Clinical Trials Directory

Trials / Completed

CompletedNCT02889705

Echotexture in Following Muscle Fibrosis

Longitudinal Follow-up of Muscle Echotextures in Infants With Congenital Muscular Torticollis

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Chang Gung Memorial Hospital · Academic / Other
Sex
All
Age
1 Month – 12 Months
Healthy volunteers
Not accepted

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. 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

1. 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. 2. 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

Interventions

TypeNameDescription
OTHERUltrasonographic examination

Timeline

Start date
2012-08-01
Primary completion
2015-07-01
First posted
2016-09-05
Last updated
2016-09-05

Source: ClinicalTrials.gov record NCT02889705. Inclusion in this directory is not an endorsement.

Echotexture in Following Muscle Fibrosis (NCT02889705) · Clinical Trials Directory