Investigating the Effectiveness of Mobilization on Congenital Muscular Torticollis and Deformational Plagiocephaly

NCT ID: NCT02403011

Last Updated: 2015-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-11-30

Brief Summary

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This study investigates the effect of soft tissue mobilization in babies with neck muscle problem. Babies received soft tissue mobilization or home exercises program

Detailed Description

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Objectives: Investigating the effectiveness of soft tissue mobilization in babies with congenital muscular torticollis and deformational plagiocephaly.

Design: A Randomized controlled trial design Setting: University research department Participants:Babies with congenital muscular torticollis, aged between 0-6 months, who had a head tilt from 5 to 20 degrees and no other health problems were the participants of the study. The study included two groups; home program group was seen once every six weeks, the study group in addition to the home program also received soft tissue mobilization three times in a week. All groups received a baseline home program consisting of positioning, handling strategies plus stretching, stretching and strengthening exercises, environmental adaptations and classical massage. Babies were allocated to two groups by sealed envelope randomization. Babies were evaluated initially, at sixth weeks, at 12 weeks and follow-up at 18 weeks with muscle function scale, head tilt and ear shift assessments which included photographing method, neck normal range of motions (lateral flexion and rotation) and plagiocephaly severity scale

Conditions

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Congenital Muscular Torticollis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Soft tissue mobilization group

soft tissue mobilization was applied three times in a week and home program exercises were recommended which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations

Group Type EXPERIMENTAL

soft tissue mobilization

Intervention Type OTHER

soft tissue mobilization technique has three phases. First phase 'the passive mobilization phase' is applied by gentle but tight gripping of the SKM muscle two or three fingers below the muscle origo and the muscle is mobilized rhythmically in the antero-posterior direction. Secondly, after gently continue to hold the muscle the baby was encouraged to do active repetitive cervical rotation to the affected side by means of catching the babies attention with colored and sonorous toys. Third phase was mobilization with stretching. Caregiver holds the baby on his/ her affected side while the therapist gently grips and withholds the muscle. Therapist mobilizes the muscle in the antero-posterior direction and stretch the muscle

Home program controlled once six weeks

Home program which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations were recommended

Group Type EXPERIMENTAL

home program controlled once six weeks

Intervention Type OTHER

Home program which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations

Interventions

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soft tissue mobilization

soft tissue mobilization technique has three phases. First phase 'the passive mobilization phase' is applied by gentle but tight gripping of the SKM muscle two or three fingers below the muscle origo and the muscle is mobilized rhythmically in the antero-posterior direction. Secondly, after gently continue to hold the muscle the baby was encouraged to do active repetitive cervical rotation to the affected side by means of catching the babies attention with colored and sonorous toys. Third phase was mobilization with stretching. Caregiver holds the baby on his/ her affected side while the therapist gently grips and withholds the muscle. Therapist mobilizes the muscle in the antero-posterior direction and stretch the muscle

Intervention Type OTHER

home program controlled once six weeks

Home program which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Babies with congenital muscular torticollis and secondary deformational plagiocephaly
* Head tilt from 5 to 20 degrees
* Age between 0-6 months

Exclusion Criteria

* Have another health problem such as neurological, vertebral anomalies, craniosynostosis
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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hhotaman

Research Assistant, PhD, PT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilal KEKLİCEK, PhD,PT

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University,Faculty of Health Sciences Department of Physiotherapy

Locations

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Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hilal KEKLİCEK, PhD, PT

Role: CONTACT

0903123051576 ext. 138

Fatma UYGUR, Prof, PhD

Role: CONTACT

0903123051576 ext. 139

Facility Contacts

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Ayse KARADUMAN

Role: primary

Other Identifiers

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G014/14

Identifier Type: -

Identifier Source: org_study_id

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