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Perception-Action Approach Intervention for Infants With Congenital Muscular Torticollis (P-AA)

Primary Purpose

Congenital Muscular Torticollis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perception-Action Approach
Sponsored by
Rosalind Franklin University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Muscular Torticollis focused on measuring congenital muscular torticollis, infants, perception-action approach

Eligibility Criteria

undefined - 9 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Ability Pediatric Physical Therapy, LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perception-Action Approach

Arm Description

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.

Outcomes

Primary Outcome Measures

Still Photography
Change in the angle of habitual head deviation from midline assessed in a supine position
Arthrodial Goniometry
Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
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

Secondary Outcome Measures

Therapy Behavior Scale (TBS), Version 2.2
The TBS score documents therapy-related behavior during intervention sessions

Full Information

First Posted
September 13, 2016
Last Updated
August 9, 2018
Sponsor
Rosalind Franklin University of Medicine and Science
Collaborators
Ability Pediatric Physical Therapy, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02907801
Brief Title
Perception-Action Approach Intervention for Infants With Congenital Muscular Torticollis
Acronym
P-AA
Official Title
Effects of Perception-Action Approach Intervention in Infants With Congenital Muscular Torticollis: A Randomized Nonconcurrent Multiple Baseline Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
After a reliability pilot, main study stopped due to unrelated clinic closure.
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rosalind Franklin University of Medicine and Science
Collaborators
Ability Pediatric Physical Therapy, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study will have a randomized, nonconcurrent A-B multiple baseline design across subjects. The purpose of this study will be to investigate the immediate effects of the P-AA intervention on habitual head deviation from midline, active head rotation range of motion (ROM), 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, recruited from a private pediatric physical therapy (PT) practice. Baseline and intervention data will be collected 5 days per week, Monday through Friday, until the study is completed. The length of the baseline phase will be randomly assigned to each consecutively enrolled participant. The appropriate measurements will be taken at every baseline phase session but no intervention will be provided until the intervention phase is initiated. The intervention phase will include 5 daily PT sessions during which the P-AA intervention will be used, with outcome data collected at the end of each session. Additionally, the participants' therapy-related behavior during intervention sessions will be documented. Measurements of still photos and scoring of video recordings to evaluate the participants' habitual head deviation from midline and functional use of both sides of the body for movement and play will be performed by an assessor blind to the timing of when the photos and videos are obtained within the study. The active head rotation ROM measurements and assessment of therapy-related behavior will be performed by the treating therapists. Prior to initiating this research, a pilot reliability study will be conducted for all outcome measures. A total of 3 to 5 infants will be recruited for the pilot project. Fidelity of intervention will be evaluated during the pilot study using a checklist. During the main study, intervention adherence will be assessed by tracking attendance, session duration, and intervention frequency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Muscular Torticollis
Keywords
congenital muscular torticollis, infants, perception-action approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perception-Action Approach
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Perception-Action Approach
Other Intervention Name(s)
Perceptual-motor intervention, physical therapy
Intervention Description
Environmental set-up, gentle manual guidance, and caregiver education
Primary Outcome Measure Information:
Title
Still Photography
Description
Change in the angle of habitual head deviation from midline assessed in a supine position
Time Frame
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)
Title
Arthrodial Goniometry
Description
Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
Time Frame
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)
Title
Functional Symmetry Observation Scale (FSOS)
Description
Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play
Time Frame
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 Outcome Measure Information:
Title
Therapy Behavior Scale (TBS), Version 2.2
Description
The TBS score documents therapy-related behavior during intervention sessions
Time Frame
5 days (assessed after each of 5 intervention sessions)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Rahlin, PT, DHS, PCS
Organizational Affiliation
Rosalind Franklin University of Medicine and Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ability Pediatric Physical Therapy, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24076627
Citation
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.
Results Reference
background
PubMed Identifier
16357675
Citation
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. Erratum In: Pediatr Phys Ther. 2005 Winter;17(4):257.
Results Reference
background
PubMed Identifier
17053679
Citation
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.
Results Reference
background
PubMed Identifier
18201299
Citation
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. Erratum In: Dev Med Child Neurol. 2009 Mar;51(3):247.
Results Reference
background
PubMed Identifier
21068640
Citation
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.
Results Reference
background
PubMed Identifier
22729134
Citation
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.
Results Reference
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Perception-Action Approach Intervention for Infants With Congenital Muscular Torticollis

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