NCT02403011

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

March 15, 2015

Last Update Submit

November 6, 2015

Conditions

Congenital Muscular Torticollis

Keywords

Congenital Muscular TorticollisManual TherapyInfant

Outcome Measures

Primary Outcomes (2)

  • Head tilt with photographic method

    Baby lies supine while taking photo of baby's habitual head position. The angle between the two lines, connecting eyes pupils and connecting acromions, is assessed.

    Change from Baseline in head tilt at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks

  • plagiocephaly severity scale

    scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry.

    Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks

Secondary Outcomes (1)

  • Passive range of motion

    Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks

Study Arms (2)

Soft tissue mobilization group

EXPERIMENTAL

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

Other: soft tissue mobilization

Home program controlled once six weeks

EXPERIMENTAL

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

Other: home program controlled once six weeks

Interventions

soft tissue mobilizationOTHER

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

Soft tissue mobilization group
home program controlled once six weeksOTHER

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

Home program controlled once six weeks

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Have another health problem such as neurological, vertebral anomalies, craniosynostosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Congenital torticollis

Study Officials

  • Hilal KEKLİCEK, PhD,PT

    Hacettepe University,Faculty of Health Sciences Department of Physiotherapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilal KEKLİCEK, PhD, PT

CONTACT

0903123051576hhotaman23@gmail.com

Fatma UYGUR, Prof, PhD

CONTACT

0903123051576fztuygur@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, PhD, PT

Study Record Dates

First Submitted

March 15, 2015

First Posted

March 31, 2015

Study Start

January 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 9, 2015

Record last verified: 2015-11

Locations

TU(1)