Echotexture in Following Muscle Fibrosis

NCT02889705 | Completed

• 1 other identifier: 100-4436B
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Congenital Muscular Torticollis

Keywords

Ultrasonography; echotexture; K value; SCM muscles; CMT infants

Outcome Measures

Primary Outcomes (7)

• K value

  Difference of echo intensities on muscle sonograms between involved and uninvolved sternocleidomastoid muscles in 50 infants with congenital muscular torticollis

  3 years

• Muscle thickness in cm

  Bilateral sternocleidomastoid muscle thickness in 50 infants with congenital muscular torticollis

  3 years

• Ratio I/U (involved-to-uninvolved muscle thickness ratio)

  3 years

• Age in month

  The age of first evaluation

  3 years

• Times of ultrasonographic examinations

  The times of ultrasonographic examination before end follow-up

  3 years

• Body weight in kg

  Body weight of all subjects during the follow-up period

  3 years

• Body length in cm

  Body length of all subjects during the follow-up period

  3 years

Interventions

Ultrasonographic examination OTHER

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Subjects with neurological symptoms or signs
• Cervical spine abnormalities
• Developmental dysplastic hip problems

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Congenital torticollis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 5, 2016
• Study Start: August 1, 2012
• Primary Completion: July 1, 2015
• Last Updated: September 5, 2016

Record last verified: 2016-08