of diminishing the development of scoliosis and facial asymmetry in the future.
Who may be able to join
- infants with congenital muscular torticollis Presenting clinical features of the CMT infants, including head tilt in the upright position, facial asymmetry, limited passive range of motion in neck rotation, palpable neck mass
Who cannot join
- Subjects with neurological symptoms or signs
- Cervical spine abnormalities
- Developmental dysplastic hip problems
About this study
Official title: Longitudinal Follow-up of Muscle Echotextures in Infants With Congenital Muscular Torticollis
Objective: To document the sternocleidomastoid (SCM) muscle fibrosis in congenital muscular torticollis (CMT) infants with quantified echotexture and measured thickness during the treatment course.
Design: Cohort study. Setting: Rehabilitation department in a tertiary care hospital. Participants: Infants with clinical diagnosis of CMT, without any neurological presentation, cervical spin abnormality, and developmental dysplastic hip problem, were recruited in the study.
Read more
Intervention: All subjects had physiotherapy for at least 3 months. They underwent at least two times of clinical assessment and ultrasonographic examination (1) for bilateral SCM muscles during the follow-up period.
End of follow-up: Subjects who still had prominent clinical presentations after physiotherapy for 6 months or were older than 1 year would receive surgery. Subsided presenting clinical features determined by the clinician was the other end-point of this investigation.
Main Outcome Measures: The K value, derived from the difference of echo intensities (2) between the involved and uninvolved SCM muscles on longitudinal sonograms, was used to represent the severity of muscle fibrosis in CMT infants. Bilateral SCM muscle thickness and involved-to-uninvolved thickness ratio (Ratio I/U) were also obtained from longitudinal sonograms. Clinical outcome was also recorded.
Read the detailed description
- An experienced sonographer performed ultrasonographic examination with the subject in the supine position and heads rotated contralaterally to the examination side. A 5-12 MHz linear-array ultrasound transducer was used to observe both longitudinal and transverse views of bilateral SCM muscles for each subject. The ultrasound system settings, including gain (86%), monitor dynamic range (70 dB), and depth (2 cm), were kept constant throughout the study.
- The echo intensity was determined by computer-assisted gray scale analysis and was calculated in MATLAB 2006b. The mean echo intensity of every pixel in the region of interest and the K value developed to compare sonograms between different individuals or between different times in the same subject were estimated as the previous study (PMID: 22215768)
- Conditions
- Congenital Muscular Torticollis
- Being tested
- Ultrasonographic examination
- Keywords
- Ultrasonography, echotexture, K value, SCM muscles, CMT infants
- Medical subject headings
- Congenital torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic examinationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
K value
Difference of echo intensities on muscle sonograms between involved and uninvolved sternocleidomastoid muscles in 50 infants with congenital muscular torticollis
Measured: 3 years
Muscle thickness in cm
Bilateral sternocleidomastoid muscle thickness in 50 infants with congenital muscular torticollis
Measured: 3 years
Ratio I/U (involved-to-uninvolved muscle thickness ratio)
Measured: 3 years
Age in month
The age of first evaluation
Measured: 3 years
Times of ultrasonographic examinations
The times of ultrasonographic examination before end follow-up
Measured: 3 years
Body weight in kg
Body weight of all subjects during the follow-up period
Measured: 3 years
Body length in cm
Body length of all subjects during the follow-up period
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startAug 2012
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Muscular TorticollisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Chin Hsu, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889705
- Sponsor's protocol ID
- 100-4436B
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow-up of Muscle Echotextures in Infants With Congenital Muscular Torticollis
- ClinicalTrials.gov ID
- NCT02889705
- Acronym / sponsor ID
- 100-4436B
- Conditions
- Congenital Muscular Torticollis
- Keywords
- Ultrasonography, echotexture, K value, SCM muscles, CMT infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2015 (actual)
- First posted
- 5 Sep 2016 (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.
Objective: To document the sternocleidomastoid (SCM) muscle fibrosis in congenital muscular torticollis (CMT) infants with quantified echotexture and measured thickness during the treatment course.
Design: Cohort study. Setting: Rehabilitation department in a tertiary care hospital. Participants: Infants with clinical diagnosis of CMT, without any neurological presentation, cervical spin abnormality, and developmental dysplastic hip problem, were recruited in the study.
Intervention: All subjects had physiotherapy for at least 3 months. They underwent at least two times of clinical assessment and ultrasonographic examination (1) for bilateral SCM muscles during the follow-up period.
End of follow-up: Subjects who still had prominent clinical presentations after physiotherapy for 6 months or were older than 1 year would receive surgery. Subsided presenting clinical features determined by the clinician was the other end-point of this investigation.
Main Outcome Measures: The K value, derived from the difference of echo intensities (2) between the involved and uninvolved SCM muscles on longitudinal sonograms, was used to represent the severity of muscle fibrosis in CMT infants. Bilateral SCM muscle thickness and involved-to-uninvolved thickness ratio (Ratio I/U) were also obtained from longitudinal sonograms. Clinical outcome was also recorded.
Detailed description
- An experienced sonographer performed ultrasonographic examination with the subject in the supine position and heads rotated contralaterally to the examination side. A 5-12 MHz linear-array ultrasound transducer was used to observe both longitudinal and transverse views of bilateral SCM muscles for each subject. The ultrasound system settings, including gain (86%), monitor dynamic range (70 dB), and depth (2 cm), were kept constant throughout the study.
- The echo intensity was determined by computer-assisted gray scale analysis and was calculated in MATLAB 2006b. The mean echo intensity of every pixel in the region of interest and the K value developed to compare sonograms between different individuals or between different times in the same subject were estimated as the previous study (PMID: 22215768)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Convenience sample of infants in both gender with congenital muscular torticollis, are reviewed by the exclusion criteria (please see below). Subjects, whose parents are willing to sign the informed consent and fit our inclusion/exclusion criteria are prospectively enrolled in this study. Age, gender distribution, body weight (BW), body length (BL), affected muscle side, follow-up period, and interval between two visits were also recorded. Physiotherapy of passive stretching of the involved muscle, positioning, and massage were capable of diminishing the development of scoliosis and facial asymmetry in the future.
Key inclusion criteria (1 listed)
- infants with congenital muscular torticollis Presenting clinical features of the CMT infants, including head tilt in the upright position, facial asymmetry, limited passive range of motion in neck rotation, palpable neck mass
Key exclusion criteria (3 listed)
- Subjects with neurological symptoms or signs
- Cervical spine abnormalities
- Developmental dysplastic hip problems
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 |
|---|---|---|
| Ultrasonographic examination | Other | – |
Primary outcome
K value
Time frame: 3 years
Difference of echo intensities on muscle sonograms between involved and uninvolved sternocleidomastoid muscles in 50 infants with congenital muscular torticollis
Muscle thickness in cm
Time frame: 3 years
Bilateral sternocleidomastoid muscle thickness in 50 infants with congenital muscular torticollis
Ratio I/U (involved-to-uninvolved muscle thickness ratio)
Time frame: 3 years
Age in month
Time frame: 3 years
The age of first evaluation
Times of ultrasonographic examinations
Time frame: 3 years
The times of ultrasonographic examination before end follow-up
Body weight in kg
Time frame: 3 years
Body weight of all subjects during the follow-up period
Body length in cm
Time frame: 3 years
Body length of all subjects during the follow-up period
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 5 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Muscular Torticollis, run by Chang Gung Memorial Hospital.
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 3 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 5 Sep 2016. 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?
K value (time frame: 3 years). The study lists 7 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 5 Sep 2016.