NCT02907801

Brief Summary

Infants with congenital muscular torticollis (CMT) display postural and functional asymmetry that interferes with their development. The use of the Perception-Action Approach (P-AA) intervention in infants with CMT is supported by a single case report and needs to be researched further to determine its efficacy. This study will investigate the immediate effects of the P-AA intervention on habitual head deviation from midline, active head rotation range of motion, and functional use of both sides of the body in infants with CMT. The participants will be 3 infants with CMT, aged birth to 9 months. A randomized, nonconcurrent A-B multiple baseline design across subjects will be used. The intervention phase will include 5 daily PT sessions, with outcome data collected at the end of each session. It is hypothesized that improvements on all outcome measures will be documented upon the initiation of the P-A Approach intervention, with the most substantial change expected in habitual head deviation from midline measured by still photography.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

September 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 10, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

September 13, 2016

Last Update Submit

August 9, 2018

Conditions

Congenital Muscular Torticollis

Keywords

congenital muscular torticollisinfantsperception-action approach

Outcome Measures

Primary Outcomes (3)

  • Still Photography

    Change in the angle of habitual head deviation from midline assessed in a supine position

    Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)

  • Arthrodial Goniometry

    Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides

    Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)

  • Functional Symmetry Observation Scale (FSOS)

    Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play

    Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)

Secondary Outcomes (1)

  • Therapy Behavior Scale (TBS), Version 2.2

    5 days (assessed after each of 5 intervention sessions)

Study Arms (1)

Perception-Action Approach

EXPERIMENTAL

Perception-Action Approach (P-AA) intervention components include environmental set-up for activity and participation in play, manual guidance in the form of light pressure applied to the infant's body in developmentally appropriate positions, and caregiver education in modifications to everyday activities consistent with the P-AA. All components are designed to promote spontaneous exploration of the environment by the infant by suggesting small, incremental changes in his/her perceptual-motor orientation and contact with the support surface. Intervention is progressed by gradually removing the environmental supports and therapist's hands to allow for spontaneous exploration of a newly found contact with the support surface or new body configuration.

Behavioral: Perception-Action Approach

Interventions

Perception-Action ApproachBEHAVIORAL

Environmental set-up, gentle manual guidance, and caregiver education

Also known as: Perceptual-motor intervention, physical therapy
Perception-Action Approach

Eligibility Criteria

AgeUp to 9 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age between birth and 9 months at the time of recruitment
  • diagnosis of CMT as documented in the medical record
  • parents/guardians agree not to have their child participate in any additional interventions for CMT during the course of the study

You may not qualify if:

  • diagnosis of neuromuscular torticollis, Sandifer syndrome, acute torticollis, benign paroxysmal torticollis, ocular torticollis, torticollis related to bony anomalies, or another non-muscular type of torticollis
  • being seen for torticollis by another health care provider
  • receiving a passive stretching intervention for CMT prior to referral for PT at the research site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ability Pediatric Physical Therapy, LLC

Anchorage, Alaska, 99508, United States

Location

Related Publications (6)

  • Kaplan SL, Coulter C, Fetters L. Physical therapy management of congenital muscular torticollis: an evidence-based clinical practice guideline: from the Section on Pediatrics of the American Physical Therapy Association. Pediatr Phys Ther. 2013 Winter;25(4):348-94. doi: 10.1097/PEP.0b013e3182a778d2.

    PMID: 24076627BACKGROUND

  • Rahlin M. TAMO therapy as a major component of physical therapy intervention for an infant with congenital muscular torticollis: a case report. Pediatr Phys Ther. 2005 Fall;17(3):209-18. doi: 10.1097/01.pep.0000179176.20035.f0.

    PMID: 16357675BACKGROUND

  • Tscharnuter I. Clinical Application of Dynamic Theory Concepts According to Tscharnuter Akademie for Movement Organization (TAMO) Therapy. Pediatr Phys Ther. 2002 Spring;14(1):29-37.

    PMID: 17053679BACKGROUND

  • Romeiser Logan L, Hickman RR, Harris SR, Heriza CB. Single-subject research design: recommendations for levels of evidence and quality rating. Dev Med Child Neurol. 2008 Feb;50(2):99-103. doi: 10.1111/j.1469-8749.2007.02005.x.

    PMID: 18201299BACKGROUND

  • Rahlin M, Sarmiento B. Reliability of still photography measuring habitual head deviation from midline in infants with congenital muscular torticollis. Pediatr Phys Ther. 2010 Winter;22(4):399-406. doi: 10.1097/PEP.0b013e3181f9d72d.

    PMID: 21068640BACKGROUND

  • Rahlin M, McCloy C, Henderson R, Long T, Rheault W. Development and content validity of the Therapy Behavior Scale. Infant Behav Dev. 2012 Jun;35(3):452-65. doi: 10.1016/j.infbeh.2012.03.001. Epub 2012 Jun 26.

    PMID: 22729134BACKGROUND

MeSH Terms

Conditions

Congenital torticollis

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Mary Rahlin, PT, DHS, PCS

    Rosalind Franklin University of Medicine and Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 20, 2016

Study Start

January 10, 2017

Primary Completion

March 26, 2018

Study Completion

March 26, 2018

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

US(1)